GMDN Edma Codes

GMDN to EDMA code
correlation table
31 May 2005
GMDN Term GMDN Code EDMA Code EDMA Term
No Equivalent GMDN term 0 11 01 01 09 Angiotensin Converting Enzyme (CC) IC =>12.06.02.03

No Equivalent GMDN term 0 11 01 01 14 Creatine Kinase - MB "Activity"(CC) IC =>12.01.05.02
No Equivalent GMDN term 0 11 01 01 20 Lactate Dehydrogenase P ( LDH - P --> L )
No Equivalent GMDN term 0 11 04 03 06 Bilirubin - Electrodes
No Equivalent GMDN term 0 11 04 04 01 Reference Electrodes
No Equivalent GMDN term 0 11 04 04 02 Electrolyte Electrode Buffers and Solutions
No Equivalent GMDN term 0 11 04 04 04 Substrate Electrode Buffers and Solutions
No Equivalent GMDN term 0 11 04 04 05 Common Buffers and Solutions (Electrolytes)
No Equivalent GMDN term 0 11 04 04 90 Other Buffers and Solutions (Electrolytes)
No Equivalent GMDN term 0 11 30 01 01 Multiple Enzymes only - Clin. Chem Lab R.
No Equivalent GMDN term 0 11 30 01 02 Multiple Substrates only - Clin. Chem Lab R.
No Equivalent GMDN term 0 11 30 01 03 Multiple Electrolytes only - Clin. Chem Lab R.
No Equivalent GMDN term 0 11 30 01 11 Multiple Parameters (Mix of all) - Clin. Chem Lab R.
No Equivalent GMDN term 0 11 30 01 90 Other Multiple Clin. Chem Lab Reagents
No Equivalent GMDN term 0 11 30 04 02 Multiple Substrates only - Electrodes/Biosensors
No Equivalent GMDN term 0 11 30 04 03 Multiple Electrolytes only - Electrodes/Biosensors
No Equivalent GMDN term 0 11 30 04 04 Multiple Blood Gas only - Electrodes/Biosensors
No Equivalent GMDN term 0 11 30 04 11 Multiple Parameters (Mix of all) - Electrodes/Biosensors
No Equivalent GMDN term 0 11 30 04 90 Other Multiple Parameter - Electrodes/Biosensors
No Equivalent GMDN term 0 11 50 01 03 Unassayed Multicomponent Sera (CC)
No Equivalent GMDN term 0 11 50 01 90 Other Multicomponent Sera (CC)
No Equivalent GMDN term 0 11 50 03 03 Aqueous Standards (CC)
No Equivalent GMDN term 0 11 50 30 01 Multiple Parameter Calibrators and Standards Electrodes/Biosensors
No Equivalent GMDN term 0 11 50 90 90 Other, Other Controls Clinical Chemistry
No Equivalent GMDN term 0 11 70 01 05 Triglyceride Test Strips
No Equivalent GMDN term 0 11 70 01 06 Urea Test Strips
No Equivalent GMDN term 0 11 70 01 07 HbA1c Test Strips
No Equivalent GMDN term 0 11 70 01 50 Calibrators and Controls (Blood Test Strips)
No Equivalent GMDN term 0 11 70 03 02 Albumin in stool (Meconium)
No Equivalent GMDN term 0 11 70 03 90 Other Faeces Tests
No Equivalent GMDN term 0 11 70 90 90 Other Clin. Chem. Rapid Tests
No Equivalent GMDN term 0 11 90 01 01 Buffers (unassignable), Supplem. Reagents, etc (CC)
http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Page 1 of 108
No Equivalent GMDN term 0 11 90 01 10 Electrophoresis Media (unassignable)

No Equivalent GMDN term 0 12 01 01 30 Immunoelectrophoresis kits
No Equivalent GMDN term 0 12 01 01 31 Immunofixation kits
No Equivalent GMDN term 0 12 01 01 80 Buffers (unassignable), Supplem. Reagents, etc (Ig's)
No Equivalent GMDN term 0 12 02 01 06 Immunoglobulin E - Screen
No Equivalent GMDN term 0 12 02 01 08 Allergene specific IgA
No Equivalent GMDN term 0 12 02 01 09 Allergene specific IgG
No Equivalent GMDN term 0 12 03 01 10 Cancer Antigen 27.29
No Equivalent GMDN term 0 12 03 01 46 Cancer Associated Serum Antigen
No Equivalent GMDN term 0 12 03 02 90 Other Receptor Assays
No Equivalent GMDN term 0 12 03 03 01 HER-2/neu GT=>16 02 01 13 00
No Equivalent GMDN term 0 12 03 90 18 Protein S-100 B
No Equivalent GMDN term 0 12 04 01 12 Neonatal Thyroxine
No Equivalent GMDN term 0 12 05 01 13 Corticoid-binding Globulin
No Equivalent GMDN term 0 12 05 02 09 Glycoprotein a Subunit
No Equivalent GMDN term 0 12 05 02 10 Pregnancy associated Plasma Protein - A (Downs)
No Equivalent GMDN term 0 12 06 01 07 Thyrosin Phosphatase IA2 Antibodies
No Equivalent GMDN term 0 12 06 02 90 Other Renal metabolism tests
No Equivalent GMDN term 0 12 06 03 17 Tartrate-resistant Acid Phosphatase 5b
No Equivalent GMDN term 0 12 06 03 18 Procollagen Type I N terminal propeptide
No Equivalent GMDN term 0 12 06 04 90 Other Endocrine Hormones (Growth Factors)
No Equivalent GMDN term 0 12 06 05 06 a-Melanocite Stimulating Hormones
No Equivalent GMDN term 0 12 06 05 07 Neurotensin
No Equivalent GMDN term 0 12 06 05 08 Somatostatin
No Equivalent GMDN term 0 12 06 05 09 Substance P
No Equivalent GMDN term 0 12 06 05 90 Other Neoendocrine Function Assays
No Equivalent GMDN term 0 12 06 30 01 Adrenalin / Noradrenalin / Dopamin
No Equivalent GMDN term 0 12 06 30 90 Other Multiple Ind. A. Spec. Hormones
No Equivalent GMDN term 0 12 06 90 02 Gonadotropin-Releasing Hormone
No Equivalent GMDN term 0 12 06 90 12 Elastase (Pancreatic Polypeptide)
No Equivalent GMDN term 0 12 06 90 13 Adrenalin
No Equivalent GMDN term 0 12 06 90 14 Noradrenalin
No Equivalent GMDN term 0 12 06 90 15 Dopamine
No Equivalent GMDN term 0 12 06 90 16 Procalcitonin
No Equivalent GMDN term 0 12 06 90 17 Leptin
No Equivalent GMDN term 0 12 06 90 18 Motilin
No Equivalent GMDN term 0 12 07 01 06 Soluble Transferrin Receptor
No Equivalent GMDN term 0 12 07 01 07 Reticulocyte Haemoglobin Content
No Equivalent GMDN term 0 12 07 01 90 Other Anemia
No Equivalent GMDN term 0 12 07 30 01 Vitamin B 12 / Folate

Page 2 of 108
No Equivalent GMDN term 0 12 07 30 90 Other Multiple Anemia / Vitamine Tests

No Equivalent GMDN term 0 12 08 01 90 Other Cardiovascular TDM
No Equivalent GMDN term 0 12 08 04 90 Other Anti-asthma TDM
No Equivalent GMDN term 0 12 08 05 90 Other Anti-neoplastic TDM
No Equivalent GMDN term 0 12 08 06 04 Rapamycin (Sirolimus)
No Equivalent GMDN term 0 12 08 06 05 Mycophenolate
No Equivalent GMDN term 0 12 08 06 90 Other Immunosuppressant TDM
No Equivalent GMDN term 0 12 09 01 16 6-Acethylmorphium
No Equivalent GMDN term 0 12 09 02 19 Tox adulteration
No Equivalent GMDN term 0 12 10 01 90 Other ANA / ENA
No Equivalent GMDN term 0 12 10 02 05 Gal(ß1-3)
No Equivalent GMDN term 0 12 10 02 12 Anti-GQ1b
No Equivalent GMDN term 0 12 10 02 90 Other Neuro-Auto-Immunology
No Equivalent GMDN term 0 12 10 03 90 Other Thyroid-Auto-Immune Disease Tests
No Equivalent GMDN term 0 12 10 90 12 Sp 100 Antibodies
No Equivalent GMDN term 0 12 10 90 16 Antibodies to endomysial Autoantigenes
No Equivalent GMDN term 0 12 10 90 17 Antibodies to soluble Liverantigenes
No Equivalent GMDN term 0 12 10 90 18 Nucleosome Antibodies
No Equivalent GMDN term 0 12 10 90 19 Saccharomyces cerevisiae Antibodies
No Equivalent GMDN term 0 12 10 90 21 Tissue Transglutaminase Antibodies
No Equivalent GMDN term 0 12 10 90 22 Tissue Transglutaminase/ Gliadin Antibodies Combitest
No Equivalent GMDN term 0 12 10 90 24 LDL Antibodies
No Equivalent GMDN term 0 12 11 01 07 Anti-Staphylolysin (qualitative)
No Equivalent GMDN term 0 12 11 01 21 A-Streptococcal Screening
No Equivalent GMDN term 0 12 12 01 02 Carbo Hydrate Deficient Transferrin
No Equivalent GMDN term 0 12 12 90 90 Other Organ Function Assays
No Equivalent GMDN term 0 12 13 01 09 Homocysteine
No Equivalent GMDN term 0 12 13 01 90 Other Cardiac Proteins
No Equivalent GMDN term 0 12 50 01 30 Multi Constituents Immunochemistry Controls
No Equivalent GMDN term 0 12 70 01 01 Albumin incl. uAlbumin Rapid Test IC => 12 01 03 01
No Equivalent GMDN term 0 12 70 01 90 Other Specific Proteins Rapid Tests
No Equivalent GMDN term 0 12 70 03 90 Other Tumour Marker Rapid Tests
No Equivalent GMDN term 0 12 70 08 11 Theophylline - Rapid Test
No Equivalent GMDN term 0 12 70 08 90 Other TDM Rapid Tests
No Equivalent GMDN term 0 12 70 09 70 Multiple Drugs of Abuse/Toxicology Rapid Tests
No Equivalent GMDN term 0 12 70 11 01 C-Reactive Protein - Rapid Test
No Equivalent GMDN term 0 12 70 11 90 Other Rheumatoid - Inflammatory Rapid Tests
No Equivalent GMDN term 0 12 70 13 04 Brain Natriuric Peptide - Rapid Test
No Equivalent GMDN term 0 12 70 13 90 Other Cardiac Marker Rapid Tests
No Equivalent GMDN term 0 12 90 01 01 Antisera (monovalent and polyvalent)

Page 3 of 108
No Equivalent GMDN term 0 12 90 01 70 Buffers (unassignable ), Supplem. Reagents, etc (IC)

No Equivalent GMDN term 0 12 90 01 80 Coated Tubes and Beads (unassignable) (IC)
No Equivalent GMDN term 0 12 90 90 90 Other, Other Immunochemistry Reagents
No Equivalent GMDN term 0 13 01 02 90 Other Haemoglobin Testing
No Equivalent GMDN term 0 13 01 70 01 Haemoglobin (Hb)
No Equivalent GMDN term 0 13 01 70 02 Erythrocytes (Ery)
No Equivalent GMDN term 0 13 01 70 03 Haematocrit (HCT)
No Equivalent GMDN term 0 13 01 70 90 Other Rapid Haematology Tests
No Equivalent GMDN term 0 13 02 01 90 Other Global Coagulation Tests
No Equivalent GMDN term 0 13 02 02 21 Coagulation factor von Willebrand RCO
No Equivalent GMDN term 0 13 02 02 22 Coagulation factor von Willebrand CBA
No Equivalent GMDN term 0 13 02 04 90 Other Primary Hemostasis
No Equivalent GMDN term 0 13 02 05 09 Thrombin Activating Fibrinolysis Inhibitor
No Equivalent GMDN term 0 13 02 05 90 Other Fibrinolysis Tests
No Equivalent GMDN term 0 13 02 06 10 Heparin Cofactor II - Tissue Factor Pathway Inhibitor
No Equivalent GMDN term 0 13 02 06 12 Pro C Global
No Equivalent GMDN term 0 13 02 70 02 Activated Partial Thromboplastin Time Rapid Test
No Equivalent GMDN term 0 13 02 70 03 D-Dimer - Rapid Test
No Equivalent GMDN term 0 13 02 70 04 Activated Clotting Time Rapid Test
No Equivalent GMDN term 0 13 02 70 90 Other Haemostasis Rapid Tests
No Equivalent GMDN term 0 13 02 80 02 Citrate
No Equivalent GMDN term 0 13 02 80 80 Coated tubes (Citrate, Heparin etc.)
No Equivalent GMDN term 0 13 02 90 90 Other Haemostasis Reagents
No Equivalent GMDN term 0 13 03 02 01 Rhesus D
No Equivalent GMDN term 0 13 03 02 90 Other Rhesus Typing Assays
No Equivalent GMDN term 0 13 03 04 06 Enhancement Media (e.g. Bovine Albumin,LISS,PEG)
No Equivalent GMDN term 0 13 03 20 90 Other immunohaematology Controls
No Equivalent GMDN term 0 13 03 90 90 Other Other Immunohaematology Tests
No Equivalent GMDN term 0 13 05 01 90 Other Monoclonal Antibodies
No Equivalent GMDN term 0 13 06 01 03 Soluble Antigens / Receptors
No Equivalent GMDN term 0 13 06 01 06 Colony Stimulating Factors (G-CSF,M-CSF,GM-CSF)
No Equivalent GMDN term 0 13 06 01 90 Other Lymphokines /Immunmodulators
No Equivalent GMDN term 0 13 07 01 08 Stain solutions (Histology/Cytology)
No Equivalent GMDN term 0 13 07 01 09 Primary antisera for immunohistology
No Equivalent GMDN term 0 13 07 01 10 Secondary antisera for immunohistology
No Equivalent GMDN term 0 13 07 01 90 Other Histology / Cytology reagents
No Equivalent GMDN term 0 13 90 90 90 Other Haematology
No Equivalent GMDN term 0 14 01 01 02 DCM (susceptibility testing)
No Equivalent GMDN term 0 14 01 01 03 Raw materials for preparing DCM
No Equivalent GMDN term 0 14 01 02 21 Sample transport for NA Testing

Page 4 of 108
No Equivalent GMDN term 0 14 01 02 30 Dip Slides (Bacteriology)

No Equivalent GMDN term 0 14 01 02 90 Other Media in Tubes
No Equivalent GMDN term 0 14 01 03 03 Susceptibility Testing (Bottles)
No Equivalent GMDN term 0 14 01 03 90 Other Media in Bottles
No Equivalent GMDN term 0 14 01 04 90 Other Prepared Media in Plates
No Equivalent GMDN term 0 14 01 05 01 Broth only (Blood Culture - Manual)
No Equivalent GMDN term 0 14 01 05 02 Diphasic (Blood Culture - Manual)
No Equivalent GMDN term 0 14 01 05 03 Paediatric (Blood Culture - Manual)
No Equivalent GMDN term 0 14 01 05 90 Other Manual Blood Culture (Concentrators, Antibiotic Inactivators
No Equivalent GMDN term 0 14 01 06 10 Systems for Mycobacteria - Automated
No Equivalent GMDN term 0 14 01 06 90 Other Automated Blood Culture
No Equivalent GMDN term 0 14 01 07 90 Other Urine Screening (Bacteriology)
No Equivalent GMDN term 0 14 01 08 02 Other Stains
No Equivalent GMDN term 0 14 01 08 03 Gas Generating Kits
No Equivalent GMDN term 0 14 02 01 02 Non-fermenters - Automated
No Equivalent GMDN term 0 14 02 01 03 Streptococci - Automated
No Equivalent GMDN term 0 14 02 01 04 Staphylococci - Automated
No Equivalent GMDN term 0 14 02 01 06 Haemophilus & Neisseria - Automated
No Equivalent GMDN term 0 14 02 01 90 Other Automated Identification
No Equivalent GMDN term 0 14 02 02 03 Streptococci - Manual
No Equivalent GMDN term 0 14 02 02 04 Staphylococci - Manual
No Equivalent GMDN term 0 14 02 02 08 Rapid Single Tests (Catalase, Oxidase etc.)
No Equivalent GMDN term 0 14 02 03 02 Streptococci
No Equivalent GMDN term 0 14 02 03 04 Meningitis Causative Agents
No Equivalent GMDN term 0 14 02 03 90 Other Immunological Identification
No Equivalent GMDN term 0 14 02 04 01 Break-point Systems (Automated)
No Equivalent GMDN term 0 14 02 04 02 MIC Systems - Automated
No Equivalent GMDN term 0 14 02 04 03 Combined Susceptibility & Identification Systems (Auto)
No Equivalent GMDN term 0 14 02 04 90 Other Automated Susceptibility Systems
No Equivalent GMDN term 0 14 02 05 03 Multipoint Systems
No Equivalent GMDN term 0 14 02 05 05 Rapid Single Tests (Cefinase etc.)
No Equivalent GMDN term 0 14 02 06 01 Nucleic Acid Identification - manual
No Equivalent GMDN term 0 14 02 06 02 Nucleic Acid Identification - automated
No Equivalent GMDN term 0 14 03 01 90 Other DCM (Mycology)
No Equivalent GMDN term 0 14 03 02 90 Other Prepared Media in Plates (Mycology)
No Equivalent GMDN term 0 14 03 03 01 Tubes and Bottled Media for Yeasts and Fungi
No Equivalent GMDN term 0 14 03 03 02 Dip Slides (Mycology)
No Equivalent GMDN term 0 14 03 03 90 Other Tubes Media for yeasts and Fungi
No Equivalent GMDN term 0 14 03 04 04 Identification Systems for Yeasts and Fungi / NA
No Equivalent GMDN term 0 14 03 05 90 Other Serological Identification of Yeasts and Fungi

Page 5 of 108
No Equivalent GMDN term 0 14 03 06 90 Other Susceptibility Systems for yeasts and Fungi
No Equivalent GMDN term 0 14 04 01 03 Serum for Tissue Culture
No Equivalent GMDN term 0 14 04 01 04 Other Tissue Culture Additives and Solutions
No Equivalent GMDN term 0 14 04 01 90 Other Virology ( Microbiology ) Reagents
No Equivalent GMDN term 0 14 05 01 01 Parasitology Extraction Reagents
No Equivalent GMDN term 0 14 05 01 90 Other Parasitology Stains
No Equivalent GMDN term 0 14 70 01 90 Other Microbiology Rapid Tests
No Equivalent GMDN term 0 15 01 02 90 Other Gonococci Reagents
No Equivalent GMDN term 0 15 01 03 90 Other Syphilis Reagents
No Equivalent GMDN term 0 15 01 04 90 Other H. Pylori Reagents
No Equivalent GMDN term 0 15 01 05 90 Other Legionella Reagents
No Equivalent GMDN term 0 15 01 06 05 Lyme Antibody IgG
No Equivalent GMDN term 0 15 01 06 06 Lyme Antibody IgM
No Equivalent GMDN term 0 15 01 06 90 Other Lyme Borelliosis Reagents
No Equivalent GMDN term 0 15 01 07 90 Other Mycobacteria Reagents
No Equivalent GMDN term 0 15 01 08 90 Other Mycoplasma Reagents
No Equivalent GMDN term 0 15 01 09 40 Pseudomonas Detection by NA Reagents
No Equivalent GMDN term 0 15 01 09 90 Other Pseudomonas Aeruginosa Reagents
No Equivalent GMDN term 0 15 01 10 90 Other Salmonella Reagents
No Equivalent GMDN term 0 15 01 11 90 Other Streptococci Reagents
No Equivalent GMDN term 0 15 01 12 11 Staphylotoxin
No Equivalent GMDN term 0 15 01 12 90 Other Staphylococci Reagents
No Equivalent GMDN term 0 15 01 13 01 Listeria Antigen Detection
No Equivalent GMDN term 0 15 01 13 03 Listeria Antibody Assays
No Equivalent GMDN term 0 15 01 13 90 Other Listeria Reagents
No Equivalent GMDN term 0 15 01 14 90 Other Campylobacter Reagents
No Equivalent GMDN term 0 15 01 15 40 E. Coli Detection by NA Reagents
No Equivalent GMDN term 0 15 01 15 90 Other E. Coli Reagents
No Equivalent GMDN term 0 15 01 40 01 Brucella - NA Reagents
No Equivalent GMDN term 0 15 01 40 02 Clostridium difficile - NA Reagents
No Equivalent GMDN term 0 15 01 40 03 Coxiella - NA Reagents
No Equivalent GMDN term 0 15 01 40 04 Leptospira - NA Reagents
No Equivalent GMDN term 0 15 01 40 05 Rickettsia - NA Reagents
No Equivalent GMDN term 0 15 01 40 06 Yersinia - NA Reagents
No Equivalent GMDN term 0 15 01 40 07 Bordetella pertussis / parapertussis - NA Reagents
No Equivalent GMDN term 0 15 01 40 08 Diphteria (Corynebacterium D.) - NA Reagents
No Equivalent GMDN term 0 15 01 40 09 Tetanus (Clostridium T.) - NA Reagents
No Equivalent GMDN term 0 15 01 40 12 Proteus - NA Reagents
No Equivalent GMDN term 0 15 01 40 13 Pseudomonas - NA Reagents
No Equivalent GMDN term 0 15 01 40 90 Other Other Bacteriology - NA Reagents

Page 6 of 108
No Equivalent GMDN term 0 15 02 01 40 Hepatitis A Virus - NA Reagents

No Equivalent GMDN term 0 15 02 01 90 Other HAV Reagents
No Equivalent GMDN term 0 15 02 03 90 Other HCV Reagents
No Equivalent GMDN term 0 15 02 04 90 Other HDV Reagents
No Equivalent GMDN term 0 15 02 05 07 HEV Antibody - Confirmatory
No Equivalent GMDN term 0 15 02 05 90 Other HEV Reagents
No Equivalent GMDN term 0 15 02 07 90 Other HGV Reagents
No Equivalent GMDN term 0 15 02 24 01 HXV Antigen
No Equivalent GMDN term 0 15 02 24 02 HXV Antigen - Confirmatory
No Equivalent GMDN term 0 15 02 24 04 HXV Antibody (Total)
No Equivalent GMDN term 0 15 02 24 05 HXV Antibody IgG
No Equivalent GMDN term 0 15 02 24 06 HXV Antibody IgM
No Equivalent GMDN term 0 15 02 24 40 Hepatitis X Virus - NA Reagents
No Equivalent GMDN term 0 15 02 24 90 Other HXV Reagents
No Equivalent GMDN term 0 15 02 90 90 Other Hepatitis Virus Reagents
No Equivalent GMDN term 0 15 03 02 01 HIV 2 Antigen
No Equivalent GMDN term 0 15 03 02 40 HIV 2 - NA Reagents
No Equivalent GMDN term 0 15 03 02 90 Other HIV 2 Reagents
No Equivalent GMDN term 0 15 03 10 40 HIV P24 - NA Reagents
No Equivalent GMDN term 0 15 03 20 09 HIV Multiple Ag/Ab Combi Test
No Equivalent GMDN term 0 15 03 20 40 HIV Multiple - NA Reagents
No Equivalent GMDN term 0 15 03 20 90 Other HIV Multiple Reagents
No Equivalent GMDN term 0 15 03 30 90 Other HTLV I Reagents
No Equivalent GMDN term 0 15 03 31 90 Other HTLV II Reagents
No Equivalent GMDN term 0 15 03 40 90 Other HTLV Multiple Reagents
No Equivalent GMDN term 0 15 04 01 90 Other Rubella Virus Reagents
No Equivalent GMDN term 0 15 04 03 08 HSV 1 IgG
No Equivalent GMDN term 0 15 04 03 09 HSV 1 IgM
No Equivalent GMDN term 0 15 04 03 90 Other HSV Reagents
No Equivalent GMDN term 0 15 04 40 01 Adenovirus - NA Reagents
No Equivalent GMDN term 0 15 04 40 02 Enterovirus - NA Reagents
No Equivalent GMDN term 0 15 04 40 04 Influenza & Para Influenza - NA Reagents
No Equivalent GMDN term 0 15 04 40 05 Respiratory Syncytial Virus (RSV) - NA Reagents
No Equivalent GMDN term 0 15 04 40 06 Rotavirus - NA Reagents
No Equivalent GMDN term 0 15 04 40 07 Measles - NA Reagents
No Equivalent GMDN term 0 15 04 40 08 Mumps / Parotitis - NA Reagents
No Equivalent GMDN term 0 15 04 40 09 Parvovirus B 19 - NA Reagents
No Equivalent GMDN term 0 15 04 40 10 Varicella Zoster Virus - NA Reagents
No Equivalent GMDN term 0 15 04 40 11 Dengue Virus - NA Reagents
No Equivalent GMDN term 0 15 04 40 12 FSME Virus - NA Reagents

Page 7 of 108
No Equivalent GMDN term 0 15 04 40 13 LCM Virus - NA Reagents

No Equivalent GMDN term 0 15 04 40 14 Hantavirus / Bunyavirus - NA Reagents
No Equivalent GMDN term 0 15 04 80 11 Dengue Virus
No Equivalent GMDN term 0 15 04 80 12 FSME Virus
No Equivalent GMDN term 0 15 04 80 14 Hantavirus / Bunyavirus
No Equivalent GMDN term 0 15 04 90 90 Other Other Virology Reagents
No Equivalent GMDN term 0 15 05 01 90 Other Toxoplasma Antibody
No Equivalent GMDN term 0 15 30 02 40 HCV / HIV Combination - NA Reagents
No Equivalent GMDN term 0 15 30 02 90 Other Multiple Viruses
No Equivalent GMDN term 0 15 50 01 30 Multiconstituent Controls - Inf.Imm.
No Equivalent GMDN term 0 15 50 01 90 Other Controls Inf. Immunology
No Equivalent GMDN term 0 15 70 01 01 Chlamydia AG - Rapid Test
No Equivalent GMDN term 0 15 70 01 90 Other Bacteriology Rapid Tests
No Equivalent GMDN term 0 15 70 02 90 Other Hepatitis Viruses Rapid Tests
No Equivalent GMDN term 0 15 70 03 01 HIV 1 - Rapid Test
No Equivalent GMDN term 0 15 70 03 90 Other Retroviruses Rapid Tests
No Equivalent GMDN term 0 15 70 90 02 RSV - Rapid Test
No Equivalent GMDN term 0 15 70 90 03 Mononucleosis - Rapid Test Inf. Imm.=>15 04 04 11
No Equivalent GMDN term 0 15 70 90 90 Other Other Virology Rapid Tests
No Equivalent GMDN term 0 15 90 90 01 Buffers (unassignable ), Supplem. Reagents, etc
No Equivalent GMDN term 0 15 90 90 40 Supplem. Reagents, etc - NA Reagents
No Equivalent GMDN term 0 15 90 90 90 Other Other Infectious Immunology Reagents
No Equivalent GMDN term 0 16 01 01 01 Cystic Fibrosis
No Equivalent GMDN term 0 16 01 01 02 Duchenne Muscular Dystrophy
No Equivalent GMDN term 0 16 01 01 03 Factor V Leiden
No Equivalent GMDN term 0 16 01 01 04 Fragile X Syndrome
No Equivalent GMDN term 0 16 01 01 05 Haemochromatosis
No Equivalent GMDN term 0 16 01 01 06 Haemophilia
No Equivalent GMDN term 0 16 01 01 07 Huntington Chorea
No Equivalent GMDN term 0 16 01 01 08 Polycystic Kidney Disease
No Equivalent GMDN term 0 16 01 01 10 Tay Sachs Disease
No Equivalent GMDN term 0 16 01 01 11 Thalassaemia
No Equivalent GMDN term 0 16 01 01 12 Friedreich's Ataxia
No Equivalent GMDN term 0 16 01 01 13 Spihocerebellar Ataxins Type 1,2,3,6,7,8
No Equivalent GMDN term 0 16 01 01 14 Prothrombin Mutation
No Equivalent GMDN term 0 16 01 01 90 Other Monogenetic Disorders Tests
No Equivalent GMDN term 0 16 01 02 01 Alzheimer's Disease
No Equivalent GMDN term 0 16 01 02 02 Asthma
No Equivalent GMDN term 0 16 01 02 03 Atherosclerosis
No Equivalent GMDN term 0 16 01 02 04 Diabetes

Page 8 of 108
No Equivalent GMDN term 0 16 01 02 05 Hypertension

No Equivalent GMDN term 0 16 01 02 06 Multiple Sclerosis
No Equivalent GMDN term 0 16 01 02 07 Osteoporosis
No Equivalent GMDN term 0 16 01 02 90 Other Polygenetic Disorders Tests
No Equivalent GMDN term 0 16 01 04 01 HLA-Typing
No Equivalent GMDN term 0 16 01 04 90 Other Polymorphism Tests
No Equivalent GMDN term 0 16 02 01 01 p53
No Equivalent GMDN term 0 16 02 01 02 k-ras
No Equivalent GMDN term 0 16 02 01 03 BRCA 1+2
No Equivalent GMDN term 0 16 02 01 04 ret
No Equivalent GMDN term 0 16 02 01 05 c-myc
No Equivalent GMDN term 0 16 02 01 06 HNPCC
No Equivalent GMDN term 0 16 02 01 07 APC
No Equivalent GMDN term 0 16 02 01 08 t(9;22)
No Equivalent GMDN term 0 16 02 01 11 inv (16)
No Equivalent GMDN term 0 16 02 01 12 Telomerase
No Equivalent GMDN term 0 16 02 01 13 HER-2/neu
No Equivalent GMDN term 0 16 02 01 90 Other Acquired Gene or Chromosome Alteration Tests
No Equivalent GMDN term 0 21 01 30 01 CH Consumables
No Equivalent GMDN term 0 21 03 10 01 IM Hardware + dedicated accessories + software
No Equivalent GMDN term 0 21 03 30 01 IM Consumables
No Equivalent GMDN term 0 21 04 30 01 GE Consumables
No Equivalent GMDN term 0 21 05 30 01 EP Consumables
No Equivalent GMDN term 0 21 07 30 01 Diabetes Management Consumables
No Equivalent GMDN term 0 21 07 30 09 Other RT_IC Consumables
No Equivalent GMDN term 0 21 09 10 01 Other_CI Hardware + dedicated accessories + software
No Equivalent GMDN term 0 21 09 30 01 Other_CI Consumables
No Equivalent GMDN term 0 23 02 30 01 HS Consumables
No Equivalent GMDN term 0 23 03 30 01 BG Consumables
No Equivalent GMDN term 0 23 04 30 01 FC Consumables
No Equivalent GMDN term 0 23 07 30 01 RT_HHC Consumables
No Equivalent GMDN term 0 24 02 30 01 BC Consumables
No Equivalent GMDN term 0 24 02 30 02 MB Consumables
No Equivalent GMDN term 0 25 01 10 01 II Hardware + dedicated accessories + software
No Equivalent GMDN term 0 25 07 10 01 RT_II Hardware + dedicated accessories + software
No Equivalent GMDN term 0 25 07 30 01 RT_II Consumables
No Equivalent GMDN term 0 26 01 30 01 NA Consumables
No Equivalent GMDN term 0 27 01 10 01 MA Hardware + dedicated accessories + software

Page 9 of 108
No Equivalent GMDN term 0 27 01 30 01 MA Consumables

No Equivalent GMDN term 0 28 01 30 01 SP Consumables
No Equivalent GMDN term 0 29 01 30 01 Other Consumables
Microhaematocrit centrifuge 10779 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Tabletop centrifuge 10780 28 01 10 01 SP Hardware + accessories + software
Analyser, laboratory, haematology, cell counting, manual 11996 23 01 10 01 CC Hardware + dedicated accessories + software
Blood gas monitor 12586 21 04 10 01 GE Hardware + dedicated accessories + software
Blood gas monitor, carbon dioxide 12588 21 04 10 01 GE Hardware + dedicated accessories + software
Oxygen monitor, transcutaneous 12592 00 00 00 00 Not for IVD use
pH monitor 12634 00 00 00 00 Not for IVD use
Osmometer 12842 00 00 00 00 Not for IVD use
Spectrophotometer, atomic absorption 15079 21 04 10 01 GE Hardware + dedicated accessories + software
Spectrophotometer, fluorescence 15080 21 01 10 01 CH Hardware + dedicated accessories + software
Spectrophotometer, infrared 15081 21 01 10 01 CH Hardware + dedicated accessories + software
Spectrophotometer, ultraviolet 15082 21 01 10 01 CH Hardware + dedicated accessories + software
Spectrophotometer, ultraviolet/visible light 15083 21 01 10 01 CH Hardware + dedicated accessories + software
Spectrophotometer, visible 15084 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, laboratory, body fluids, alcohol 15089 21 07 10 09 Other RT_CI Hardware + dedicated accessories + software
Analyser, laboratory, body fluids, amino acid 15090 21 02 10 01 IC Hardware + dedicated accessories + software
Analyser, laboratory, microbiology, susceptibility 15091 24 01 10 01 SI Hardware + dedicated accessories + software
Analyser, laboratory, blood, urea nitrogen 15092 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, laboratory, haematology, coagulation, automated 15098 23 02 10 01 HS Hardware + dedicated accessories + software
Analyser, laboratory, body fluids, electrolyte 15100 21 04 10 01 GE Hardware + dedicated accessories + software
Analyser, laboratory, body fluids, enzyme 15101 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, laboratory, body fluids, glucose 15102 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, laboratory, body fluids, nitrogen 15103 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, laboratory, haematology, platelet aggregation 15104 23 02 10 01 HS Hardware + dedicated accessories + software
Bilirubinometer 15109 21 01 10 01 CH Hardware + dedicated accessories + software
Cytometer, manual 15112 23 05 10 01 HC Hardware + dedicated accessories + software
Centrifuge, floor 15116 28 01 10 01 SP Hardware + accessories + software
Centrifuge, refrigerated 15117 28 01 10 01 SP Hardware + accessories + software
Analyser, laboratory, body fluids, chloride 15118 21 04 10 01 GE Hardware + dedicated accessories + software
Laboratory information system 15124 29 01 10 Other Hardware + dedicated accessories + software
Counter, bacteria 15125 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Cytometer, manual, differential 15132 23 05 10 01 HC Hardware + dedicated accessories + software
Slide dispenser 15135 23 05 30 01 HC Consumables
Photofluorometer 15141 21 02 10 01 IC Hardware + dedicated accessories + software
Freezer, blood plasma 15144 00 00 00 00 Not for IVD use
Analyser, laboratory, haematology, haemoglobin 15146 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Immunofluorescence equipment 15150 21 02 10 01 IC Hardware + dedicated accessories + software

Page 10 of 108
Mixer, clinical laboratory 15161 00 00 00 00 Not for IVD use

Pump, laboratory 15168 00 00 00 00 Not for IVD use
Sedimentation rate unit 15177 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Slide stainer, haematology 15182 23 05 10 01 HC Hardware + dedicated accessories + software
Slide stainer, histology 15183 23 05 10 01 HC Hardware + dedicated accessories + software
RIA (RadioImmunoAssay) analyser 15301 21 02 10 01 IC Hardware + dedicated accessories + software
Analyser, laboratory, clinical chemistry 15551 21 01 10 01 CH Hardware + dedicated accessories + software
Coagulation analyser, manual 15552 23 02 10 01 HS Hardware + dedicated accessories + software
Spectrophotometer 15601 21 01 10 01 CH Hardware + dedicated accessories + software
Pipetter 15663 28 01 10 01 SP Hardware + accessories + software
Analyser, laboratory, blood gas/pH 15709 21 04 10 01 GE Hardware + dedicated accessories + software
Centrifuge tube adapter 15714 28 01 10 01 SP Hardware + accessories + software
Blood potassium monitor 15776 21 04 10 01 GE Hardware + dedicated accessories + software
Analyser, laboratory, breath, helium 15892 00 00 00 00 Not for IVD use
Carbon dioxide monitor, transcutaneous 15970 00 00 00 00 Not for IVD use
Analyser, laboratory, microbiology, blood culture, automated 15973 24 02 10 01 BC & MB Hardware + dedicated accessories + software
Analyser, laboratory, haematology, blood grouping 16014 23 03 10 01 BG Hardware + dedicated accessories + software
Bilirubinometer, cutaneous 16166 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, laboratory, immunoassay, photometric, enzyme 16217 21 02 10 01 IC Hardware + dedicated accessories + software
Analyser, laboratory, immunoassay, fluorimetric 16218 21 02 10 01 IC Hardware + dedicated accessories + software
Dispenser, antibiotic sensitivity disk 16273 24 01 30 01 SI Consumables
Analyser, Laboratory, clinical chemistry, automated, discrete 16299 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, laboratory, clinical chemistry, automated, centrifugal 16300 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, laboratory, clinical chemistry, automated, continuous flow 16301 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, laboratory, clinical chemistry, manual 16302 21 01 10 01 CH Hardware + dedicated accessories + software
Platelet aggregation recorder, automated 16373 23 02 10 01 HS Hardware + dedicated accessories + software
Hematofluorometer 16374 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Counter, platelet, automated 16377 23 01 10 01 CC Hardware + dedicated accessories + software
Analyser, laboratory, urine, automated 16378 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, laboratory, radioimmunoassay, automated 16382 21 02 10 01 IC Hardware + dedicated accessories + software
Analyser, laboratory, radioimmunoassay, semiautomated 16383 21 02 10 01 IC Hardware + dedicated accessories + software
Diluter, blood cell 16404 28 01 10 01 SP Hardware + accessories + software
Concentrator, specimen 16456 28 01 10 01 SP Hardware + accessories + software
Blood glucose monitor, portable 16488 21 07 10 01 Diabetes Management Hardware + dedicated accessories + software
Disrupter, cell 16525 00 00 00 00 Not for IVD use
Analyser, laboratory, body fluids, electrolyte, flame photometer 16530 21 04 10 01 GE Hardware + dedicated accessories + software
Photometer, reflectance 16531 23 07 10 01 RT_HHC Hardware + dedicated accessories + software
Cytometer, flow 16609 23 04 10 01 FC Hardware + dedicated accessories + software
Analyser, point-of-care, whole blood, coagulation 16749 23 07 10 01 RT_HHC Hardware + dedicated accessories + software
Cytological centrifuge 16765 28 01 10 01 SP Hardware + accessories + software

Page 11 of 108
Analyser, laboratory, body fluids, lactate 16773 21 01 10 01 CH Hardware + dedicated accessories + software
Bath, water, plasma-thawing 16796 00 00 00 00 Not for IVD use
Centrifuge, cell washing, automatic 16815 28 01 10 01 SP Hardware + accessories + software
Blood grouping system, automated 16817 23 03 10 01 BG Hardware + dedicated accessories + software
Analyser, laboratory, body fluids, electrolyte, ion-selective 16818 21 04 10 01 GE Hardware + dedicated accessories + software
Analyser, laboratory, body fluids, electrolyte, coulometric 16819 21 04 10 01 GE Hardware + dedicated accessories + software
Analyser, laboratory, radioimmunoassay, manual 16865 21 02 10 01 IC Hardware + dedicated accessories + software
Cytometer, automated, flow 16867 23 04 10 01 FC Hardware + dedicated accessories + software
Syringe, gas/liquid chromatography 16876 00 00 00 00 Not for IVD use
Analyser, laboratory, urine, semiautomated 16887 21 01 10 01 CH Hardware + dedicated accessories + software
Densitometer, laboratory, scanning light 16905 21 05 10 01 EP Hardware + dedicated accessories + software
Analysers, laboratory, immunoassay, nephelometric 16908 21 02 10 01 IC Hardware + dedicated accessories + software
Calibrator, blood gas 16929 11 50 90 01 Blood gas control
Analyser, laboratory, body fluids, calcium 16940 21 04 10 01 GE Hardware + dedicated accessories + software
Slide stainer, microbiological 16961 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Analyser, laboratory, semen 16984 21 02 10 01 IC Hardware + dedicated accessories + software
Antimicrobial reagent disk 17005 14 02 05 02 Impregnated Disks, Multi-disks & Tablets
Blood grouping/typing serum 17013 13 03 01 02 ABO sera
Culture media 17014 14 01 Bacteriology - Culture
Culture medium, differential, microbiological 17016 14 02 Bacteriology - Identification & Susceptibility Testing
Culture medium, mycobacteriology 17017 14 01 03 10 Mycobacteria media (Bottles)
Mycology culture media 17018 14 03 Mycology
Culture media, Mycoplasma 17019 14 02 02 07 Mycoplasma - Manual
Culture medium, selective, microbiological 17021 14 01 Bacteriology - Culture
Culture media, tissue 17022 14 04 01 02 Media for Tissue Culture
Culture medium, virology 17023 14 04 Viral Culture
Fixative, electron microscopy 17025 13 07 01 05 Fixing reagents (Histology/Cytology)
Fixative, light microscopy 17026 13 07 01 05 Fixing reagents (Histology/Cytology)
Reagent, decalcifying, electron microscopy 17049 13 02 80 90 Other Auxiliary Reagents (Haemostasis)
Reagent, decalcifying, light microscopy 17050 13 02 80 90 Other Auxiliary Reagents (Haemostasis)
Reagent, quality control, coagulation 17059 13 02 50 Haemostasis Controls
Reagent, quality control, urinalysis 17067 11 50 90 02 Urine Control
Stain, haematology 17080 13 01 03 01 Histo/Cyto stains
Stain, light microscopy, cytology 17083 13 01 03 01 Histo/Cyto stains
Stain, light microscopy, histology 17084 13 01 03 01 Histo/Cyto stains
Stain, microbiology 17085 14 01 08 Stains, Buffers etc (Bacteriology)
Analyser, laboratory, blood, glycohemoglobin 17109 21 07 10 09 Other RT_CI Hardware + dedicated accessories + software
Reagent, quality control, blood gas/pH 17128 11 50 90 01 Blood gas control
Analyser, laboratory, body fluids, catecholamine 17173 21 02 10 01 IC Hardware + dedicated accessories + software
Analyser, laboratory, haematology, coagulation, semiautomated 17176 23 02 10 01 HS Hardware + dedicated accessories + software

Page 12 of 108
Centrifuge, floor, nonrefrigerated 17177 28 01 10 01 SP Hardware + accessories + software

Analyser, laboratory, body fluids, creatinine 17182 21 01 10 01 CH Hardware + dedicated accessories + software
Reagent, allergen specific immunoglobulin E 17254 12 02 01 03 Immunoglobulin E - Specific, monotest/monoresult
Reagent, allergen specific immunoglobulin G 17255 12 01 01 05 Immunoglobulin G
Reagent, alpha-1-acid glycoprotein 17256 12 01 90 01 a1-Acid Glycoprotein ( Orosomucoid )
Reagent, alpha-1-antitrypsin 17257 12 01 90 02 a1-Antitrypsin ( Protease inhibitor )
Reagent, alpha-2-macroglobulin 17258 12 01 90 03 a2-Macroglobulin
Reagent, alpha fetoprotein 17259 12 03 90 01 Alphafetoprotein
Reagent, antideoxyribonucleoprotein/anti-DNA 17264 12 10 01 05 ds DNA - Antibodies
Reagent, antimitochondrial antibody 17267 12 10 90 02 Anti-Mitochondrial Antibodies
Reagent, anti-ndna antibody 17268 12 10 01 05 ds DNA - Antibodies
Reagent, antinuclear (HEp-2 cell substrate) antibody 17269 12 10 01 01 ANA Screening
Reagent, antinuclear (KB cell substrate) antibody 17270 12 10 01 01 ANA Screening
Reagent, antinuclear (tissue substrate) antibody 17271 12 10 01 01 ANA Screening
Reagent, antinuclear/autoantibody multiple test system 17273 12 10 01 01 ANA Screening
Reagent, antiparietal cell antibody 17274 12 10 90 11 Parietal Cell Antibodies
Reagent, anti-smooth muscle antibody 17276 12 10 01 11 Sm
Reagent, antistreptolysin O 17278 12 11 01 05 Anti-Streptolysin/Anti-Streptolysin O (qualitative)
Reagent, antistreptolysin O/antideoxy-ribonuclease 17279 12 11 01 05 Anti-Streptolysin/Anti-Streptolysin O (qualitative)
Reagent, antithyroglobulin antibody 17280 12 10 03 04 Thyroglobulin Autoantibodies
Reagent, antithyroid-microsomal antibody 17282 12 10 03 01 Thyroid Peroxidase (incl. Microsomal) Antibodies
Reagent, Aspergillus antibody 17284 15 06 01 01 Aspergillus
Reagent, Bordetella pertussis antibody 17288 15 01 90 07 Bordetella pertussis / parapertussis
Reagent, Brucella antibody 17289 15 01 90 01 Brucella
Reagent, C reactive protein 17290 12 11 01 09 C-Reactive Protein IC=> 12 70 11 01
Reagent, Candida albicans detection 17291 15 06 01 02 Candida albicans
Reagent, Candida albicans antibody 17292 15 06 01 02 Candida albicans
Reagent, carcinoembryonic antigen 17293 12 03 01 31 Carcinoembryonic Antigen
Reagent, ceruloplasmin 17295 12 01 03 02 Ceruloplasmin
Reagent, Chlamydia trachomatis detection 17296 15 01 01 01 Chlamydia Antigen Detection
Reagent, Legionella pneumophila detection 17297 15 01 05 01 Legionella Antigen Detection
Reagent, Legionella species 17298 15 01 05 01 Legionella Antigen Detection
Reagent, measles (rubeola) antibody 17307 15 04 80 07 Measles
Reagent, mumps virus antibody 17309 15 04 80 08 Mumps / Parotitis
Reagent, Mycoplasma pneumoniae detection 17310 15 01 08 01 Mycoplasma Antigen Detection
Reagent, Mycoplasma pneumoniae antibody 17311 15 01 08 03 Mycoplasma Antibody Assays
Reagent, Mycoplasma/ureaplasma detection 17312 15 01 08 01 Mycoplasma Antigen Detection
Reagent, myelin basic protein 17313 12 10 02 07 Anti-MAG (Myelin Associated Glycoprotein)
Reagent, myoglobin 17314 12 13 01 05 Myoglobin
Reagent, Neisseria species detection 17315 15 01 90 11 Neisseria meningitidis

Page 13 of 108
Reagent, Neisseria gonorrhoeae detection 17316 15 01 02 01 Gonococcal Antigen Detection

Reagent, Neisseria meningitidis detection 17317 15 01 90 11 Neisseria meningitidis
Reagent, papillomavirus detection 17319 15 04 80 03 Human Papilloma Virus
Reagent, plasminogen 17322 13 02 05 05 Plasminogen
Reagent, plasminogen activator 17323 13 02 05 06 Plasminogen Activator-Inhibitors
Reagent, Chlamydia trachomatis antibody 17325 15 01 01 03 Chlamydia Antibody Assays Total
Reagent, circulating immune complexes 17326 12 11 01 08 Circulating Immune Complexes
Reagent, Coccidiodes immitis antibody 17329 15 06 01 90 Other Mycology Immunoassays
Reagent, Cryptococcus neoformans 17332 15 06 01 90 Other Mycology Immunoassays
Reagent, Cryptococcus neoformans antibody 17333 15 06 01 90 Other Mycology Immunoassays
Reagent, cytomegalovirus antibody 17334 15 04 02 04 CMV Antibodies - Total
Reagent, cytomegalovirus antibody-IgG/IgM 17335 15 04 02 05 CMV IgG
Reagent, cytomegalovirus antibody-IgM specific 17336 15 04 02 06 CMV IgM
Reagent, Entamoeba histolytica antibody 17337 15 05 10 01 Entamoeba histolytica
Reagent, Enterobacteriaceae detection 17338 14 02 02 01 Enterobacteriaceae - Manual
Reagent, Epstein-Barr virus antibody 17339 15 04 04 04 EBV Antibodies
Reagent, Epstein-Barr virus antibody-IgM specific 17340 15 04 04 04 EBV Antibodies
Reagent, ferritin 17342 12 07 01 02 Ferritin
Reagent, fibrin degradation products 17343 13 02 05 02 Fibrinogen Degradation Products
Reagent, Franciscella tularensis antibody 17344 15 01 90 90 Other Other Bacteriology Immunoassays
Reagent, Gardnerella vaginalis 17347 15 05 10 90 Other Parasitology
Reagent, Gram stain 17348 14 01 08 01 Gram's Stain
Reagent, Haemophilus species 17349 15 01 90 10 Haemophilus influenzae
Reagent, Haemophilus influenzae B antigen 17350 15 01 90 10 Haemophilus influenzae
Reagent, haptoglobin 17351 12 01 03 03 Haptoglobin
Reagent, hemopexin 17352 12 01 03 04 Haemopexin
Reagent, Hepatitis A antibody 17353 15 02 03 04 HCV Antibody (Total)
Reagent, Hepatitis A antibody-IgM specific 17354 15 02 03 06 HCV Antibody IgM
Reagent, Hepatitis B core antibody 17355 15 02 02 14 Hepatitis B Core Antibody (Total)
Reagent, hepatitis b core antibody-igm specific 17356 15 02 02 16 Hepatitis B Core Antibody IgM
Reagent, Hepatitis B core antigen 17357 15 02 02 11 Hepatitis B Core Antigen
Reagent, hepatitis Be antibody/antigen 17358 15 02 02 24 Hepatitis Be Antibody (Total)
Reagent, Hepatitis B surface antibody 17359 15 02 02 04 Hepatitis B Surface Antibody (Total)
Reagent, Hepatitis surface antigen 17360 15 02 02 01 Hepatitis B Surface Antigen
Reagent, hepatitis B surface antigen-confirmatory 17361 15 02 02 02 Hepatitis B Surface Antigen - Confirmatory
Reagent, Herpes simplex detection 17362 15 04 03 01 HSV Antigen
Reagent, Herpes simplex antibody 17363 15 04 03 04 HSV Antibodies - Total
Reagent, Herpes simplex antibody-IgM specific 17364 15 04 03 06 HSV IgM
Reagent, Histoplasma capsulatum antibody 17366 15 06 01 90 Other Mycology Immunoassays
Reagent, immunoglobulin A 17369 12 01 01 01 Immunoglobulin A

Page 14 of 108
Reagent, immunoglobulin D 17370 12 01 01 03 Immunoglobulin D

Reagent, immunoglobulin E 17371 12 02 01 02 Immunoglobulin E - Total
Reagent, immunoglobulin G 17372 12 01 01 05 Immunoglobulin G
Reagent, immunoglobulin M 17373 12 01 01 07 Immunoglobulin M
Reagent, properdin factor b 17374 12 01 02 90 Other Complement Components
Reagent, Proteus OX antibody 17375 15 01 90 12 Proteus
Reagent, rapid Streptococcus detection 17377 15 70 01 03 Strep A - Rapid Test
Reagent, retinol binding protein 17378 12 01 03 07 Retinol Binding Protein
Reagent, rheumatoid factor 17379 12 11 01 10 Rheumatoid Factors
Reagent, rickettsia antibody 17380 15 01 90 05 Rickettsia
Reagent, Rotavirus detection 17381 15 04 80 06 Rotavirus
Reagent, rubella virus antibody 17382 15 04 01 04 Rubella Virus Antibodies - Total
Reagent, rubella virus antibody-IgM specific 17383 15 04 01 06 Rubella Virus IgM
Reagent, salmonella antibody 17384 15 01 10 03 Salmonella Antibody Assays
Reagent, Staphylococcus aureus detection 17386 15 01 12 01 Staphylococcal Direct Antigen Detection
Reagent, Streptococcus detection 17388 15 01 11 01 Streptococcal Direct Antigen Detection
Reagent, Streptococcus group 17389 15 01 11 01 Streptococcal Direct Antigen Detection
Reagent, Streptococcus group A detection 17390 15 01 11 01 Streptococcal Direct Antigen Detection
Reagent, Streptococcus group B detection 17391 15 01 11 01 Streptococcal Direct Antigen Detection
Reagent, Streptococcus pneumoniae detection 17392 15 01 11 01 Streptococcal Direct Antigen Detection
Reagent, syphilis-reagin antibody 17393 15 01 03 03 Syphilis Antibody Assays Total
Reagent, syphilis-treponemal antibody 17394 15 01 03 03 Syphilis Antibody Assays Total
Reagent, syphilis-treponemal antibody/antigen 17395 15 01 03 03 Syphilis Antibody Assays Total
Reagent, thyroglobulin 17398 12 04 01 08 Thyroglobulin
Reagent, Toxoplasma gondii antibody 17400 15 05 01 04 Toxoplasma Antibody (Total)
Reagent, Toxoplasma gondii antibody-IgM specific 17401 15 05 01 06 Toxoplasma Antibody IgM
Reagent, transferrin 17402 12 01 03 08 Transferrin
Reagent, Trichinella spiralis antibody 17403 15 05 10 90 Other Parasitology
Reagent, Trichomonas species 17404 15 05 10 90 Other Parasitology
Reagent, varicella-zoster virus antibody 17405 15 04 80 10 Varicella Zoster
Reagent, yeast detection 17406 14 03 04 03 Identification Systems for Yeasts and Fungi - Automated
Reagent, occult blood, fecal 17410 12 03 90 04 Fecal Occult Blood (IC) CC =>11.70.03.01
Reagent, occult blood, gastric 17411 12 03 90 04 Fecal Occult Blood (IC) CC =>11.70.03.01
Reagent, strip, glucose 17419 11 70 01 01 Glucose Test Strips
Reagent, strip, multichemistry 17420 11 70 01 90 Other Blood Test Strips
Microscope, stereo 17439 00 00 00 00 Not for IVD use
Culture medium, enrichment, microbiological 17451 14 01 03 04 Enrichment media (Bottles)
Microcentrifuge 17452 28 01 10 01 SP Hardware + accessories + software
Analyser, laboratory, breath 17474 00 00 00 00 Not for IVD use
Analyser, point-of-care, breath, alcohol 17475 00 00 00 00 Not for IVD use

Page 15 of 108
Analyser, point-of-care, breath, hydrogen 17476 00 00 00 00 Not for IVD use

Reagent, strip, urinalysis 17480 11 70 02 02 Urine Multi-Constituent Test Strips
Reagent, urine, albumin 17607 12 01 03 01 Albumin (IC) incl. uAlbumin CC =>11.02.01.01
Analyser, physiologic, thermometric fertility cycle 17645 00 00 00 00 Not for IVD use
Reagent, strip, cholesterol 17656 11 70 01 02 Cholesterol Test Strips
Analyser, laboratory, haematology 17740 23 01 10 01 CC Hardware + dedicated accessories + software
Analyser, laboratory, haematology, cell counting, automated 17741 23 01 10 01 CC Hardware + dedicated accessories + software
Analyser, laboratory, haematology, cell counting, semiautomated 17742 23 01 10 01 CC Hardware + dedicated accessories + software
Reagent, Pneumocystis carinii 17778 14 05 02 01 Pneumocystis carinii
Reagent, Cryptosporidium 17779 15 05 10 07 Cryptosporidium
Reagent, Giardia lamblia 17780 15 05 10 08 Giardia lamblia
Microwave oven, plasma-thawing 17847 00 00 00 00 Not for IVD use
Holding media 17894 14 01 01 90 Other DCM
Reagent, Hepatitis C antibody 17914 15 02 03 04 HCV Antibody (Total)
Analyser, laboratory, immunoassay, chemiluminescent 17916 21 02 10 01 IC Hardware + dedicated accessories + software
Reagent, strip, alcohol 17941 11 70 01 90 Other Blood Test Strips
Detector, protective barrier strike-through 17994 00 00 00 00 Not for IVD use
Monitor, bedside, blood gas, transcutaneous 17996 00 00 00 00 Not for IVD use
Aqueous flare/cell meter 18102 00 00 00 00 Not for IVD use
Reagent, prostate-specific antigen (PSA) 18127 12 03 01 32 Total Prostatic Specific Antigen
Albumin kit 30155 11 02 01 01 Albumin (CC) IC =>12.01.03.01
Bile acid kit 30156 11 02 01 02 Bile acids
Bilirubin kit 30157 11 02 01 03 Bilirubin
Urea nitrogen kit 30158 11 02 01 04 Urea/Blood Urea Nitrogen
Cholesterol kit, total 30159 11 02 01 05 Cholesterol
Copper kit 30160 11 02 01 06 Copper
Creatinine kit 30161 11 02 01 07 Creatinine
D-xylose kit 30162 11 02 01 08 D-Xylose
Delta-aminolaevulinic acid kit 30163 11 02 01 09 Delta-Aminolaevulinic acid
Fructosamine kit 30164 11 02 01 10 Fructosamine
Fructose kit 30165 11 02 01 11 Fructose
Galactose kit 30166 11 02 01 12 Galactose
Glucose kit 30167 11 02 01 13 Glucose
Glycated haemoglobin kit 30168 11 02 01 14 Glycosylated/Glycated Haemoglobin IC=12.06.01.06
High density lipoprotein kit 30169 11 02 01 15 High Densitiy Lipoprotein Cholesterol
Cr iron, CC 30170 11 02 01 16 Iron (CC) IC =>12.07.01.04
Lactate kit 30171 11 02 01 18 Lactate
Lecithin/sphingomyelin kit 30172 11 02 01 19 Lecithin
Low density lipoprotein kit 30173 11 02 01 21 Low Density Lipoprotein Cholesterol
Non-esterified fatty acid kit 30174 11 02 01 22 Non Esterified Fatty Acids

Page 16 of 108
Oxalate kit 30175 11 02 01 23 Oxalate

Phospholipid kit 30176 11 02 01 24 Phospholipids
Porphobilinogen kit 30177 11 02 01 25 Porphobilinogen
Pyruvate kit 30178 11 02 01 26 Pyruvate
Total lipids kit 30179 11 02 01 28 Total Lipids
Total porphyrine kit 30180 11 02 01 29 Total Porphyrine
Total protein kit 30181 11 02 01 30 Total Protein
Triglyceride kit 30182 11 02 01 31 Triglycerides
Uric acid kit 30183 11 02 01 32 Uric Acid
Atomic absorption spectroscopy kit, zinc 30184 11 02 01 33 Zinc
Ammonia kit 30185 11 03 01 01 Ammonia
Bicarbonate kit 30186 11 03 01 02 Bicarbonate
Calcium kit 30187 11 03 01 03 Calcium
Chloride kit 30188 11 03 01 04 Chloride
Lithium kit 30189 11 03 01 06 Lithium
Magnesium kit 30190 11 03 01 07 Magnesium
Phosphorous/inorganic phosphate kit 30191 11 03 01 08 Phosphate inorganic / Phosphorus
Potassium kit 30192 11 03 01 09 Potassium
Sodium kit 30193 11 03 01 10 Sodium
Electrode, ion-selective, ammonia 30194 11 04 01 01 Ammonia - Electrodes
Electrode, ion-selective, calcium 30195 11 04 01 02 Calcium - Electrodes
Electrode, ion-selective, chloride 30196 11 04 01 03 Chloride - Electrodes
Electrode, ion-selective, lithium 30197 11 04 01 04 Lithium - Electrodes
Electrode, ion-selective, magnesium 30198 11 04 01 05 Magnesium - Electrodes
Electrode, ion-selective, potassium 30199 11 04 01 06 Potassium - Electrodes
Electrode, ion-selective, sodium 30200 11 04 01 07 Sodium - Electrodes
Electrode, ion-selective, carbon dioxide 30202 11 04 02 01 Carbon Dioxide - Electrodes
Electrode, pH, in vitro 30203 11 04 02 02 pH - Electrodes
Electrode, ion-selective, oxygen 30204 11 04 02 03 Oxygen - Electrodes
Electrode, ion-selective, creatinine 30205 11 04 03 01 Creatinine - Electrodes
Glucose electrode 30206 11 04 03 02 Glucose - Electrodes
Electrode, ion-selective, glycated haemoglobin 30207 11 04 03 03 Glycated Haemoglobin - Electrodes
Electrode, ion-selective, lactate 30208 11 04 03 04 Lactate - Electrodes
Electrode, ion-selective, urea 30209 11 04 03 05 Urea - Electrodes
Blood gas buffer/solution 30210 11 04 04 03 Blood Gas Buffers and Solutions
Assayed multicomponent serum kit, normal 30211 11 50 01 01 Assayed Multicomponent Sera (CC)
Assayed multicomponent serum kit, abnormal 30212 11 50 01 01 Assayed Multicomponent Sera (CC)
Enzyme control serum 30213 11 50 02 01 Enzyme Control Sera
Lipid control serum 30214 11 50 02 02 Lipid Control Sera
Bilirubin control 30215 11 50 02 03 Bilirubin Control Sera

Page 17 of 108
Clinical chemistry calibrator, multi-component 30216 11 50 03 01 Calibrators Multicomponent (CC)

Clinical chemistry calibrator, single-component 30217 11 50 03 02 Calibrators Single Component (CC)
Blood gas control 30218 11 50 90 01 Blood gas control
Urine control 30219 11 50 90 02 Urine Control
Cerebrospinal fluid control 30220 11 50 90 03 CSF controls
Blood glucose test strip 30221 11 70 01 01 Glucose Test Strips
Cholesterol test strip, total 30222 11 70 01 02 Cholesterol Test Strips
High density lipoprotein test strip 30223 11 70 01 03 HDL Test Strips
Lactate test strip 30224 11 70 01 04 Lactate Test Strips
Urine test strip, single constituent 30225 11 70 02 01 Urine Single Test Strips (incl. tablets)
Urine test strip, multiple constituent 30226 11 70 02 02 Urine Multi-Constituent Test Strips
Urine sediment test kit 30227 11 70 02 10 Urine SedimentTest Kit
Immunoglobulin A kit 30228 12 01 01 01 Immunoglobulin A
Immunoglobulin A subclass kit 30229 12 01 01 02 Immunoglobulin A subclass reagents
Immunoglobulin D kit 30230 12 01 01 03 Immunoglobulin D
Immunoglobulin D subclass kit 30231 12 01 01 04 Immunoglobulin D subclass reagents
Immunoglobulin G kit 30232 12 01 01 05 Immunoglobulin G
Immunoglobulin G subclass kit 30233 12 01 01 06 Immunoglobulin G subclass reagents
Immunoglobulin M kit 30234 12 01 01 07 Immunoglobulin M
Immunoglobulin M subclass kit 30235 12 01 01 08 Immunoglobulin M subclass reagents
Kappa/lambda chain kit 30236 12 01 01 20 Kappa and Lambda chain
Antihuman immunoglobulin polyvalent antiserum kit 30237 12 01 01 40 Anti Human Ig polyvalent antisera
Human anti-mouse antibody kit 30238 12 01 01 50 Human anti-mouse antibody
Complement component C1q kit 30239 12 01 02 01 Complement Component C1q
Complement component C1 inactivator kit 30240 12 01 02 02 Complement Component C1 inactivator
Complement component C3/C3c kit 30241 12 01 02 03 Complement Component C3/C3c
Complement component Bb kit 30242 12 01 02 04 Complement Component for Bb
Complement component C4 kit 30243 12 01 02 05 Complement Component C4
Complement component C5a kit 30244 12 01 02 06 Complement Component C5a
Complement component C5-9 kit 30245 12 01 02 07 Complement Component C5-9
Albumin, immunochemistry 30246 12 01 03 01 Albumin (IC) incl. uAlbumin CC =>11.02.01.01
Ceruloplasmin kit 30247 12 01 03 02 Ceruloplasmin
Haptoglobin kit 30248 12 01 03 03 Haptoglobin
Haemopexin kit 30249 12 01 03 04 Haemopexin
Lactoferrin kit 30250 12 01 03 05 Lactoferrin
Prealbumin/transthyretin kit 30251 12 01 03 06 Pre-albumin / Transthyretin
Retinol binding protein kit 30252 12 01 03 07 Retinol Binding Protein
Transferrin kit 30253 12 01 03 08 Transferrin
Transcobalamin S kit 30254 12 01 03 09 Transcobalamin (S)
Lipoprotein kit 30255 11 02 01 20 Lipoprotein, Chemical determination/detection

Page 18 of 108
Apolipoprotein A-I kit 30256 12 01 04 01 Apolipoprotein A I

Apolipoprotein A-II kit 30257 12 01 04 02 Apolipoprotein A II
Apolipoprotein B kit 30258 12 01 04 03 Apolipoprotein B
Apolipoprotein E genotyping kit 30259 12 01 04 11 Apolipoprotein E Genotyping Sub-typing GT=>16 01 02 03 00
Atrial natriuretic peptide kit 30260 12 13 01 01 Atrial- Brain Natriuric Peptide (incl. Pro-ANP/BNP)
Creatine kinase-myoglobin kit 30261 12 70 13 01 CK - MB / Myoglobin - Rapid Test
Fatty acid binding protein (FABP) kit 30262 12 13 01 03 Fatty Acid Binding Protein
Glycogen phosphorylase BB kit 30263 12 13 01 04 Glycogen Phosphorylase BB
Myoglobin kit 30264 12 13 01 05 Myoglobin
Myosin light chain kit 30265 12 13 01 06 Myosin Light Chain
Troponin kit 30266 12 13 01 07 Troponin (T + I)
a1-acid glycoprotein 30267 12 01 90 01 a1-Acid Glycoprotein ( Orosomucoid )
Alpha1-antitrypsin kit 30268 12 01 90 02 a1-Antitrypsin ( Protease inhibitor )
Alpha2-macroglobulin kit 30269 12 01 90 03 a2-Macroglobulin
Alpha1-microglobulin kit 30270 12 01 90 04 a1-Microglobulin
Fibronectin kit 30271 12 01 90 05 Fibronectin
Trypsin kit 30272 12 01 90 07 Trypsin (IC) CC =>11.01.01.30
Neonatal trypsin kit 30273 12 01 90 08 Trypsin Neonatal
Antihistamine antibody kit 30274 12 10 90 90 Other Other Auto-Immune Disease Tests
Immunoglobulin E kit 30275 12 02 01 02 Immunoglobulin E - Total
Immunoglobulin E specific, monotest/monoresult 30276 12 02 01 03 Immunoglobulin E - Specific, monotest/monoresult
Immunoglobulin E monotest/monoresult multiantigen kit 30277 12 02 01 04 Immunoglobulin E - monotest/monoresult - multi Ag
Immunoglobulin E monotest/pluriresult multiantigen kit 30278 12 02 01 05 Immunoglobulin E - monotest/pluriresult-multi Ag
Cancer antigen 15-3 kit 30279 12 03 01 02 Cancer Antigen 15-3
Cancer antigen 50 kit 30281 12 03 01 04 Cancer Antigen 50
Cytokeratin fragment 19 kit 30287 12 03 01 20 CYFRA 21-1
Carcinoembryonic antigen kit 30288 12 03 01 31 Carcinoembryonic Antigen
Mucin-like carcinoma-associated antigen kit 30289 12 03 01 90 Other Cancer Antigens
Prostatic specific antigen 30290 12 03 01 32 Total Prostatic Specific Antigen
Squamous cell carcinoma antigen kit 30291 12 03 01 35 Squamous Cell Carcinoma Antigen
Tissue polypeptide antigen kit 30292 12 03 01 36 Tumor Polypeptide Antigen (TPA - incl. TPS)
Oestrogen receptor kit 30293 12 03 02 01 Estrogen Receptor Assays
Progesterone receptor kit 30294 12 03 02 02 Progesterone Receptor Assays
Alphafoetoprotein kit 30295 12 03 90 01 Alphafetoprotein

Page 19 of 108
Beta2-microglobulin kit 30296 12 03 90 02 Beta2-Microglobulin

Cathepsin-D kit 30297 12 03 90 03 Cathepsin-D
5-hydroxyindoleacetic acid kit 30298 12 03 90 05 5 HIAA
Human placental alkaline phosphatase kit 30299 12 03 90 06 Human Placenta Like Alkaline Phosphatase
Laminin kit 30300 12 03 90 07 Laminin
Neuron specific enolase kit 30301 12 03 90 08 Neuron Specific Enolase
Oncogene deoxyribonucleic acid probe kit 30302 12 03 90 90 Other Other Tumour Markers
Oncogene protein kit 30303 12 03 90 90 Other Other Tumour Markers
Prostatic acid phosphatase, IC 30304 12 03 01 37 Prostatic Acid Phosphatase (IC) CC =>11.01.01.02
Thymidine kinase kit 30305 12 03 90 12 Thymidine Kinase
Tissue-associated protein kit 30306 12 03 90 13 Tissue Associated Protein
TPS 30307 12 03 01 36 Tumor Polypeptide Antigen (TPA - incl. TPS)
Free triiodothyronine kit 30308 12 04 01 01 Free Triiodothyronine
Free thyroxine kit 30309 12 04 01 02 Free Thyroxine
Neonatal thyroid stimulating hormone kit 30310 12 04 01 03 Neonatal Thyroid Stimulating Hormone
Reverse triiodothyronine kit 30311 12 04 01 04 Reverse Triiodothyronine
Triiodothyronine kit 30312 12 04 01 05 Triiodothyronine
Triiodothyronine uptake kit 30313 12 04 01 06 T- Uptake
Thyroxine kit 30314 12 04 01 07 Thyroxine
Thyroglobulin kit 30315 12 04 01 08 Thyroglobulin
Thyroxine binding globulin kit 30316 12 04 01 09 Thyroid binding globulin
Thyroid peroxydase antibody kit 30317 12 10 03 01 Thyroid Peroxidase (incl. Microsomal) Antibodies
Thyroid stimulating hormone kit 30318 12 04 01 11 Thyroid Stimulating Hormone
Androstenedione kit 30319 12 05 01 01 Androstenedione
Dehydroepiandrosterone kit 30320 12 05 01 02 Dehydro-epiandrosterone Sulphate (incl. DHEA)
Oestradiol kit 30321 12 05 01 03 Estradiol
Follicle stimulating hormone kit 30322 12 05 01 04 Follicle Stimulating Hormone
Progesterone kit 30323 12 05 01 06 Progesterone
17-hydroxyprogesterone kit 30324 12 05 01 07 17 OH Progesterone
Prolactin kit 30325 12 05 01 08 Prolactin
Sex hormone binding globulin kit 30326 12 05 01 09 Sex Hormone Binding Globulin
Testosterone kit 30327 12 05 01 10 Testosterone (with Dehydro and Free Testosterone)
Alpha2-pregnancy-associated glycoprotein kit 30328 12 05 02 01 Alpha2-Pregnancy Associated Glycoprotein
Oestriol kit 30329 12 05 02 02 Estriol
Free oestriol kit 30330 12 05 02 03 Unconjugated (free) Estriol
Oestrone kit 30331 12 05 02 04 Estrone
Total human chorionic gonadotrophin kit 30332 12 05 02 05 Human Chorionic Gonadotropin Total
Beta-human chorionic gonadotropin kit 30333 12 05 02 06 ß Human Chorionic Gonadotropin (incl. subunit)
Human placental lactogen kit 30334 12 05 02 07 Human Placental Lactogen
Pregnancy specific B1 glycoprotein kit 30335 12 05 02 08 Pregnancy Specific B1 -glycoprotein

Page 20 of 108
C-peptide kit 30336 12 06 01 01 C-Peptide

Glucagon kit 30337 12 06 01 02 Glucagon
Insulin kit 30338 12 06 01 03 Insulin
Insulin antibody kit 30339 12 06 01 04 Insulin Antibodies
Glutamic acid decarboxylase II antibody/islet cell antibody kit 30340 12 06 01 05 GAD II Antibodies and other ICA
Bone alkaline phosphate, IC 30341 12 06 03 01 Bone Alkaline Phosphatase (IC) CC =>11.01.01.06 iso-AP
Calcitonin kit 30342 12 06 03 02 Calcitonin
Collagen type I C-terminal propeptide kit 30343 12 06 03 03 Collagen Type I C-terminal Propeptide
Collagen type III C-terminal propeptide kit 30344 12 06 03 04 Collagen Type III C-terminal Propeptide
Cross-linked C-telopeptide kit 30345 12 06 03 05 Cross-Linked C-Telopeptides
Cross-linked N-telopeptide kit 30346 12 06 03 06 Cross-Linked N-Telopeptides
Cyclic adenosine monophosphate kit 30347 12 06 03 07 Cyclic Adenosin Monophosphate
Deoxypyridinoline kit 30348 12 06 03 08 Deoxypyridinoline
Vitamin D kit, 1-25-dihydroxyvitamin D3 30349 12 06 03 09 1.25 Dihydroxyvitamin D3
Vitamin D kit, 25-hydroxyvitamin D3 30350 12 06 03 10 25-Hydroxyvitamin D3
Hydroxyproline kit 30351 12 06 03 11 Hydroxyproline
Osteocalcine kit 30352 12 06 03 12 Osteocalcine
Parathyroid hormone intact kit 30353 12 06 03 13 Parathyroid Hormone intact
Parathyroid hormone fragment kit 30354 12 06 03 14 Parathyroid Hormone (C-/N-terminal, M-regional)
Parathyroid hormone-related peptide kit 30355 12 06 03 15 Parathyroid Hormone related Peptide
Pyridinoline kit 30356 12 06 03 16 Pyridinoline
Adrenocorticotropic hormone kit 30357 12 06 04 01 Adrenocortiotropic Hormone
Human growth hormone kit 30358 12 06 04 02 Human Growth Hormone
Insulin-like growth factor I kit 30359 12 06 04 03 Insulin-like Growth Factor I (Somatomedin C)
Insulin-like growth factor II kit 30360 12 06 04 04 Insulin-like Growth Factor II
Insulin-like growth factor binding protein 1 kit 30361 12 06 04 05 Insulin-like Growth Factor Binding Protein 1
Insulin-like growth factor binding protein 3 kit 30362 12 06 04 06 Insulin-like Growth Factor Binding Protein 3
Vasointestinal peptide kit 30363 12 06 04 07 Vasointestinal Peptide
Vasopressin kit 30364 12 06 04 08 Vasopressin
Bombesin kit 30365 12 06 05 01 Bombesin
Beta-endorphin kit 30366 12 06 05 02 ß-Endorphin
17-hydroxyketosterone kit 30367 12 06 05 03 17-Hydroxy-Ketosterone
17-ketogenic steroid kit 30368 12 06 05 04 17-Ketogenic Steroids
17-ketosteroid kit 30369 12 06 05 05 17-Ketosteroids
Melatonine kit 30370 12 06 90 06 Melatonine
Neopterine kit 30371 12 06 90 07 Neopterine
Oxytocin kit 30372 12 06 90 08 Oxytocin
Pepsinogen kit 30373 12 06 90 09 Pepsinogen
Prostaglandin kit 30374 12 06 90 10 Prostaglandin
Serotonin uptake, platelet 30375 12 06 90 11 Serotonin-Uptake (Platelets)

Page 21 of 108
Erythropoietin kit 30376 12 07 01 01 Erythropoietin

Ferritin kit 30377 12 07 01 02 Ferritin
Folate kit 30378 12 07 01 03 Folate
Iron kit 30379 12 07 01 04 Iron (IC) CC =>11.02.01.16
Iron binding capacity kit 30380 12 07 01 05 Iron Binding Capacity - Total (IC) CC =>11.02.01.17
Vitamin B1 kit 30381 12 07 02 01 Vitamin B1
Vitamin D kit, cholecalciferol 30385 12 06 03 10 25-Hydroxyvitamin D3
Digoxin kit 30386 12 08 01 01 Digoxin
Digitoxin kit 30387 12 08 01 02 Digitoxin
Disopyramide kit 30388 12 08 01 03 Disopyramide
Flecainide kit 30389 12 08 01 04 Flecainide
Lidocaine kit 30390 12 08 01 05 Lidocaine
N-acetylprocainamide kit 30391 12 08 01 06 N-Acetylprocainamide
Procainamide kit 30392 12 08 01 07 Procainamide
Propranolol kit 30393 12 08 01 08 Propranolol
Quinidine kit 30394 12 08 01 09 Quinidine
Carbamazepine kit 30395 12 08 02 01 Carbamazepine
Ethosuximide kit 30396 12 08 02 02 Ethosuximide
Free carbamazepine kit 30397 12 08 02 03 Free Carbamazepine
Free phenytoin kit 30398 12 08 02 04 Free Phenytoin
Free primodine kit 30399 12 08 02 05 Free Primodine
Free valproic acid kit 30400 12 08 02 06 Free Valproic Acid
Phenobarbital kit 30401 12 08 02 07 Phenobarbital
Phenytoin kit 30402 12 08 02 08 Phenytoin
Primidone kit 30403 12 08 02 09 Primidone
Valproic acid kit 30404 12 08 02 10 Valproic Acid
Amikacin kit 30405 12 08 03 01 Amikacin
Chloramphenicol kit 30406 12 08 03 02 Chloramphenicol
Dibekacin kit 30407 12 08 03 03 Dibekacin
Gentamicin kit 30408 12 08 03 04 Gentamicin
Kanamycin kit 30409 12 08 03 05 Kanamycin
Netilmicin kit 30410 12 08 03 06 Netilmycin
Sisomycin kit 30411 12 08 03 07 Sisomycin
Streptomycin kit 30412 12 08 03 08 Streptomycin
Tobramycin kit 30413 12 08 03 09 Tobramycin
Vancomycin kit 30414 12 08 03 10 Vancomycin
Teicoplanine kit 30415 12 08 03 11 Teicoplanine

Page 22 of 108
Caffeine kit 30416 12 08 04 01 Caffeine

Theophylline kit 30417 12 08 04 02 Theophylline
Methotrexate kit 30418 12 08 05 01 Methotrexate
Cyclosporine kit 30419 12 08 06 01 Cyclosporine Total
Cyclosporine specific 30420 12 08 06 02 Cyclosporine Specific
Tacrolimus kit 30421 12 08 06 03 Tacrolimus
Amphetamine kit 30422 12 09 01 01 Amphetamines Group
Amphetamine/methamphetamine specific +ecstasy 30423 12 09 01 02 Amphetamine/Methamphetamine Specific (+Ecstasy)
Barbiturate kit 30424 12 09 01 03 Barbiturates
Benzodiazepine kit 30425 12 09 01 04 Benzodiazepines
Cannabinoid kit 30426 12 09 01 05 Cannabinoids
Cocaine/cocaine metabolite kit 30427 12 09 01 06 Cocaine + Cocaine Metabolites
Codeine kit 30428 12 09 01 07 Codeine
Cotinine/nocotine/nicotine kit 30429 12 09 01 08 Cotinine
Lysergic acid diethylamide kit 30430 12 09 01 09 Lysergic acid diethylamide
Methadone kit 30431 12 09 01 10 Methadone
Methaqualone kit 30432 12 09 01 11 Methaqualone
Morphine kit 30433 12 09 01 12 Morphines
Opiate kit 30434 12 09 01 13 Opiates
Phencyclidine kit 30435 12 09 01 14 Phencyclidine
Propoxyphene kit 30436 12 09 01 15 Propoxyphene
Acetaminophene kit 30437 12 09 02 01 Acetaminophene (Paracetamol)
5-aminolevulinate dehydratase kit 30438 12 09 02 02 5-Aminolevulinate Dehydratase
Amitriptyline kit 30439 12 09 02 03 Amitriptyline
Catecholamine kit 30440 12 09 02 04 Catecholamines
Desipramine kit 30441 12 09 02 05 Desipramine
Doxepin/doxepin metabolite kit 30442 12 09 02 06 Doxepin plus metabolites
Alcohol kit 30443 12 09 02 07 Ethanol (Alcohol)
Hippuric acid kit 30444 12 09 02 08 Hippuric Acid
Imipramine kit 30445 12 09 02 09 Imipramine
Nortriptyline kit 30446 12 09 02 10 Nortriptyline
Phenol kit 30447 12 09 02 11 Phenols
Protoporphyrin kit 30448 12 09 02 12 Protoporphyrin IX
Salicylate kit 30449 12 09 02 13 Salicylate
Trichloroacetic acid kit 30450 12 09 02 14 Trichloroacetic Acid
Tricyclic antidepressant kit 30451 12 09 02 15 Tricyclic Antidepressants (Total)
Uro/coproporphyrin kit 30452 12 09 02 16 Uro/Coproporphyrins
Vanilmandelic acid kit 30453 12 09 02 17 Vanillylmandelic Acid
Antinuclear antibody kit 30454 12 10 01 01 ANA Screening
Extractable nuclear antigen kit 30455 12 10 01 02 ENA Screening

Page 23 of 108
Anticytoplasmic antibody kit 30456 12 10 01 03 Anti cytoplasmic - Antibodies

CENP-antibody kit 30457 12 10 01 04 CENP - Antibodies
ds DNA, antibodies 30458 12 10 01 05 ds DNA - Antibodies
ss DNA, antibodies 30459 12 10 01 06 ss DNA - Antibodies
Histone kit 30460 12 10 01 07 Histones (H1,H2a,H3,H4,…Hn)
Jo-1 antibody kit 30461 12 10 01 08 Jo-1
Polymyositis-scleroderma antibody kit 30462 12 10 01 09 PM-Scl - Antibodies
Scleroderma-70 antibody kit 30463 12 10 01 10 Scl-70
U1-small nuclear ribonucleoprotein antibody kit 30464 12 10 01 14 U1-snRNP - Antibodies
Antiganglioside total antibody kit 30465 12 10 02 01 Anti-Ganglioside-Antibodies Total
Anti-GM1 antibody kit 30466 12 10 02 02 Anti-GM1
Asialo-GM1 kit 30467 12 10 02 03 Asialo-GM1
Anti-GD1b antibody kit 30468 12 10 02 04 Anti-GD1b
GalNAc kit 30469 12 10 02 06 GalNAc
Antimyelin-associated glycoprotein kit 30470 12 10 02 07 Anti-MAG (Myelin Associated Glycoprotein)
Anti-cancer associated retinopathy kit 30471 12 10 02 08 Anti-CAR (Cancer Associated Retinopathy)
Anti-Hu antibody kit 30472 12 10 02 09 Anti-Hu Antibody
Anti-Yo blood group antibody kit 30473 12 10 02 10 Anti-Yo Antibody
Anti-Ri antibody kit 30474 12 10 02 11 Anti-Ri Antibody
Anticardiolipin antibody kit 30475 12 10 90 01 Anti-Cardiolipin Antibodies
Antimitochondrial antibody kit 30476 12 10 90 02 Anti-Mitochondrial Antibodies
Antiphosphatidylserine antibody kit 30477 12 10 90 03 Anti-Phosphatidylserin Antibodies
Anti-B2-glycoprotein I antibody kit 30478 12 10 90 04 Anti-ß2-Glycoprotein I Antibodies
Complement component C3b activation kit 30479 12 10 90 05 Complement Activation
Gliadin antibody kit 30480 12 10 90 06 Gliadin Antibodies
Goodpasture antibody kit 30481 12 10 90 07 Goodpasture Antibodies
Liver-kidney microsome 1/related protein antibody kit 30482 12 10 90 08 LKM1 and Related Proteins Antibodies
Myeloperoxidase antineutrophil cytoplasmic autoantibody kit 30483 12 10 90 09 MPO ANCA
Proteinase 3-antineutrophil cytoplasmic autoantibody kit 30484 12 10 90 10 PR3 ANCA
Parietal cell antibody kit 30485 12 10 90 11 Parietal Cell Antibodies
Sperm antibody kit 30486 12 10 90 13 Sperm Antibodies
Systemic lupus erythematosis kit 30487 12 10 01 16 Systemic Lupus Erythematosus
Thyroid microsomal antibody kit 30488 12 10 03 01 Thyroid Peroxidase (incl. Microsomal) Antibodies
Thyroid stimulating hormone receptor antibody kit 30489 12 10 03 03 TSH Receptor Antibodies
Thyroglobulin autoantibody kit 30490 12 10 03 04 Thyroglobulin Autoantibodies
Antistreptococcal Dnase B kit 30491 12 11 01 01 Anti-Streptococcal D Nase B
Antistreptococcal hyaluronidase kit 30492 12 11 01 02 Anti-Streptococcal Hyaluronidase
Antistreptokinase antibody kit 30493 12 11 01 03 Anti-Streptokinase (ASK)
Anti-streptolysin reaction/titre, quantitative 30494 12 11 01 04 Anti-Streptolysin (quantitative)
Anti-streptolysin/anti-streptolysin O, qualitative 30495 12 11 01 05 Anti-Streptolysin/Anti-Streptolysin O (qualitative)

Page 24 of 108
Anti-staphylolysin reaction, quantitative 30496 12 11 01 06 Anti-Staphylolysin (qualititative)

Anti-staphylolysin, qualitative 30497 12 11 01 07 Anti-Staphylolysin (qualitative)
Circulating immune complex kit 30498 12 11 01 08 Circulating Immune Complexes
C-reactive protein kit 30499 12 11 01 09 C-Reactive Protein IC=> 12 70 11 01
Rheumatoid factor kit 30500 12 11 01 10 Rheumatoid Factors
Monoethylglycinexylidide kit 30501 12 12 01 01 MEGX
Drug calibrator 30502 12 50 01 01 TDM/Drug Standards / Calibrators
Drug control 30503 12 50 01 02 TDM/Drug Controls
Hormone calibrator 30504 12 50 01 03 Hormone Standards / Calibrators
Plasma protein calibrator 30505 12 50 01 05 Specific Protein Standards / Calibrators
Plasma protein control 30506 12 50 01 06 Specific Protein Controls
CK-MB/myoglobin rapid test 30507 12 70 13 01 CK - MB / Myoglobin - Rapid Test
Myoglobin rapid test 30508 12 70 13 02 Myoglobin - Rapid Test
Troponin T rapid test 30509 12 70 13 03 Troponin I/T - Rapid Test
Bladder tissue antigen kit 30510 12 03 01 01 Bladder Tissue Antigen
PSA rapid test 30511 12 70 03 11 PSA - Rapid Test
FSH rapid test 30512 12 70 05 01 FSH - Rapid Test
HCG rapid test 30513 12 70 05 02 HCG - Rapid Test
HPL rapid test 30514 12 70 05 03 HPL - Rapid Test
Luteinizing hormone self-testing device 30515 12 70 05 04 LH - Rapid Test
Amphetamine rapid test 30516 12 70 09 01 Amphetamines Group - Rapid Test
Barbiturate rapid test 30517 12 70 09 03 Barbiturates - Rapid Test
Benzodiazepine rapid test 30518 12 70 09 04 Benzodiazepines - Rapid Test
Cannabinoid rapid test 30519 12 70 09 05 Cannabinoids - Rapid Test
Cocaine/cocaine metabolite rapid test 30520 12 70 09 06 Cocaine + Cocaine Metabolites - Rapid Test
Methadone rapid test 30521 12 70 09 07 Methadone - Rapid Test
Opiate rapid test 30522 12 70 09 08 Opiates - Rapid Test
Phencyclidine rapid test 30523 12 70 09 09 Phencyclidine - Rapid Test
Tricyclic antidepressant rapid test 30524 12 70 09 10 Tricyclic Antidepressants - Rapid Test
Amanitin kit 30525 12 90 01 02 Amanitin ( Organic poisons )
Reticulocyte kit 30526 13 01 01 10 Specific Reticulocyte reagents
Haemoglobin subtype kit 30527 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
Haematology stain for microscopy 30528 13 01 03 01 Histo/Cyto stains
Cellular enzyme determination kit 30529 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Glandular fever kit 30530 13 01 09 02 Glandula fever
Haematology control/calibrator 30531 13 01 20 Haematology Controls and Calibrators
Control blood normal 30532 13 01 20 01 Control Blood Normal
Control blood abnormal 30533 13 01 20 02 Control Blood Abnormal
Control bood multilevel 30534 13 01 20 03 Control Blood Multilevel
Haemoglobin kit 30535 13 01 02 01 Haemoglobin determinations (Total Hb)

Page 25 of 108
Platelet control 30536 13 01 20 05 Platelet Control

Reticulocyte control 30537 13 01 20 06 Reticulocyte Control
Whole blood calibrator 30538 13 01 20 07 Whole Blood Calibrators
Prothrombin time kit 30539 13 02 01 01 Prothrombin time ( Quick Test )
Thrombin time kit 30540 13 02 01 03 Thrombin Time / Reptilase / Batroxobin Time
Fibrinogen kit 30541 13 02 02 01 Fibrinogen Assays (Factor I)
Coagulation factor II kit 30542 13 02 02 02 Coagulation factor II ( Prothrombin )
Coagulation factor IIa kit 30543 13 02 02 03 Coagulation factor II a ( Thrombin )
Coagulation factor V kit 30544 13 02 02 04 Coagulation factor V
Coagulation factor VII kit 30545 13 02 02 05 Coagulation factor VII
Coagulation factor VIIa kit 30546 13 02 02 06 Coagulation factor VII a
Coagulation factor VIII kit 30547 13 02 02 07 Coagulation factor VIII
Coagulation factor IX kit 30548 13 02 02 08 Coagulation factor IX
Coagulation factor X kit 30549 13 02 02 09 Coagulation factor X
Coagulation factor II, VII, X kit 30550 13 02 02 90 Other Coagulation Factors
Coagulation factor XI kit 30551 13 02 02 11 Coagulation factor XI
Coagulation factor XII kit 30552 13 02 02 12 Coagulation factor XII
Coagulation factor XIIa kit 30553 13 02 02 13 Coagulation factor XII a
Coagulation factor XIII kit 30554 13 02 02 14 Coagulation factor XIII
Coagulation factor XIIIa kit 30555 13 02 02 90 Other Coagulation Factors
Coagulation factor XIIIs kit 30556 13 02 02 90 Other Coagulation Factors
Coagulation factor high molecular weight (HMW) kininogen kit 30557 13 02 02 17 Coagulation factor HMW-Kininogen (Fitzgerald)
Coagulation factor von Willebrand kit 30558 13 02 02 18 Coagulation factor von Willebrand Antigen
Prekallikrein/kallikrein kit 30559 13 02 02 19 Prekallikrein / Kallikrein (Fletcher factor)
Activated protein C resistance kit 30560 13 02 06 11 APC Resistance
Factor V Leiden kit 30561 13 02 02 04 Coagulation factor V
Fibrin sensitivity monomer kit 30562 13 02 03 03 Fibrin sensitivity monomer
Fibrinopeptide A kit 30563 13 02 03 04 Fibrinopeptide A
Heparin kit 30564 13 02 03 05 Heparin
Hirudin test kit 30565 13 02 03 06 Hirudin Test
Plasmin-alpha2-antiplasmin complex kit 30566 13 02 03 07 Plasmin - a2 - Antiplasmin Complex
Prothrombin fragment 1+2 kit 30567 13 02 03 08 Prothrombin Fragment 1 + 2
Thrombin-antithrombin III-complex kit 30568 13 02 03 09 Thrombin-Antithrombin III-Complex
Aggregation reagents 30569 13 02 04 01 Aggregation Factors
Platelet factor 4 kit 30570 13 02 04 02 Platelet Factor 4
Prostacyclin kit 30571 13 02 04 03 Prostacyclin
Thromboxane kit 30572 13 02 04 04 Thromboxane
Beta-thromboglobulin kit 30573 13 02 04 05 ß-Thromboglobulin
Alpha2-antiplasmin kit 30574 13 02 05 01 a2-Antiplasmin
Fibrinogen degradation product kit 30575 13 02 05 02 Fibrinogen Degradation Products

Page 26 of 108
D-dimer kit 30576 13 02 05 03 D-Dimer

Plasmin kit 30577 13 02 05 04 Plasmin
Plasminogen kit 30578 13 02 05 05 Plasminogen
Plasminogen activator inhibitor kit 30579 13 02 05 06 Plasminogen Activator-Inhibitors
Tissue plasminogen activator kit 30580 13 02 05 07 Tissue Plasminogen Activator
Urokinase plasminogen activator kit 30581 13 02 05 08 Urokinase Plasminogen Activator
Antiphospholipid antibody kit 30582 13 02 06 01 Anti-Phospholipid Antibodies
Antithrombin III kit 30583 13 02 06 02 Antithrombin III
Coagulation factor VIII inhibitor kit 30584 13 02 06 04 Coagulation factor VIII Inhibitor
Coagulation factor IX inhibitor kit 30585 13 02 06 05 Coagulation factor IX Inhibitor
Coagulation factor X inhibitor kit 30586 13 02 06 06 Coagulation factor X Inhibitor
Lupus anticoagulant kit 30587 13 02 06 07 Lupus Anticoagulant Markers
Protein C kit 30588 13 02 06 08 Protein C
Protein S kit 30589 13 02 06 09 Protein S
Plasma control 30590 13 02 50 02 Control Plasmas
Prothrombin time rapid test 30591 13 02 70 01 Prothrombin Time Rapid Test
Calcium chloride 30593 13 02 80 01 Calcium Chloride
Citrate test 30594 14 90 90 90 Other Other Microbiology Tests
Haemostasis buffer kit 30595 13 02 80 03 Buffers (Haemostasis)
ABO grouping cell kit 30596 13 03 01 01 ABO grouping cells
ABO serum kit 30597 13 03 01 02 ABO sera
Rhesus phenotype kit 30598 13 03 02 02 Rhesus Phenotypes
Blood group antibody 2 cell screening kit 30599 13 03 04 01 Antibody 2 cell screening
Antibody 3 cell screening kit 30600 13 03 04 02 Antibody 3 cell screening
Antibody identification cell panel kit 30601 13 03 04 03 Antibody identification cell panels
Polyspecific antihuman serum kit 30602 13 03 04 04 Polyspecific antihuman serum
Monospecific antihuman serum kit 30603 13 03 04 05 Monospecific antihuman serum
Coombs control 30604 13 03 20 01 Coombs Control Cells
Immunohaematology control kit 30605 13 03 20 Immunohaematology Controls
Complement for HLA testing kit 30606 13 04 01 01 Complement for HLA testing
Human leukocyte antigen antibody screening kit 30607 13 04 01 02 HLA Antibody screening
Human leukocyte antigen typing kit 30608 13 04 01 03 HLA Antigen typing
Human leukocyte antigen control cells kit 30609 13 04 01 04 HLA Control Cells
Human leukocyte antigen nucleic acid kit 30610 13 04 01 90 Other Tissue Typing Reagents
B/T-cell subtyping antibody kit 30611 13 05 01 01 Antibodies for B and T-cell subtyping
Human leukocyte antigen class II determinant antibody kit 30612 13 05 01 02 Antibodies for HLA class II determinants
Lymphoma subtyping antibody kit 30613 13 05 01 03 Antibodies for lymphoma typing(except B-&T-cell typing)
Cell surface receptor recognizing antibody kit 30614 13 05 01 04 Antibodies for recognizing cell surface receptors
Leukaemia subtyping antibody kit 30615 13 05 01 05 Antibodies for subtyping of leukemia(except B-&T-cell typing)
Lymphocyte subtyping antibody kit 30616 13 05 01 06 Antibodies for Lymphocyte subtyping

Page 27 of 108
Interferon a/B/y kit 30617 13 06 01 01 Interferons (a,b,y)

Interleukin IL-1/IL-12 kit 30618 13 06 01 11 Interleukins (IL-1,IL-1A,IL-1B,.. - IL-15)
Interleukin IL-1a/IL1b/IL1RA/IL2r/IL6r kit 30619 13 06 01 12 Interleukins Receptors(IL-2R,IL6R ...)
Tumour necrosis factor kit 30620 13 06 01 04 Tumour Necrosis Factors (TNFa,TNFb)
Chromosome culture kit 30621 13 07 01 01 Chromosome Culture Kits / reagents
Cytochemical staining reagent 30622 13 07 01 02 Cytochemical staining reagents
Deoxyribonucleic acid in situ hybridization kit 30623 13 07 01 03 DNA in situ Hybridisation reagents
Embedding medium 30624 13 07 01 04 Embedding media (Histology/Cytology)
Mounting medium, <specify> 30625 13 07 01 06 Mounting media (Histology/Cytology)
Stain powder, histology/cytology 30626 13 07 01 07 Stain powders (Histology/Cytology)
Stain solution, histology/cytology 30627 13 07 01 08 Stain solutions (Histology/Cytology)
Immunohistologic kit 30628 13 07 01 11 Immunohistology kits
Dehydrated culture medium, bacteriology 30629 14 01 01 Dehydrated Culture Media (Bacteriology)
DCM 30630 14 01 01 01 DCM (except susceptibility testing)
Susceptibility testing media, bacteriology, dehydrated 30631 14 02 05 Susceptibility Testing - Manual
DCM additive 30632 14 01 01 04 Additives for DCM
Prepared media in tubes, bacteriology 30633 14 01 02 Prepared Media in Tubes (Bacteriology)
Broth medium, tube 30634 14 01 02 01 Broth Media (Tubes)
Culture medium, Mycobacterium isolation 30635 14 01 02 10 Mycobacteria Isolation Media (Tubes)
Transport medium, tube 30636 14 01 02 20 Transport Media (Tubes)
Prepared media in bottles, bacteriology 30637 14 01 03 Prepared Media in Bottles (Bacteriology)
Agar medium for pouring, bottle 30638 14 01 03 01 Agar Media for Pouring (Bottles)
Broth medium, bottle 30639 14 01 03 02 Broth Media (Bottles)
Enrichment medium, bottle 30640 14 01 03 04 Enrichment media (Bottles)
Mycobacterium medium, bottle 30641 14 01 03 10 Mycobacteria media (Bottles)
Culture medium, bacterial cultivation/identification 30642 14 01 01 Dehydrated Culture Media (Bacteriology)
Isolation medium, plate 30643 14 01 04 01 Isolation Media (Plates)
Substrate incorporated ID medium, plates 30644 14 01 04 02 Substrate Incorporated ID Media (Plates)
Susceptibility test medium, plate 30645 14 01 04 03 Susceptibility Test Media (Plates)
Blood culture, manual 30646 14 01 05 Blood Culture - Manual
Culture medium, blood, adult, automated 30647 14 01 06 01 Adult Bottles (Blood Culture -Autom.)
Urine screening system, automated 30648 14 01 07 01 Urine Screening Systems - Automated
Urine screening, manual, strip 30649 14 01 07 02 Urine Screening Manual (Strips etc.)
Gram's stain 30650 14 01 08 01 Gram's Stain
Enterobacteriaceae, automated 30651 14 02 01 01 Enterobacteriaceae - Automated
Biochemical identification kit, anaerobe, automated 30652 14 02 01 05 Anaerobes - Automated
Enterobacteriaceae, manual 30653 14 02 02 01 Enterobacteriaceae - Manual
Biochemical identification kit, anaerobe, manual 30654 14 02 02 05 Anaerobes - Manual
Staphylococcus kit 30656 14 02 03 03 Staphylococci
System, Mycoplasma (inc. combined with I.D.) 30657 14 02 04 04 Systems for Mycoplasma (inc. combined with I.D.)

Page 28 of 108
Mycobacterium susceptibility test kit 30658 14 02 05 04 Mycobacteria Susceptibility Testing

Dehydrated culture medium, mycology 30659 14 03 01 Dehydrated Culture Media (Mycology)
DCM for yeasts/fungi 30660 14 03 01 01 DCM for Yeasts and Fungi
Prepared medium in plates, mycology 30661 14 03 02 Prepared Media in Plates (Mycology)
PPM for yeast/fungi 30662 14 03 02 01 PPM for Yeasts and Fungi
Substrate incorporated medium for yeasts/fungi 30663 14 03 02 02 Substrate Incorporated Media for Yeasts and Fungi
Culture medium, yeast/fungal cultivation/identification 30664 14 03 04 03 Identification Systems for Yeasts and Fungi - Automated
Tubed/bottled medium for yeasts/fungi 30665 14 03 03 Tubes and Bottled Media for Yeasts and Fungi
Yeast kit 30666 14 03 04 01 Identification Systems for Yeasts - Manual
Analyser, yeast/fungi 30667 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Yeast/fungi nucleic acid kit 30668 15 06 01 90 Other Mycology Immunoassays
Serological identification, yeast/fungi 30669 14 03 05 01 Serological Identification of Yeasts and Fungi
Tissue culture cell 30670 14 04 01 01 Cells for Tissue Culture
Culture medium, tissue 30671 14 04 01 02 Media for Tissue Culture
Parasitology stain 30672 14 05 01 02 Parasitology Stains
Pneumocystis carinii kit 30673 14 05 02 01 Pneumocystis carinii
Plasmodium falciparum kit 30674 14 05 02 02 Plasmodium falciparum
Cryptosporidium kit 30675 14 05 02 03 Cryptosporidium
Chlamydia antigen kit 30676 15 01 01 01 Chlamydia Antigen Detection
Chlamydia nucleic acid kit 30677 15 01 01 40 Chlamydia Detection by NA Reagents
Chlamydia total antibody kit 30678 15 01 01 03 Chlamydia Antibody Assays Total
Chlamydia immunoglobulin A kit 30679 15 01 01 04 Chlamydia Antibody IgA
Chlamydia immunoglobulin G kit 30680 15 01 01 05 Chlamydia Antibody IgG
Chlamydia immunoglobulin M kit 30681 15 01 01 06 Chlamydia Antibody IgM
Gonococcus antigen kit 30682 15 01 02 01 Gonococcal Antigen Detection
Gonococcus nucleic acid kit 30683 15 01 02 40 Gonococci detection by NA Reagents
Gonococcus total antibody kit 30684 15 01 02 03 Gonococcal Antibody Assays Total
Treponema antigen kit 30685 15 01 03 01 Syphilis Antigen Detection
Treponema nucleic acid kit 30686 15 01 03 40 Syphilis detection by NA Reagents
Treponema total antibody kit 30687 15 01 03 03 Syphilis Antibody Assays Total
Treponema immunoglobulin G kit 30688 15 01 03 05 Syphilis Antibody IgG
Helicobacter pylori antigen kit 30689 15 01 04 01 H. Pylori Antigen Detection
Helicobacter pylori nucleic acid kit 30690 15 01 04 40 H. Pylori Detection by NA Reagents
Helicobacter pylori antibody kit 30691 15 01 04 03 H. Pylori Antibody Assays
Legionella antigen kit 30692 15 01 05 01 Legionella Antigen Detection
Legionella nucleic acid kit 30693 15 01 05 40 Legionella Detection by NA Reagents
Legionella antibody kit 30694 15 01 05 03 Legionella Antibody Assays
Borrelia antigen kit 30695 15 01 06 01 Lyme Antigen Detection
Borrelia nucleic acid kit 30696 15 01 06 40 Lyme Detection by NA Reagents
Borrelia total antibody kit 30697 15 01 06 03 Lyme Antibody Total

Page 29 of 108
Mycobacterium antigen kit 30698 15 01 07 01 Mycobacterial Antigen Detection

Mycobacterium nucleic acid kit 30699 15 01 07 40 Mycobacterial Detection by NA Reagents
Mycobacterium antibody kit 30700 15 01 07 03 Mycobacterial Antibody Assays
Mycoplasma 30701 15 01 08 Mycoplasma
Mycoplasma antigen kit 30702 15 01 08 01 Mycoplasma Antigen Detection
Mycoplasma nucleic acid kit 30703 15 01 08 40 Mycoplasma Detection by NA Reagents
Mycoplasma antibody kit 30704 15 01 08 03 Mycoplasma Antibody Assays
Pseudomonas kit 30705 15 01 90 13 Pseudomonas
Pseudomonas aeruginosa antibody IgG 30706 15 01 09 03 Pseudomonas Aeruginosa Antibody IgG
Salmonella antigen kit 30707 15 01 10 01 Salmonella Antigen Detection
Salmonella nucleic acid kit 30708 15 01 10 40 Salmonella Detection by NA Reagents
Salmonella antibody kit 30709 15 01 10 03 Salmonella Antibody Assays
Streptococcus antigen kit 30710 15 01 11 01 Streptococcal Direct Antigen Detection
Streptococcus nucleic acid kit 30711 15 01 11 40 Streptococci Detection by NA Reagents
Brucella kit 30713 15 01 90 01 Brucella
Clostridium difficile kit 30714 15 01 90 02 Clostridium difficile
Coxiella kit 30715 15 01 90 03 Coxiella
Leptospira kit 30716 15 01 90 04 Leptospira
Rickettsia kit 30717 15 01 90 05 Rickettsia
Yersinia kit 30718 15 01 90 06 Yersinia
Hepatitis A virus antigen confirmatory kit 30719 15 02 01 02 HAV Antigen Confirmatory
Hepatitis A virus total antibody kit 30720 15 02 01 04 HAV Antibody (Total)
Hepatitis A virus immunoglobulin G kit 30721 15 02 01 05 HAV Antibody IgG
Hepatitis A virus immunoglobulin M kit 30722 15 02 01 06 HAV Antibody IgM
Hepatitis B virus surface antigen kit 30723 15 02 02 01 Hepatitis B Surface Antigen
Hepatitis B virus surface antigen confirmatory kit 30724 15 02 02 02 Hepatitis B Surface Antigen - Confirmatory
Hepatitis B virus surface total antibody kit 30725 15 02 02 04 Hepatitis B Surface Antibody (Total)
Hepatitis B virus surface immunoglobulin G kit 30726 15 02 02 05 Hepatitis B Surface Antibody IgG
Hepatitis B virus surface immunoglobulin M kit 30727 15 02 02 06 Hepatitis B Surface Antibody IgM
Hepatitis B virus core antigen kit 30728 15 02 02 11 Hepatitis B Core Antigen
Hepatitis B virus core antigen confirmatory kit 30729 15 02 02 12 Hepatitis B Core Antigen - Confirmatory
Hepatitis B virus core nucleic acid kit 30730 15 02 02 40 Hepatitis B Virus - NA Reagents
Hepatitis B virus core total antibody kit 30731 15 02 02 14 Hepatitis B Core Antibody (Total)
Hepatitis B virus core immunoglobulin G kit 30732 15 02 02 15 Hepatitis B Core Antibody IgG
Hepatitis B virus core immunoglobulin M kit 30733 15 02 02 16 Hepatitis B Core Antibody IgM
Hepatitis B virus e antigen kit 30734 15 02 02 21 Hepatitis Be Antigen
Hepatitis B virus e antigen confirmatory kit 30735 15 02 02 22 Hepatitis Be Antigen - Confirmatory
Hepatitis B virus e antigen nucleic acid kit 30736 15 02 02 40 Hepatitis B Virus - NA Reagents
Hepatitis B virus e antigen total antibody kit 30737 15 02 02 24 Hepatitis Be Antibody (Total)
Hepatitis B virus e antibody immunoglobulin G kit 30738 15 02 02 25 Hepatitis Be Antibody IgG

Page 30 of 108
Hepatitis B virus e antibody immunoglobulin M kit 30739 15 02 02 26 Hepatitis Be Antibody IgM

Hepatitis C virus antigen kit 30740 15 02 03 01 HCV Antigen
Hepatitis C virus antigen confirmatory kit 30741 15 02 03 02 HCV Antigen - Confirmatory
Hepatitis C virus nucleic acid kit 30742 15 02 03 40 Hepatitis C Virus - NA Reagents
Hepatitis C virus total antibody kit 30743 15 02 03 04 HCV Antibody (Total)
Hepatitis C virus immunoglobulin G kit 30744 15 02 03 05 HCV Antibody IgG
Hepatitis C virus immunoglobulin M kit 30745 15 02 03 06 HCV Antibody IgM
Hepatitis C virus antibody confirmatory kit 30746 15 02 03 07 HCV Antibody - Confirmatory
Hepatitis D virus antigen kit 30747 15 02 04 01 Hepatitis Delta Antigen
Hepatitis D virus antigen confirmatory kit 30748 15 02 04 02 Hepatitis Delta Antigen - Confirmatory
Hepatitis D virus nucleic acid kit 30749 15 02 04 40 Hepatitis Delta Virus - NA Reagents
Hepatitis D virus total antibody kit 30750 15 02 04 04 Hepatitis Delta Antibody (Total)
Hepatitis D virus immunoglobulin G kit 30751 15 02 04 05 Hepatitis Delta Antibody IgG
Hepatitis D virus immunoglobulin M kit 30752 15 02 04 06 Hepatitis Delta Antibody IgM
Hepatitis E virus antigen kit 30753 15 02 05 01 HEV Antigen
Hepatitis E virus antigen confirmatory kit 30754 15 02 05 02 HEV Antigen - Confirmatory
Hepatitis E virus nucleic acid kit 30755 15 02 05 40 Hepatitis E Virus - NA Reagents
Hepatitis E virus total antibody kit 30756 15 02 05 04 HEV Antibody (Total)
Hepatitis E virus immunoglobulin G kit 30757 15 02 05 05 HEV Antibody IgG
Hepatitis E virus immunoglobulin M kit 30758 15 02 05 06 HEV Antibody IgM
Hepatitis G virus antigen kit 30759 15 02 07 01 HGV Antigen
Hepatitis G virus antigen confirmatory kit 30760 15 02 07 02 HGV Antigen - Confirmatory
Hepatitis G virus nucleic acid kit 30761 15 02 07 40 Hepatitis G Virus - NA Reagents
Hepatitis G virus total antibody kit 30762 15 02 07 04 HGV Antibody (Total)
Hepatitis G virus immunoglobulin G kit 30763 15 02 07 05 HGV Antibody IgG
Hepatitis G virus immunoglobulin M kit 30764 15 02 07 06 HGV Antibody IgM
Human immunodeficiency virus I antibody kit 30765 15 03 01 04 HIV 1 Antibody (Total)
Human immunodeficiency virus 1 antigen kit 30766 15 03 01 01 HIV 1 Antigen
Human immunodeficiency virus 1 antigen confirmatory kit 30767 15 03 01 02 HIV 1 Antigen - Confirmatory
Human immunodeficiency virus 1 nucleic acid kit 30768 15 03 01 40 HIV 1 - NA Reagents
Human immunodeficiency virus 1 total antibody kit 30769 15 03 01 04 HIV 1 Antibody (Total)
HIV 1 antibody IgG 30770 15 03 01 05 HIV 1 Antibody IgG
HIV 1 antibody IgM 30771 15 03 01 06 HIV 1 Antibody IgM
Human immunodeficiency virus 1 antibody confirmatory kit 30772 15 03 01 07 HIV 1 Antibody - Confirmatory
Human immunodeficiency virus 2 antibody kit 30773 15 03 02 04 HIV 2 Antibody
Human immunodeficiency virus 2 antibody confirmatory kit 30774 15 03 02 07 HIV 2 Antibody - Confirmatory
Human immunodeficiency virus 1 antigen p24 kit 30775 15 03 10 01 HIV P24 Antigen
Human immunodeficiency virus p24 antibody kit 30776 15 03 10 04 HIV P24 Antibody
HIV - multiple (1/2) 30777 15 03 20 HIV - Multiple ( 1 / 2 )
Human immunodeficiency virus multiple antigen kit 30778 15 03 20 01 HIV Multiple Antigen

Page 31 of 108
Human immunodeficiency virus multiple antibody kit 30779 15 03 20 04 HIV Multiple Antibody
Human immunodeficiency virus multiple antibody confirmatory kit 30780 15 03 20 07 HIV Multiple Antibody - Confirmatory
Human T-cell leukaemia virus I antigen kit 30781 15 03 30 01 HTLV I Antigen
Human T-cell leukaemia virus I nucleic acid kit 30782 15 03 30 40 HTLV I - NA Reagents
Human T-cell leukaemia virus I antibody kit 30783 15 03 30 04 HTLV I Antibody
Human T-cell leukaemia virus I antibody confirmatory kit 30784 15 03 30 07 HTLV I Antibody - Confirmatory
Human T-cell leukaemia virus II antigen kit 30785 15 03 31 01 HTLV II Antigen
Human T-cell leukaemia virus II nucleic acid kit 30786 15 03 31 40 HTLV II - NA Reagents
Human T-cell leukaemia virus II antibody kit 30787 15 03 31 04 HTLV II Antibody
Human T-cell leukaemia virus II antibody confirmatory kit 30788 15 03 31 07 HTLV II Antibody - Confirmatory
Human T-cell leukaemia virus multiple antigen kit 30789 15 03 40 01 HTLV Multiple Antigen
Human T-cell leukaemia virus multiple antigen nucleic acid kit 30790 15 03 40 40 HTLV Multiple - NA Reagents
Human T-cell leukaemia virus multiple antibody kit 30791 15 03 40 04 HTLV Multiple Antibody
Human T-cell leukaemia virus multiple antibody confirmatory kit 30792 15 03 40 07 HTLV Multiple Antibody - Confirmatory
Rubella virus nucleic acid kit 30793 15 04 01 40 Rubella - NA Reagents
Rubella virus total antibody kit 30794 15 04 01 04 Rubella Virus Antibodies - Total
Rubella virus immunoglobulin M kit 30795 15 04 01 05 Rubella Virus IgG
Rubella virus immunoglobulin G kit 30796 15 04 01 06 Rubella Virus IgM
Cytomegalovirus antigen kit 30797 15 04 02 01 CMV Antigen
Cytomegalovirus nucleic acid kit 30798 15 04 02 40 CMV - NA Reagents
Cytomegalovirus total antibody kit 30799 15 04 02 04 CMV Antibodies - Total
Cytomegalovirus immunoglobulin G kit 30800 15 04 02 05 CMV IgG
Cytomegalovirus immunoglobulin M kit 30801 15 04 02 06 CMV IgM
Herpes simplex virus kit 30802 15 04 03 01 HSV Antigen
Herpes simplex virus nucleic acid kit 30803 15 04 03 40 HSV - NA Reagents
Herpes simplex virus total antibody kit 30804 15 04 03 04 HSV Antibodies - Total
Herpes simplex virus immunoglobulin G kit 30805 15 04 03 05 HSV IgG
Herpes simplex virus immunoglobulin M kit 30806 15 04 03 06 HSV IgM
Epstein-Barr virus nucleic acid kit 30808 15 04 04 40 EBV - NA Reagents
Epstein-Barr virus antibody kit 30809 15 04 04 04 EBV Antibodies
Mononucleosis 30810 15 04 04 11 Mononucleosis Inf. Imm.=> 15 70 90 03
Enterovirus kit 30811 15 04 80 02 Enterovirus
Human papillomavirus kit 30812 15 04 80 03 Human Papilloma Virus
Influenza/parainfluenza kit 30813 15 04 80 04 Influenza & Para Influenza
Respiratory syncytial virus kit 30814 15 04 80 05 Respiratory Syncytial Virus (RSV)
Rotavirus kit 30815 15 04 80 06 Rotavirus
Toxoplasma total antibody kit 30816 15 05 01 04 Toxoplasma Antibody (Total)
Toxoplasma immunoglobulin G kit 30817 15 05 01 05 Toxoplasma Antibody IgG
Toxoplasma immunoglobulin M kit 30818 15 05 01 06 Toxoplasma Antibody IgM
Entamoeba kit 30819 15 05 10 01 Entamoeba histolytica

Page 32 of 108
Chagas 30820 15 05 10 02 Chagas

Distoma kit 30821 15 05 10 03 Distomatosis
Echinococcus kit 30822 15 05 10 04 Echinococcus
Leishmania kit 30823 15 05 10 05 Leishmania
Schistosoma kit 30824 15 05 10 06 Schistosoma
H. Pylori rapid test 30825 15 70 01 02 H. Pylori - Rapid Test
Strep A rapid test 30826 15 70 01 03 Strep A - Rapid Test
Strep B rapid test 30827 15 70 01 04 Strep B - Rapid Test
Treponema rapid test kit 30828 15 70 01 05 Syphilis - Rapid Test
Hepatitis virus rapid test kit 30829 15 70 02 Hepatitis Viruses Rapid Tests
HBsAg rapid test 30830 15 70 02 01 HBsAg - Rapid Test
HCV antibody rapid test 30831 15 70 02 02 HCV Antibody - Rapid Test
Human immunodeficiency virus rapid test kit 30832 15 70 03 Retroviruses Rapid Test
HIV 1/2 rapid test 30833 15 70 03 02 HIV 1 / 2 - Rapid Test
Cytomegalovirus rapid test kit 30834 15 70 90 01 CMV - Rapid Test
Clinical chemistry instrument 30835 21 01 10 01 CH Hardware + dedicated accessories + software
Chemistry analyser 30836 21 01 10 01 CH Hardware + dedicated accessories + software
Manual photometer/spectrophotometer 30837 21 01 10 01 CH Hardware + dedicated accessories + software
Dedicated glycated haemoglobin/HbA1system 30838 21 07 10 09 Other RT_CI Hardware + dedicated accessories + software
Semi-automated CC analyser 30839 21 01 10 01 CH Hardware + dedicated accessories + software
Small automated CC analyser 30840 21 01 10 01 CH Hardware + dedicated accessories + software
Medium automated CC analyser 30841 21 01 10 01 CH Hardware + dedicated accessories + software
Large automated CC analyser 30842 21 01 10 01 CH Hardware + dedicated accessories + software
Extra large automated CC analyser 30843 21 01 10 01 CH Hardware + dedicated accessories + software
Electrolyte, flame photometer 30844 21 04 10 01 GE Hardware + dedicated accessories + software
Blood gas analyser 30845 21 04 10 01 GE Hardware + dedicated accessories + software
Blood gas, p02/pC02, pH 30846 21 04 10 01 GE Hardware + dedicated accessories + software
Analyser, blood gas, general-purpose 30847 21 04 10 01 GE Hardware + dedicated accessories + software
Blood gas/CO-oximeter 30848 21 04 10 01 GE Hardware + dedicated accessories + software
Blood gas, electrolyte, CO-oximeter 30849 21 04 10 01 GE Hardware + dedicated accessories + software
Laboratory equipment, electrophoresis 30851 21 05 10 01 EP Hardware + dedicated accessories + software
Urine analyser 30852 21 01 10 01 CH Hardware + dedicated accessories + software
Manual urine analyser 30853 21 01 10 01 CH Hardware + dedicated accessories + software
Glucose meter, self-testing 30854 21 07 10 01 Diabetes Management Hardware + dedicated accessories + software
Analyser, cholesterol 30855 21 01 10 01 CH Hardware + dedicated accessories + software
Immunochemistry instrument 30856 21 02 10 01 IC Hardware + dedicated accessories + software
Analyser, protein 30857 21 02 10 01 IC Hardware + dedicated accessories + software
Protein analyser 30858 21 02 10 01 IC Hardware + dedicated accessories + software
Large protein analyser 30859 21 02 10 01 IC Hardware + dedicated accessories + software
Analyser, immunoassay, <specify> 30860 21 02 10 01 IC Hardware + dedicated accessories + software

Page 33 of 108
2/3 part differential blood cell counter 30861 23 01 10 01 CC Hardware + dedicated accessories + software
5 part differential low/medium end blood cell counter 30862 23 01 10 01 CC Hardware + dedicated accessories + software
Analyser, haematology, reticulocyte 30863 23 01 10 01 CC Hardware + dedicated accessories + software
Flow cytometer without cell sorter 30864 23 04 10 01 FC Hardware + dedicated accessories + software
Flow cytometer with cell sorter 30865 23 04 10 01 FC Hardware + dedicated accessories + software
Fully-automated coagulation system 30866 23 02 10 01 HS Hardware + dedicated accessories + software
Sedimentation rate instrument, manual 30867 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Blood culture system 30868 24 02 10 01 BC & MB Hardware + dedicated accessories + software
Clinical centrifuge 30869 28 01 10 01 SP Hardware + accessories + software
Sample processor, immunoassay 30870 28 01 10 01 SP Hardware + accessories + software
Bacteria culture media/equipment 30891 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Analyser, gas, nitrogen, partial pressure 31240 00 00 00 00 Not for IVD use
Fletcher factor 31337 13 02 02 19 Prekallikrein / Kallikrein (Fletcher factor)
Zimmerman/Norymberski, 17-ketogenic steroid 31345 12 06 05 04 17-Ketogenic Steroids
Nitrous/nitrosonaphthol acid kit, 5-hydroxyindole 31346 12 03 90 05 5 HIAA
Porter silber hydrazone, 17-hydroxycorticosteroid 31347 12 06 05 03 17-Hydroxy-Ketosterone
L-leucyl B-naphthylamide, leucine aminopeptidase 31348 11 01 01 22 Leucine Aminopeptidase
Radioassay, vitamin B12 31349 12 07 02 04 Vitamin B12
Chromatographic separation/Zimmerman, 17-ketosteroid 31350 12 06 05 04 17-Ketogenic Steroids
Acid, vanilmandelic, diazo, p-nitroaniline/vanillin 31351 12 09 02 17 Vanillylmandelic Acid
Acid, uric, phosphotungstate reduction 31352 11 02 01 32 Uric Acid
Acid, vanilmandelic, electrophoretic separation 31353 12 09 02 17 Vanillylmandelic Acid
Berthelot indophenol, urea nitrogen 31354 11 02 01 04 Urea/Blood Urea Nitrogen
Urobilinogen kit 31355 11 70 02 01 Urine Single Test Strips (incl. tablets)
Urease, photometric, urea nitrogen 31356 11 02 01 04 Urea/Blood Urea Nitrogen
Radioimmunoassay, total triodothyronine 31357 12 04 01 05 Triiodothyronine
Free tyrosine kit 31358 12 06 90 90 Other Individual and Specified Hormones
Electrode, ion specific, urea nitrogen 31359 11 04 03 05 Urea - Electrodes
Diacetyl-monoxime, urea nitrogen 31360 11 02 01 04 Urea/Blood Urea Nitrogen
Radioimmunoassay, total thyroxine 31361 12 04 01 07 Thyroxine
Radioimmunoassay, testosterone 31362 12 05 01 10 Testosterone (with Dehydro and Free Testosterone)
Radioimmunoassay, free thyroxine 31363 12 04 01 02 Free Thyroxine
Radioimmunoassay, thyroxine-binding globulin 31364 12 04 01 09 Thyroid binding globulin
Analyser, electrophoresis, protein fractionation 31365 21 05 10 01 EP Hardware + dedicated accessories + software
Uranyl acetate/zinc acetate, sodium 31366 11 03 01 10 Sodium
Tetraphenyl borate, colorimetry, potassium 31367 11 03 01 09 Potassium
Electrode, ion specific, potassium 31368 11 03 01 09 Potassium
Urinary pH dye-indicator kit 31369 11 70 02 01 Urine Single Test Strips (incl. tablets)
Molybdenum blue method, phospholipids 31370 11 02 01 24 Phospholipids
2,4-dinitrophenylhydrazine, lactate dehydrogenase 31371 11 01 01 19 Lactate Dehydrogenase L ( LDH - L --> P )

Page 34 of 108
Phenylketone kit 31372 11 02 01 36 Phenylketonuria

Radioimmunoassay, parathyroid hormone 31373 12 06 03 14 Parathyroid Hormone (C-/N-terminal, M-regional)
Electrode, ion specific, magnesium 31374 11 04 01 05 Magnesium - Electrodes
Chromatographic derivative, total lipids 31375 11 02 01 28 Total Lipids
Sulfophosphovanillin, colorimetry, total lipids 31376 11 02 01 28 Total Lipids
Electrophoretic, lactate dehydrogenase isoenzymes 31377 11 01 01 21 Lactate Dehydrogenase Isoenzymes
Tetrazolium INT dye-diaphorase, lactate dehydrogenase 31378 11 01 01 19 Lactate Dehydrogenase L ( LDH - L --> P )
NAD reduction/NADH oxidation, lactate dehydrogenase 31379 11 01 01 19 Lactate Dehydrogenase L ( LDH - L --> P )
Radioimmunoassay, human growth hormone 31380 12 06 04 02 Human Growth Hormone
Titrimetric, magnesium 31381 11 03 01 07 Magnesium
Radioimmunoassay, immunoreactive insulin 31382 12 06 01 03 Insulin
Hexokinase, glucose 31383 11 02 01 13 Glucose
Radioimmunoassay, prolactin (lactogen) 31384 12 05 01 08 Prolactin
Copper reduction, glucose 31385 11 02 01 13 Glucose
Glucose oxidase, glucose 31386 11 02 01 13 Glucose
Ferricyanide, glucose 31387 11 02 01 13 Glucose
Orthotoluidine, glucose 31388 11 02 01 13 Glucose
Globulin kit 31389 11 02 01 30 Total Protein
Radioimmunoassay, estriol 31390 12 05 02 02 Estriol
Electrode, ion based, enzymatic, creatinine 31391 11 04 03 01 Creatinine - Electrodes
Acid, folic, radioimmunoassay 31392 12 07 01 03 Folate
Lieberman-Burchard/Abell-Kendall, colorimetric, cholesterol 31393 11 02 01 05 Cholesterol
Radioimmunoassay, cortisol 31394 12 06 02 04 Cortisol
Cyclic glutamate monophosphate kit 31395 12 06 90 90 Other Individual and Specified Hormones
Alkaline picrate, colorimetry, creatinine 31396 11 02 01 07 Creatinine
Radioimmunoassay, corticosterone 31397 12 05 01 15 Corticosteron (R/M)
Acid, ferric ion-sulfuric, cholesterol 31398 11 02 01 05 Cholesterol
Radioimmunoassay, corticoids 31399 12 05 01 15 Corticosteron (R/M)
Acid, phosphoric-thungstic (spectrophotometric), chloride 31400 11 03 01 04 Chloride
Mercuric thiocyanate, colorimetry, chloride 31401 11 03 01 04 Chloride
Immunochemical, ceruloplasmin 31402 12 01 03 02 Ceruloplasmin
Radioimmunoassay, cyclic AMP 31403 12 06 03 07 Cyclic Adenosin Monophosphate
Radioimmunoassay, estradiol 31404 12 05 01 03 Estradiol
Chromatographic/fluorometric method, catecholamines 31405 12 09 02 04 Catecholamines
Titrimetric phenol red, carbon-dioxide 31406 11 03 01 02 Bicarbonate
Bicarbonate/carbon dioxide kit, coulometric method 31407 11 03 01 02 Bicarbonate
Electrophoretic method, catecholamines 31408 12 09 02 04 Catecholamines
Methylthymol blue, calcium 31409 11 03 01 03 Calcium
Angiotensin I/renin kit 31410 12 06 02 02 Angiotensin I / II
Cresolphthalein complexone, calcium 31411 11 03 01 03 Calcium

Page 35 of 108
Vanillin pyruvate, AST/SGOT 31412 11 01 01 10 Aspartate Amino-Transferase

Diazo colorimetry, bilirubin 31413 11 02 01 03 Bilirubin
Saccharogenic, amylase 31414 11 01 01 07 Amylase - Total
Radial diffusion, amylase 31415 11 01 01 07 Amylase - Total
Cresol red colorimetry, carbon-dioxide 31416 11 03 01 02 Bicarbonate
Diazo, AST/SGOT 31417 11 01 01 10 Aspartate Amino-Transferase
Hydrazone colorimetry, AST/SGOT 31418 11 01 01 10 Aspartate Amino-Transferase
NADH oxidation/NAD reduction, AST/SGOT 31419 11 01 01 10 Aspartate Amino-Transferase
Starch-dye bound polymer, amylase 31420 11 01 01 07 Amylase - Total
Androsterone kit 31421 12 05 01 11 Androsterone
Radioimmunoassay, androstenedione 31422 12 05 01 01 Androstenedione
Amyloclastic, amylase 31423 11 01 01 07 Amylase - Total
Nitrosalicylate reduction, amylase 31424 11 01 01 07 Amylase - Total
Tetrabromophenolphthalein, albumin 31425 11 02 01 01 Albumin (CC) IC =>12.01.03.01
Tetrabromo-m-cresolsulfonphthalein, albumin 31426 11 02 01 01 Albumin (CC) IC =>12.01.03.01
Diazo, ALT/SGPT 31427 11 01 01 03 Alanine Amino-Transferase
Aldosterone kit 31428 12 06 02 01 Aldosterone
Acid phosphatase, nitrophenylphosphate 31429 11 01 01 02 Acid Phosphatase (CC) IC => 12.03.01.37
Radial immunodiffusion, albumin 31430 12 01 03 01 Albumin (IC) incl. uAlbumin CC =>11.02.01.01
Acid phosphatase, thymol blue monophosphate 31431 11 01 01 02 Acid Phosphatase (CC) IC => 12.03.01.37
Hydrazone colorimetry, aldolase 31432 11 01 01 04 Aldolase
Bromcresol purple dye-binding, albumin 31433 11 02 01 01 Albumin (CC) IC =>12.01.03.01
Azo dye, calcium 31434 11 03 01 03 Calcium
Acid, hydroxyazobenzene-benzoic, albumin 31435 11 02 01 01 Albumin (CC) IC =>12.01.03.01
NADH oxidation/NAD reduction, ALT/SGPT 31436 11 01 01 03 Alanine Amino-Transferase
Acid phosphatase, naphthyl phosphate 31437 11 01 01 02 Acid Phosphatase (CC) IC => 12.03.01.37
Hydrazone colorimetry, ALT/SGPT 31438 11 01 01 03 Alanine Amino-Transferase
Acid phosphatase, beta glycerophosphate 31439 11 01 01 02 Acid Phosphatase (CC) IC => 12.03.01.37
IgD, antigen, antiserum, control 31440 12 01 01 03 Immunoglobulin D
IgA, rhodamine, antigen, antiserum, control 31441 12 01 01 01 Immunoglobulin A
IgA, peroxidase, antigen, antiserum, control 31442 12 01 01 01 Immunoglobulin A
IgA, ferritin, antigen, antiserum, control 31443 12 01 01 01 Immunoglobulin A
IgA, FITC, antigen, antiserum, control 31444 12 01 01 01 Immunoglobulin A
Inter-alpha-trypsin inhibitor kit 31445 12 01 90 02 a1-Antitrypsin ( Protease inhibitor )
IgA, antigen, antiserum, control 31446 12 01 01 01 Immunoglobulin A
Bence-Jones protein control 31447 12 50 01 06 Specific Protein Controls
Retinol-binding protein, antigen, antiserum, control 31448 12 50 01 06 Specific Protein Controls
Complement component C3/C3c control 31449 12 50 01 06 Specific Protein Controls
Complement component C1s control 31450 12 50 01 06 Specific Protein Controls
Haptoglobin, rhodamine, antigen, antiserum, control 31451 12 01 03 03 Haptoglobin

Page 36 of 108
IgG, peroxidase, antigen, antiserum, control 31452 12 01 01 05 Immunoglobulin G

Haptoglobin, FITC, antigen, antiserum, control 31453 12 01 03 03 Haptoglobin
Complement C3b activator, antigen, antiserum, control 31454 12 01 02 03 Complement Component C3/C3c
Haptoglobin, antigen, antiserum, control 31455 12 01 03 03 Haptoglobin
Complement component C9 control 31456 12 50 01 06 Specific Protein Controls
Gamma globulin, FITC, antigen, antiserum, control 31457 12 01 01 05 Immunoglobulin G
Gamma globulin, antigen, antiserum, control 31459 12 01 01 05 Immunoglobulin G
Complement component C1r control 31460 12 50 01 06 Specific Protein Controls
Complement component C1q control 31461 12 50 01 06 Specific Protein Controls
Fraction IV-5, antigen, antiserum, control 31462 12 01 01 90 Other Immunoglobulins
Fibrinopeptide A, antigen, antiserum, control 31463 13 02 03 04 Fibrinopeptide A
Alpha2-AP-glycoprotein control 31464 12 50 01 06 Specific Protein Controls
Complement component C1 inactivator control 31466 12 50 01 06 Specific Protein Controls
Alpha2-2N-glycoprotein control 31467 12 50 01 06 Specific Protein Controls
Anti-smooth muscle antibody control 31468 12 50 01 14 Rheumatoid/Autoimmune Controls
Ferritin, antigen, antiserum, control 31469 12 07 01 02 Ferritin
FC, rhodamine, antigen, antiserum, control 31470 12 01 01 90 Other Immunoglobulins
Antiparietal cell antibody control 31472 12 50 01 14 Rheumatoid/Autoimmune Controls
FC, FITC, antigen, antiserum, control 31473 12 01 01 90 Other Immunoglobulins
FC, antigen, antiserum, control 31474 12 01 01 90 Other Immunoglobulins
Coagulation factor XIIIa/XIIIs control 31475 13 02 50 90 Other Haemostasis Controls
Fab, rhodamine, antigen, antiserum, control 31476 12 01 01 90 Other Immunoglobulins
Fab, FITC, antigen, antiserum, control 31477 12 01 01 90 Other Immunoglobulins
Fab, antigen, antiserum, control 31478 12 01 01 90 Other Immunoglobulins
Albumin, antigen, antiserum, control 31479 12 01 03 01 Albumin (IC) incl. uAlbumin CC =>11.02.01.01
System, test, C-reactive protein, rhodamine 31480 12 11 01 09 C-Reactive Protein IC=> 12 70 11 01
Beta-globulin control 31481 12 50 01 06 Specific Protein Controls
System, test, C-reactive protein 31482 12 11 01 09 C-Reactive Protein IC=> 12 70 11 01
Alpha-globulin control 31483 12 50 01 06 Specific Protein Controls
Ceruloplasmin, rhodamine, antigen, antiserum, control 31484 12 01 03 02 Ceruloplasmin
Ceruloplasmin, FITC, antigen, antiserum, control 31485 12 01 03 02 Ceruloplasmin
Ceruloplasmin, antigen, antiserum, control 31486 12 01 03 02 Ceruloplasmin
Thyroglobulin, antigen, antiserum, control 31487 12 04 01 08 Thyroglobulin
Transferrin, rhodamine, antigen, antiserum, control 31488 12 01 03 08 Transferrin
Carbonic anhydrase C, antigen, antiserum, control 31489 12 01 90 90 Other Other Plasma Proteins
Prothrombin, antigen, antiserum, control 31490 13 02 01 01 Prothrombin time ( Quick Test )
Transferrin, antigen, antiserum, control 31491 12 01 03 08 Transferrin

Page 37 of 108
Carbonic anhydrase control 31492 12 50 01 06 Specific Protein Controls

Transferrin, FITC, antigen, antiserum, control 31493 12 01 03 08 Transferrin
Thyroglobulin, FITC, antigen, antiserum, control 31494 12 04 01 08 Thyroglobulin
Beta2-glycoprotein III control 31495 12 50 01 14 Rheumatoid/Autoimmune Controls
Thyroglobulin, rhodamine, antigen, antiserum, control 31496 12 04 01 08 Thyroglobulin
Beta2-glycoprotein I control 31497 12 50 01 14 Rheumatoid/Autoimmune Controls
Myoglobin, rhodamine, antigen, antiserum, control 31498 12 13 01 05 Myoglobin
Antigen, antiserum, control, antithrombin III 31499 13 02 06 02 Antithrombin III
Myoglobin, antigen, antiserum, control 31500 12 13 01 05 Myoglobin
Prealbumin, FITC, antigen, antiserum, control 31501 12 01 03 06 Pre-albumin / Transthyretin
Albumin, FITC, antigen, antiserum, control 31502 12 01 03 01 Albumin (IC) incl. uAlbumin CC =>11.02.01.01
Myoglobin, FITC, antigen, antiserum, control 31503 12 13 01 05 Myoglobin
Inter-alpha-trypsin inhibitor control 31504 12 50 01 06 Specific Protein Controls
Alpha2-HS-glycoprotein control 31505 12 50 01 06 Specific Protein Controls
Lactoferrin, antigen, antiserum, control 31506 12 50 01 06 Specific Protein Controls
Lambda, antigen, antiserum, control 31507 12 01 01 20 Kappa and Lambda chain
Alpha-1-antitrypsin, FITC, antigen, antiserum, control 31508 12 01 90 02 a1-Antitrypsin ( Protease inhibitor )
Alpha2-glycoprotein control 31509 12 50 01 06 Specific Protein Controls
Kappa, rhodamine, antigen, antiserum, control 31510 12 01 01 20 Kappa and Lambda chain
Lipoprotein X, antigen, antiserum, control 31511 12 01 04 90 Other Lipoproteins
Alpha-1-antitrypsin, antigen, antiserum, control 31512 12 01 90 02 a1-Antitrypsin ( Protease inhibitor )
Alpha1-T-glycoprotein control 31513 12 50 01 06 Specific Protein Controls
Kappa, FITC, antigen, antiserum, control 31514 12 01 01 20 Kappa and Lambda chain
Lambda, peroxidase, antigen, antiserum, control 31515 12 01 01 20 Kappa and Lambda chain
Alpha1-lipoprotein control 31516 12 50 01 06 Specific Protein Controls
Lambda, FITC, antigen, antiserum, control 31517 12 01 01 20 Kappa and Lambda chain
Lactic dehydrogenase, antigen, antiserum, control 31518 11 01 01 19 Lactate Dehydrogenase L ( LDH - L --> P )
IgG, antigen, antiserum, control 31519 12 01 01 05 Immunoglobulin G
Alpha1-B-glycoprotein control 31520 12 50 01 06 Specific Protein Controls
IgM, peroxidase, antigen, antiserum, control 31521 12 01 01 07 Immunoglobulin M
IgM, rhodamine, antigen, antiserum, control 31522 12 01 01 07 Immunoglobulin M
Lipoprotein control 31523 12 50 01 06 Specific Protein Controls
Kappa, peroxidase, antigen, antiserum, control 31524 12 01 01 20 Kappa and Lambda chain
Alpha1-antichymotrypsin control 31525 12 50 01 06 Specific Protein Controls
Lambda, rhodamine, antigen, antiserum, control 31526 12 01 01 20 Kappa and Lambda chain
Kappa, antigen, antiserum, control 31527 12 01 01 20 Kappa and Lambda chain
Spinal fluid control 31528 11 50 90 03 CSF controls
Albumin, rhodamine, antigen, antiserum, control 31529 12 01 03 01 Albumin (IC) incl. uAlbumin CC =>11.02.01.01
IgM, ferritin, antigen, antiserum, control 31530 12 01 01 07 Immunoglobulin M
IgE, ferritin, antigen, antiserum, control 31531 12 02 01 02 Immunoglobulin E - Total

Page 38 of 108
IgG, rhodamine, antigen, antiserum, control 31532 12 01 01 05 Immunoglobulin G

Sperm, antigen, antiserum, control 31533 12 05 01 90 Other Fertility Function Hormones
IgM, FITC, antigen, antiserum, control 31534 12 01 01 07 Immunoglobulin M
IgM, antigen, antiserum, control 31535 12 01 01 07 Immunoglobulin M
Cohn fraction II, antigen, antiserum, control 31536 12 01 01 05 Immunoglobulin G
Seminal fluid control 31537 12 50 01 06 Specific Protein Controls
IgE, antigen, antiserum, control 31538 12 02 01 02 Immunoglobulin E - Total
IgG, ferritin, antigen, antiserum, control 31539 12 01 01 05 Immunoglobulin G
IgD, rhodamine, antigen, antiserum, control 31540 12 01 01 03 Immunoglobulin D
IgD, FITC, antigen, antiserum, control 31541 12 01 01 03 Immunoglobulin D
IgD, peroxidase, antigen, antiserum, control 31542 12 01 01 03 Immunoglobulin D
Breast milk control 31543 12 50 01 06 Specific Protein Controls
Colostrum control 31544 12 50 01 04 Hormone Controls
IgG, FITC, antigen, antiserum, control 31545 12 01 01 05 Immunoglobulin G
IgE, rhodamine, antigen, antiserum, control 31546 12 02 01 02 Immunoglobulin E - Total
Breast milk, antigen, antiserum, control 31547 12 01 90 90 Other Other Plasma Proteins
Breast milk, FITC, antigen, antiserum, control 31548 12 01 90 90 Other Other Plasma Proteins
IgE, peroxidase, antigen, antiserum, control 31549 12 02 01 02 Immunoglobulin E - Total
IgE, FITC, antigen, antiserum, control 31550 12 02 01 02 Immunoglobulin E - Total
System, test, systemic lupus erythematosus 31554 12 10 01 16 Systemic Lupus Erythematosus
System, test, rheumatoid factor 31555 12 11 01 10 Rheumatoid Factors
Drug mixture control material 31556 12 50 01 02 TDM/Drug Controls
Cholinesterase test strip 31557 11 70 01 90 Other Blood Test Strips
Colorimetry, cholinesterase 31558 11 01 01 11 Cholinesterase
Thin layer chromatography, quinine 31559 12 08 01 09 Quinidine
Radioimmunoassay, primidone 31560 12 08 02 09 Primidone
Gas chromatography, salicylate 31561 12 09 02 13 Salicylate
Gas chromatography, cocaine 31562 12 09 01 06 Cocaine + Cocaine Metabolites
Enzyme immunoassay, diphenylhydantoin 31563 12 08 02 90 Other Central Nervous System TDM
Free radical assay, cocaine 31564 12 09 01 06 Cocaine + Cocaine Metabolites
Enzyme immunoassay, barbiturate 31565 12 09 01 03 Barbiturates
Thin layer chromatography, amphetamine 31566 12 09 01 01 Amphetamines Group
Thin layer chromatography, phenobarbital 31567 12 08 02 07 Phenobarbital
Gas chromatography, ethosuximide 31568 12 08 02 02 Ethosuximide
Delayed analysis, alcohol 31569 12 09 02 07 Ethanol (Alcohol)
Metamphetamine kit 31570 12 09 01 02 Amphetamine/Methamphetamine Specific (+Ecstasy)
Enzyme immunoassay, primidone 31571 12 08 02 09 Primidone
Thin layer chromatography, salicylate 31572 12 09 02 13 Salicylate
Gas chromatography, opiates 31573 12 09 01 13 Opiates
Enzyme immunoassay, opiates 31574 12 09 01 13 Opiates

Page 39 of 108
Gas chromatography, phenobarbital 31575 12 08 02 07 Phenobarbital

Antiserum, gentamicin 31576 12 08 03 04 Gentamicin
Digitoxin control serum, RIA 31577 12 50 01 02 TDM/Drug Controls
Free radical assay, amphetamine 31578 12 09 01 01 Amphetamines Group
Test reagent, zinc 31579 11 02 01 33 Zinc
Mercury dithiazone, colorimetry, barbiturate 31580 12 09 01 03 Barbiturates
Radioimmunoassay, amphetamine 31581 12 09 01 01 Amphetamines Group
Phenothiazine kit 31582 12 09 01 90 Other drugs of abuse
Enzyme immunoassay, methadone 31583 12 09 01 10 Methadone
Chloral hydrate kit 31584 12 09 01 90 Other drugs of abuse
Radioimmunoassay, ethosuximide 31585 12 08 02 02 Ethosuximide
Device, breath trapping, alcohol 31586 00 00 00 00 Not for IVD use
Antiserum, digoxim 31587 12 08 01 01 Digoxin
Calibrator, drug mixture 31588 12 50 01 01 TDM/Drug Standards / Calibrators
Alcohol control material 31589 12 50 01 02 TDM/Drug Controls
Reagent, test, tetrahydrocannabinol 31590 12 09 01 05 Cannabinoids
Gas chromatography, diphenylhydantoin 31591 12 08 02 90 Other Central Nervous System TDM
Colorimetry, salicylate 31592 11 02 01 90 Other Substrates
Radioimmunoassay, barbiturate 31593 12 09 01 03 Barbiturates
Radioimmunoassay, phenobarbital 31594 12 08 02 07 Phenobarbital
Antiserum, digitoxin 31595 12 08 01 02 Digitoxin
Thin layer chromatography, methadone 31596 12 09 01 10 Methadone
Free radical assay, opiates 31597 12 09 01 13 Opiates
Sulphanimide derivative kit 31598 12 08 03 90 Other Antibiotics TDM
Thin layer chromatography, barbiturate 31599 12 09 01 03 Barbiturates
Enzyme immunoassay, amphetamine 31600 12 09 01 01 Amphetamines Group
Thin layer chromatography, codeine 31601 12 09 01 07 Codeine
Bromide kit 31602 11 03 01 90 Other Electrolytes
Enzyme immunoassay, ethosuximide 31603 12 08 02 02 Ethosuximide
Gas chromatography, alcohol 31604 12 09 02 07 Ethanol (Alcohol)
Acetylcholine choride, specific reagent, pseudo cholinesterase 31605 11 01 01 11 Cholinesterase
Calibrator, drug specific 31606 12 50 01 01 TDM/Drug Standards / Calibrators
Haemagglutination, cocaine 31607 12 09 01 06 Cocaine + Cocaine Metabolites
Radioimmunoassay, diphenylhydantoin 31608 12 08 02 90 Other Central Nervous System TDM
Enzyme immunoassay, phenobarbital 31609 12 08 02 07 Phenobarbital
Gas chromatography, methadone 31610 12 09 01 10 Methadone
Gas liquid chromatography, barbiturate 31611 12 09 01 03 Barbiturates
Lead, protoporphyrin, fluorometric 31612 12 09 02 90 Other Toxicology
Thin layer chromatography, cocaine 31613 12 09 01 06 Cocaine + Cocaine Metabolites
Digoxin control serum, RIA 31614 12 50 01 02 TDM/Drug Controls

Page 40 of 108
Gas chromatography, primidone 31615 12 08 02 09 Primidone

Enzymatic method, alcohol dehydrogenase, ultraviolet 31616 11 01 01 90 Other Enzymes
Liquid chromatography, salicylate 31617 12 09 02 13 Salicylate
Gas chromatography, morphine 31618 12 09 01 12 Morphines
Salicylate rapid test 31619 12 70 09 90 Other Drugs of Abuse/Toxicology Rapid Tests
Radioimmunoassay, digitoxin (125-I), rabbit antibody, solid phase sep. 31620 12 08 01 02 Digitoxin
Atomic absorption spectroscopy kit, antimony 31621 11 03 01 90 Other Electrolytes
Liquid chromatography, ethosuximide 31622 12 08 02 02 Ethosuximide
Free radical, benzoylecgnonine 31623 12 09 01 06 Cocaine + Cocaine Metabolites
Liquid chromatography, amphetamine 31624 12 09 01 01 Amphetamines Group
Thin layer chromatography, morphine 31625 12 09 01 12 Morphines
Radioimmunoassay, digoxin (125-I), rabbit antibody, second antibody 31626 12 08 01 01 Digoxin
Ethanol calibrator 31627 12 50 01 02 TDM/Drug Controls
Thin layer chromatography, ethosuximide 31628 12 08 02 02 Ethosuximide
Radioimmunoassay, digoxin (3-H), rabbit antibody, coated tube sep. 31629 12 08 01 01 Digoxin
Radioimmunoassay, digoxin (125-I), rabbit antibody, double label 31630 12 08 01 01 Digoxin
Liquid chromatography, methadone 31631 12 09 01 10 Methadone
Radioimmunoassay, digitoxin (3-H), rabbit antibody, charcoal sep. 31632 12 08 01 02 Digitoxin
Lead, protoporphyrin zinc method, fluorometric 31633 12 09 02 90 Other Toxicology
Atomic absorption spectroscopy kit, arsenic 31634 11 03 01 90 Other Electrolytes
Gas chromatography, amphetamine 31635 12 09 01 01 Amphetamines Group
Atomic absorption spectroscopy kit, lead 31636 11 03 01 90 Other Electrolytes
Radioimmunoassay, digoxin (125-I), rabbit antibody, polyethylene 31637 12 08 01 01 Digoxin
Electrometry, cholinesterase 31638 11 01 01 11 Cholinesterase
Potassium dichromate, alcohol 31639 12 09 02 07 Ethanol (Alcohol)
Free radical assay, morphine 31640 12 09 01 12 Morphines
Free radical assay, LSD 31641 12 09 01 09 Lysergic acid diethylamide
Thin layer chromatography, benzoylecgnonine 31642 12 09 01 06 Cocaine + Cocaine Metabolites
Liquid chromatography, phenobarbital 31643 12 08 02 07 Phenobarbital
Analyser, mass spectrometry 31644 21 04 10 01 GE Hardware + dedicated accessories + software
Thin layer chromatography, primidone 31645 12 08 02 09 Primidone
Analyser, lead 31646 21 01 10 01 CH Hardware + dedicated accessories + software
Liquid chromatography, diphenylhydantoin 31647 12 08 02 90 Other Central Nervous System TDM
Radioimmunoassay, digoxin (125-I), rabbit antibody, charcoal sep. 31648 12 08 01 01 Digoxin
Thin layer chromatography, diphenylhydantoin 31649 12 08 02 90 Other Central Nervous System TDM
Mercury kit 31650 12 09 02 90 Other Toxicology
Liquid chromatography, morphine 31651 12 09 01 12 Morphines
Thin layer chromatography, propoxyphene 31652 12 09 01 15 Propoxyphene
Radioimmunoassay, digoxin (125-I), rabbit antibody, coated tube sep. 31653 12 08 01 01 Digoxin
Free radical assay, methadone 31654 12 09 01 10 Methadone

Page 41 of 108
Liquid chromatography, primidone 31655 12 08 02 09 Primidone

Densitometer 31737 21 05 10 01 EP Hardware + dedicated accessories + software
Activated partial thromboplastin 32392 13 02 01 02 Activated Partial Thromboplastin Time
Fibrinogen control 32393 13 02 50 90 Other Haemostasis Controls
Control, plasma, abnormal 32394 13 02 50 02 Control Plasmas
Acid hematin 32395 13 07 01 02 Cytochemical staining reagents
Guaiac reagent 32396 11 70 03 01 Faecal Occult Blood (CC) IC =>12.03.90.04
White blood cell control 32397 13 01 20 90 Other Haematology Controls
Control, hemoglobin 32398 13 01 20 04 Haemoglobin Control
Plasma, coagulation control 32399 13 02 50 02 Control Plasmas
Test, prothrombin consumption 32400 13 02 01 01 Prothrombin time ( Quick Test )
Assay, erythropoietin 32401 12 07 01 01 Erythropoietin
Test, time, partial thromboplastin 32402 13 02 01 02 Activated Partial Thromboplastin Time
Tube, sedimentation rate 32403 13 01 09 11 Erythrocyte Sedimentation Rate Test
Test, leukocyte alkaline phosphatase 32404 11 01 01 05 Alkaline Phosphatase - Total
Fibrin split product 32405 13 02 05 02 Fibrinogen Degradation Products
Centrifuge, microsedimentation 32406 28 01 10 01 SP Hardware + accessories + software
Test, sickle cell 32407 16 01 01 09 Sickle Cell Anemia
Haemocytometer 32408 23 05 10 01 HC Hardware + dedicated accessories + software
Reagent, platelet aggregation 32409 13 02 04 01 Aggregation Factors
Carboxyhaemoglobin kit 32410 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
Haematocrit kit 32411 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Solution, gugol blue 32412 13 01 03 90 Other Haematology stains
Fibrometer 32413 23 02 10 01 HS Hardware + dedicated accessories + software
Diluent, blood cell 32414 13 01 01 01 CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)
Haemoglobinometer 32415 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Glutathione, red-cell 32416 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Plasma, fibrinogen control 32417 13 02 50 02 Control Plasmas
Haemoglobin S 32418 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
Test, fibrinogen 32419 13 02 02 01 Fibrinogen Assays (Factor I)
Plasma, control, normal 32420 13 02 50 02 Control Plasmas
Test, thrombin time 32421 13 02 01 03 Thrombin Time / Reptilase / Batroxobin Time
Thrombin 32422 13 02 01 03 Thrombin Time / Reptilase / Batroxobin Time
Sulfhaemoglobin kit 32423 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
Romanowsky stain 32424 13 01 03 02 Romanowsky stains
Control, platelet 32425 13 01 20 05 Platelet Control
Red blood cell control 32426 13 01 20 03 Control Blood Multilevel
Test, time, prothrombin 32427 13 02 01 01 Prothrombin time ( Quick Test )
Device, automated sedimentation rate 32428 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Centrifuge, haematocrit 32429 23 09 10 01 Other_HHC Hardware + dedicated accessories + software

Page 42 of 108
Cyanomethemoglobin kit 32430 13 01 02 01 Haemoglobin determinations (Total Hb)

Counter, cell, automated (particle counter) 32431 23 01 10 01 CC Hardware + dedicated accessories + software
Instrument, coagulation, automated 32433 23 02 10 01 HS Hardware + dedicated accessories + software
Test, thromboplastin generation 32434 13 02 01 02 Activated Partial Thromboplastin Time
System, haemoglobin, automated 32435 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Aggregometer, platelet, thrombokinetogram 32436 23 02 10 01 HS Hardware + dedicated accessories + software
Instrument, automated platelet counting 32437 23 01 10 01 CC Hardware + dedicated accessories + software
Counter, differential cell 32438 23 01 10 01 CC Hardware + dedicated accessories + software
Platelet counting, manual 32439 13 01 01 90 Other Reagents for Haematology Analyzer
Haematocrit control 32440 13 01 20 90 Other Haematology Controls
Sporothrix schenekii kit 32442 15 06 01 90 Other Mycology Immunoassays
Antigen, latex agglutination, Coccidioides immitis 32443 15 06 01 90 Other Mycology Immunoassays
Coccidioides immitis control 32444 15 50 01 06 Mycology Controls - Inf.Imm.
Antigen, Histoplasma capsulatum, all 32445 15 06 01 90 Other Mycology Immunoassays
Histoplasma capsulatum control 32446 15 50 01 06 Mycology Controls - Inf.Imm.
Nontreponemal control 32449 15 50 01 01 Bacteriology Controls - Inf.Imm.
Nontreponemal kit 32450 15 01 90 90 Other Other Bacteriology Immunoassays
Serum, reactive/non-specific control, FTA-ABS test 32451 15 01 03 03 Syphilis Antibody Assays Total
Anti-human globulin, FTA-ABS test 32452 15 01 03 03 Syphilis Antibody Assays Total
Antigen, HA, Treponema pallidum 32453 15 01 03 01 Syphilis Antigen Detection
Test, sorbent, FTA-ABS 32454 15 01 03 03 Syphilis Antibody Assays Total
Antisera, fluorescent antibody for FTA-ABS test 32455 15 01 03 03 Syphilis Antibody Assays Total
Antigen, IHA, T. cruzi 32456 15 05 10 02 Chagas
Antigen, latex agglutination, T. cruzi 32457 15 05 10 02 Chagas
Antigen, CF, T. cruzi 32458 15 05 10 02 Chagas
Antigen, HA, echovirus 1-34 32459 15 04 80 90 Other Viral Antigen/Antibody Detection
Antiserum, CF, Epstein-Barr virus 32460 15 04 04 04 EBV Antibodies
Antigen, HA including HA control, influenza virus C 32461 15 04 80 04 Influenza & Para Influenza
Antigen, CF including CF control, influenza virus C 32462 15 04 80 04 Influenza & Para Influenza
Antiserum, fluorescent, rabies virus 32463 15 04 80 90 Other Viral Antigen/Antibody Detection
Antiserum, fluorescent, C. diphtheriae 32466 15 01 90 08 Diphteria (Corynebacterium D.)
Antigen, B. parapertussis 32467 15 01 90 07 Bordetella pertussis / parapertussis
Antigen, B. pertussis 32468 15 01 90 07 Bordetella pertussis / parapertussis
Antigen, latex agglutination, Trichinella spiralis 32469 15 05 10 90 Other Parasitology
Antigen, bentonite flocculation, Trichinella spiralis 32470 15 05 10 90 Other Parasitology
Antiserum, fluorescent, Q fever 32471 15 01 90 03 Coxiella
Antiserum, rickettsial pox 32472 15 01 90 05 Rickettsia
Antiserum, murine typhus fever 32473 15 01 90 05 Rickettsia
Antiserum, typhus fever 32474 15 01 90 05 Rickettsia
Antigen, CF, typhus fever group 32475 15 01 90 05 Rickettsia

Page 43 of 108
Antiserum, rocky mountain spotted fever 32476 15 01 90 05 Rickettsia

Antigen, CF, spotted fever group 32477 15 01 90 05 Rickettsia
Antiserum, CF, Q fever 32478 15 01 90 03 Coxiella
Antigen, CF, Q fever 32479 15 01 90 03 Coxiella
Antiserum, CF, psittacosis (Chlamydia group) 32480 15 01 01 90 Other Chlamydia Reagents
Rhinovirus kit 32481 15 04 80 90 Other Viral Antigen/Antibody Detection
Cytomegalovirus antigen control 32483 15 50 01 04 Other Virology Controls - Inf.Imm.
Antiserum, CF, cytomegalovirus 32484 15 04 02 04 CMV Antibodies - Total
Antiserum, CF, lymphocytic choriomeningitis virus 32485 15 04 80 13 LCM Virus
Antigen, CF, lymphocytic choriomeningitis virus 32486 15 04 80 13 LCM Virus
Parainfluenza virus kit 32487 15 04 80 04 Influenza & Para Influenza
Antiserum, fluorescent, mumps virus 32488 15 04 80 08 Mumps / Parotitis
Antiserum, CF, mumps virus 32489 15 04 80 08 Mumps / Parotitis
Antiserum, HAI, mumps virus 32490 15 04 80 08 Mumps / Parotitis
Antiserum, fluorescent, rubeola 32491 15 04 01 04 Rubella Virus Antibodies - Total
Antiserum, CF, rubeola 32492 15 04 01 04 Rubella Virus Antibodies - Total
Antiserum, HAI, rubeola 32493 15 04 01 04 Rubella Virus Antibodies - Total
Antigen, all groups, salmonella spp 32495 15 01 10 01 Salmonella Antigen Detection
Antiserum, fluorescent, Mycobacterium tuberculosis 32496 15 01 07 03 Mycobacterial Antibody Assays
Antiserum, fluorescent, Erysipelothrix rhusiopathiae 32497 15 01 90 90 Other Other Bacteriology Immunoassays
Antiserum, Erysipelothrix rhusiopathiae 32498 15 01 90 90 Other Other Bacteriology Immunoassays
Antigen, Erysipelothrix rhusiopathiae 32499 15 01 90 90 Other Other Bacteriology Immunoassays
Antiserum, fluorescent, Francisella tularensis 32500 15 01 90 90 Other Other Bacteriology Immunoassays
Antiserum, Francisella tularensis 32501 15 01 90 90 Other Other Bacteriology Immunoassays
Febrile antigen control 32502 15 50 01 01 Bacteriology Controls - Inf.Imm.
Vibrio cholerae kit 32504 15 01 90 90 Other Other Bacteriology Immunoassays
Antiserum, Pseudomonas pseudomallei 32505 15 01 90 13 Pseudomonas
Flavobacterium meningosepticum kit 32506 15 01 90 90 Other Other Bacteriology Immunoassays
Acinetobacter calcoaceticus kit 32507 14 02 03 01 Serotyping (E.coli, Salmonella, Shigella, etc.)
Serratia marcesans kit 32508 15 01 90 90 Other Other Bacteriology Immunoassays
Arizona kit 32509 14 02 03 01 Serotyping (E.coli, Salmonella, Shigella, etc.)
Citrobacter kit 32510 14 90 90 90 Other Other Microbiology Tests
Anti-streptokinase 32513 12 11 01 03 Anti-Streptokinase (ASK)
Antigen, all group, Streptococcus spp. 32514 15 01 11 01 Streptococcal Direct Antigen Detection
Solution, Fontanna silver 32887 13 01 03 01 Histo/Cyto stains
Giemsa stain 32888 13 01 03 01 Histo/Cyto stains
Glenner's stain 32889 13 01 03 01 Histo/Cyto stains
Gold chloride 32890 13 01 03 01 Histo/Cyto stains
Hematoxylin 32891 13 01 03 01 Histo/Cyto stains
Iron chloride-weigert 32892 13 01 03 01 Histo/Cyto stains

Page 44 of 108
Leuco-patent blue 32893 13 01 03 01 Histo/Cyto stains

Light green 32894 13 01 03 01 Histo/Cyto stains
Luxol fast blue 32895 13 01 03 01 Histo/Cyto stains
Metanil yellow 32896 13 01 03 01 Histo/Cyto stains
Methyl green 32897 13 01 03 01 Histo/Cyto stains
Mucicarmine 32898 13 01 03 01 Histo/Cyto stains
Muller's colloidal iron 32899 13 01 03 01 Histo/Cyto stains
Nile blue 32900 13 01 03 01 Histo/Cyto stains
Nuclear fast red 32901 13 01 03 01 Histo/Cyto stains
Oil red O 32902 13 01 03 01 Histo/Cyto stains
Orange G 32903 13 01 03 01 Histo/Cyto stains
Phloxine B 32904 13 01 03 01 Histo/Cyto stains
Hematoxylin, acid, phosphotungstic 32905 13 01 03 01 Histo/Cyto stains
Picro methyl blue 32906 13 01 03 01 Histo/Cyto stains
Pyronin 32907 13 01 03 01 Histo/Cyto stains
Red-violet LB 32908 13 01 03 01 Histo/Cyto stains
Resorcin fuchsin 32909 13 01 03 01 Histo/Cyto stains
Safranin 32910 13 01 03 01 Histo/Cyto stains
Sirius red 32911 13 01 03 01 Histo/Cyto stains
Sudan black B 32912 13 01 03 01 Histo/Cyto stains
Titan yellow 32913 13 01 03 01 Histo/Cyto stains
Toluidine blue 32914 13 01 03 01 Histo/Cyto stains
Van Gieson's picro-fuchsin 32915 13 01 03 01 Histo/Cyto stains
Heparin 32918 13 02 03 05 Heparin
Streptolysin O 32919 12 11 01 05 Anti-Streptolysin/Anti-Streptolysin O (qualitative)
Diastase 32920 11 01 01 07 Amylase - Total
Hyaluronidase 32921 12 11 01 02 Anti-Streptococcal Hyaluronidase
Trypsin 32922 11 01 01 30 Trypsin (CC) IC =>12.01.90.07
Hematoxylin, chrome alum 32924 14 01 08 02 Other Stains
Best's carmine 32925 14 01 08 02 Other Stains
Bath, flotation, tissue 32931 00 00 00 00 Not for IVD use
Cytocentrifuge 32933 28 01 10 01 SP Hardware + accessories + software
Solution, decalcifier, electrolytic 32934 13 02 80 90 Other Auxiliary Reagents (Haemostasis)
Formalin, neutral buffered 32938 00 00 00 00 Not for IVD use
Gelatin-formalin 32941 00 00 00 00 Not for IVD use
Solution, formalin-sodium acetate 32942 00 00 00 00 Not for IVD use
Formalin-saline 32943 00 00 00 00 Not for IVD use
Solution, formol calcium 32944 00 00 00 00 Not for IVD use
Solution, formalin ammonium bromide 32945 00 00 00 00 Not for IVD use
Solution, formalin-alcohol-acetic acid 32946 00 00 00 00 Not for IVD use

Page 45 of 108
Fibrin monomer paracoagulation 33154 13 02 03 03 Fibrin sensitivity monomer

Activated whole blood clotting time kit 33155 13 02 01 04 Activated Clotting Time
Antithrombin III quantitation 33156 13 02 06 02 Antithrombin III
Timer, general laboratory 33157 00 00 00 00 Not for IVD use
Aggregrometer, platelet 33158 23 02 10 01 HS Hardware + dedicated accessories + software
Aggregometer, platelet, photo-optical scanning 33159 23 02 10 01 HS Hardware + dedicated accessories + software
Study, platelet adhesive 33160 00 00 00 00 Not for IVD use
Fluid, diluting, manual cell 33163 13 01 01 01 CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)
Acid phosphatase, cytochemical 33164 11 01 01 02 Acid Phosphatase (CC) IC => 12.03.01.37
Alkaline phosphatase kit 33165 11 01 01 05 Alkaline Phosphatase - Total
Bothrops atrox reagent 33166 13 02 03 90 Other Special Coagulation Tests
Analyzer, oxyhemoglobin concentration, blood-phase, indwelling 33195 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Analyser, gas, neon 33196 00 00 00 00 Not for IVD use
Analyser, gas, argon 33197 00 00 00 00 Not for IVD use
Catalytic methods, amylase 33214 11 01 01 07 Amylase - Total
pH rate measurement, carbon-dioxide 33215 11 04 02 01 Carbon Dioxide - Electrodes
Enzymatic method, bilirubin 33216 11 02 01 03 Bilirubin
Atomic absorption spectroscopy kit, calcium 33217 11 03 01 03 Calcium
Fluorometric, calcium 33218 11 03 01 03 Calcium
Electrode, ion specific, calcium 33219 11 04 01 02 Calcium - Electrodes
Indirect copper assay, ceruloplasmin 33220 12 01 03 02 Ceruloplasmin
Coulometric, chloride 33221 11 03 01 04 Chloride
Fluorometric, cortisol 33222 12 06 02 04 Cortisol
Enzymatic method, creatinine 33223 11 02 01 07 Creatinine
Nephelometric method, globulin 33224 11 02 01 01 Albumin (CC) IC =>12.01.03.01
Turbidimetric method, globulin 33225 11 02 01 01 Albumin (CC) IC =>12.01.03.01
Atomic absorption spectroscopy kit, magnesium 33226 11 03 01 07 Magnesium
Photometric method, magnesium 33227 11 03 01 07 Magnesium
Flame photometry, potassium 33228 11 03 01 09 Potassium
Turbidimetric, total protein 33229 11 02 01 30 Total Protein
Refractometric, total protein 33230 11 02 01 30 Total Protein
Electrode, ion specific, sodium 33231 11 04 01 07 Sodium - Electrodes
Flame photometry, sodium 33232 11 03 01 10 Sodium
Fluorometric method, triglycerides 33233 11 02 01 31 Triglycerides
Turbidimetric method, triglyceride 33234 11 02 01 31 Triglycerides
Colorimetric method, triglyceride 33235 11 02 01 31 Triglycerides
O-phthalaldehyde, urea nitrogen 33236 11 02 01 04 Urea/Blood Urea Nitrogen
Fluorometric method, 17-hydroxycorticosteroid 33237 12 06 05 03 17-Hydroxy-Ketosterone
Radioassay, 17-hydroxycorticosteroid 33238 12 06 05 03 17-Hydroxy-Ketosterone
Electrophoretic method, lecithin/sphingomyelin ratio 33239 11 02 01 34 Lipoprotein Electrophoresis

Page 46 of 108
Microdensitometry method, lipoproteins 33240 11 02 01 34 Lipoprotein Electrophoresis

Turbidimetric method, lipoproteins 33241 11 02 01 20 Lipoprotein, Chemical determination/detection
Electrophoretic separation, lipoproteins 33242 11 02 01 34 Lipoprotein Electrophoresis
Radial immunodiffusion, lipoproteins 33243 12 01 04 21 Lipoprotein ( a )
Nephelometric method, lipoprotein 33244 11 02 01 20 Lipoprotein, Chemical determination/detection
Chromatographic separation, CPK isoenzymes 33245 11 01 01 15 Creatine Kinase Isoenzymes
Enzymatic method, galactose 33246 11 02 01 12 Galactose
Colorimetric method, galactose 33247 11 02 01 12 Galactose
Photometric method, ammonia 33248 11 03 01 01 Ammonia
Method, ion-exchange, ammonia 33249 11 03 01 01 Ammonia
Enzymatic method, ammonia 33250 11 03 01 01 Ammonia
Atomic absorption spectroscopy kit, lithium 33251 11 03 01 06 Lithium
Wet ash method, protein-bound iodine 33252 12 04 01 90 Other thyroid hormones
Iodine kit 33253 12 04 01 90 Other thyroid hormones
Enzymatic method, glucose, urinary, non-quantitative 33254 11 70 02 01 Urine Single Test Strips (incl. tablets)
Metallic reduction method, glucose, urinary non-quantitative 33255 11 70 02 01 Urine Single Test Strips (incl. tablets)
Ketone kit 33256 11 70 02 01 Urine Single Test Strips (incl. tablets)
Urine occult blood kit 33257 11 70 02 01 Urine Single Test Strips (incl. tablets)
Blood, occult, enzymatic method, in urine 33258 11 70 02 01 Urine Single Test Strips (incl. tablets)
Calibrator, primary 33259 11 50 03 02 Calibrators Single Component (CC)
Calibrator, secondary 33260 11 50 03 02 Calibrators Single Component (CC)
Calibrator, surrogate 33261 11 50 03 02 Calibrators Single Component (CC)
Calibrator, multi-analyte mixture 33262 11 50 03 01 Calibrators Multicomponent (CC)
Atomic absorption spectroscopy kit, iron 33263 11 02 01 16 Iron (CC) IC =>12.07.01.04
Clinical sample concentrator 33264 28 01 10 01 SP Hardware + accessories + software
Enzyme analyser, clinical use 33265 21 01 10 01 CH Hardware + dedicated accessories + software
Osmometer for clinical use 33266 00 00 00 00 Not for IVD use
Apparatus, electrophoresis, for clinical use 33267 21 05 10 01 EP Hardware + dedicated accessories + software
Dinitrophenyl hydrazone kit 33268 11 70 02 01 Urine Single Test Strips (incl. tablets)
Isocitric dehydrogenase kit 33269 11 01 01 90 Other Enzymes
Fluorometric measurement, porphyrin 33270 11 02 01 29 Total Porphyrine
Acid, delta-aminolevulinic, ion-exchange columns with colorimetry 33271 11 02 01 09 Delta-Aminolaevulinic acid
Bence-Jones protein kit 33272 12 01 01 20 Kappa and Lambda chain
Chromium-51 solution 33273 00 00 00 00 Not for IVD use
Radioimmunoassay, calcitonin 33274 12 06 03 02 Calcitonin
Analyser, oxyhaemoglobin 33275 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
N-acetyl-l-tyrosine ethyl ester (U.V.), chymotrypsin 33276 11 01 01 12 Chymotrypsin
N-benzoyl-l-tyrosine ethyl ester (U.V.), chymotrypsin 33277 11 01 01 12 Chymotrypsin
Oxalydihydrazide (spectroscopic), copper 33278 11 02 01 06 Copper
Diethyldithiocarbamate (colorimetric), copper 33279 11 02 01 06 Copper

Page 47 of 108
Conversion to creatinine, creatine 33280 11 02 01 07 Creatinine

Cystine kit 33281 12 06 90 90 Other Individual and Specified Hormones
Radioimmunoassay, desoxycorticosterone 33282 12 05 01 14 11-Desoxycortisol
Titrimetric, fatty acids 33283 11 02 01 22 Non Esterified Fatty Acids
Chromatographic, glutathione 33284 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Enzymatic glutathione kit 33285 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Spectrophotometric method, pregnanetriol 33286 12 05 01 07 17 OH Progesterone
Pregnanetriol kit 33287 12 05 01 07 17 OH Progesterone
Radioummunoassay, progesterone 33288 12 05 01 06 Progesterone
Acid, pyruvic, enzymatic (U.V.) 33289 11 02 01 26 Pyruvate
Radioimmunoassay, thyroid-stimulating hormone 33290 12 04 01 11 Thyroid Stimulating Hormone
Radioimmunoassay, 17-hydroxyprogesterone 33291 12 05 01 07 17 OH Progesterone
Ascorbic acid kit 33292 11 02 01 90 Other Substrates
Oestrogen kit 33293 12 05 02 04 Estrone
Radioimmunoassay, glucagon 33294 12 06 01 02 Glucagon
Radioimmunoassay, human placental lactogen 33295 12 05 02 07 Human Placental Lactogen
Histidine kit 33296 12 06 90 90 Other Individual and Specified Hormones
Microbiological, histidine 33297 12 06 90 90 Other Individual and Specified Hormones
Alpha-ketobutyric acid kit 33298 11 01 01 18 Hydroxybutyrate Dehydrogenase
Malic acid kit 33299 11 01 01 25 Malate Dehydrogenase
Nitrite kit 33300 11 70 02 01 Urine Single Test Strips (incl. tablets)
Pregnenolone kit 33301 12 05 02 90 Other Pregnancy Testing Hormones
Beta-D-fructose/NADH oxidation UV, sorbitol 33302 11 01 01 29 Sorbitol Dehydrogenase
Immunochemical, thyroglobulin autoantibody 33303 12 10 03 04 Thyroglobulin Autoantibodies
Immunochemical, transferrin 33304 12 01 03 08 Transferrin
Chromatographic, phospholipids 33305 11 02 01 24 Phospholipids
Fluorometric, uroporphyrin 33306 11 02 01 90 Other Substrates
Trifluoroacetic acid, vitamin A, hexane extraction 33307 12 07 02 90 Other Vitamin Tests
Colorimetric, xylose 33308 11 02 01 08 D-Xylose
Analyser, heparin 33321 23 02 10 01 HS Hardware + dedicated accessories + software
System, automated platelet aggregation 33322 23 02 10 01 HS Hardware + dedicated accessories + software
Haemoglobin M 33323 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
Haemoglobin F quantitation 33324 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
Haemoglobin A2 quantitation 33325 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
Antithrombin III, two stage clotting time assay 33326 13 02 06 02 Antithrombin III
Test, erythrocyte sedimentation rate 33327 13 01 09 11 Erythrocyte Sedimentation Rate Test
Analyser, haematology, haematocrit 33328 23 01 10 01 CC Hardware + dedicated accessories + software
Colorimetric method, gamma-glutamyl transpeptidase 33330 11 01 01 16 Gamma Glutamyltransferase
Kinetic method, gamma-glutamyl transpeptidase 33331 11 01 01 16 Gamma Glutamyltransferase
Centrifuges (micro, ultra, refrigerated) for clinical use 33332 28 01 10 01 SP Hardware + accessories + software

Page 48 of 108
Bathophenanthroline, iron binding capacity 33333 11 02 01 17 Iron Binding Capacity - Total (CC) IC =>12.07.01.05
Radiometric, FE59, iron binding capacity 33334 12 07 01 05 Iron Binding Capacity - Total (IC) CC =>11.02.01.17
Nitrogen kit 33335 11 02 01 04 Urea/Blood Urea Nitrogen
Uroporphyrin kit 33336 11 02 01 90 Other Substrates
P-bromoaniline, xylose 33337 11 02 01 08 D-Xylose
Mucopolysaccharide kit 33338 11 02 01 90 Other Substrates
Balance, analytical 33339 00 00 00 00 Not for IVD use
Nephelometer, for clinical use 33341 21 02 10 01 IC Hardware + dedicated accessories + software
pH meter 33342 00 00 00 00 Not for IVD use
Culture medium, amino acid assay 33345 14 90 90 90 Other Other Microbiology Tests
Culture medium, antibiotic assay 33346 14 02 05 01 MIC Systems - Manual
Culture medium, vitamin assay 33347 14 90 90 90 Other Other Microbiology Tests
Culture medium general nutrient broth 33348 14 01 02 01 Broth Media (Tubes)
Culture media, single biochemical test 33349 14 02 02 90 Other Manual Identification (Optichin, Bacitracin etc.)
Culture medium, non-selective/non-differential 33350 14 01 03 01 Agar Media for Pouring (Bottles)
Culture medium, non-selective/differential 33351 14 01 Bacteriology - Culture
Culture medium, selective/differential 33352 14 01 Bacteriology - Culture
Culture medium, selective/non-differential 33353 14 01 Bacteriology - Culture
Culture medium supplement 33354 14 01 01 04 Additives for DCM
Culture medium, transport, anaerobic 33355 24 09 30 01 Other_MCB Consumables
Culture media, antimicrobial susceptibility test, excluding Mueller 33356 14 02 05 01 MIC Systems - Manual
Kit, anaerobic identification 33357 14 02 02 05 Anaerobes - Manual
Dermatophyte kit 33358 14 03 04 02 Identification Systems for Fungi - Manual
Enterobacteriaceae kit 33359 14 02 02 01 Enterobacteriaceae - Manual
Fastidious organism kit 33360 14 02 02 90 Other Manual Identification (Optichin, Bacitracin etc.)
Glucose nonfermenter kit 33361 14 02 02 02 Non-fermenters - Manual
Kit, identification, Mycobacteria 33362 15 01 07 01 Mycobacterial Antigen Detection
Kit, identification, Pseudomonas 33363 15 01 90 13 Pseudomonas
Disc, strips and reagent, microorganism differentiation 33364 24 01 30 01 SI Consumables
Culture medium control 33365 14 01 08 90 Miscellaneous Buffers, Controls and Standards
Stain, microbiologic 33366 14 01 08 Stains, Buffers etc (Bacteriology)
Culture medium, Neisseria isolation, pathogenic 33367 14 02 02 06 Haemophilus & Neisseria - Manual
Culture medium, antimicrobial susceptibility test 33368 14 02 05 01 MIC Systems - Manual
Cryptococcus neoformans control 33372 15 50 01 06 Mycology Controls - Inf.Imm.
Antigen, Treponema pallidum for FTA-ABS test 33373 15 01 03 01 Syphilis Antigen Detection
Blood volume measuring 33375 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Adenosine triphosphate kit 33376 12 12 01 90 Other Liver Function
Antigen, CF, B. dermatitidis 33377 15 06 01 90 Other Mycology Immunoassays
Kit, screening, Staphylococcus aureus 33378 15 01 12 01 Staphylococcal Direct Antigen Detection
Trichomonas kit 33379 15 05 10 90 Other Parasitology

Page 49 of 108
Kit, screening, urine 33380 14 01 07 02 Urine Screening Manual (Strips etc.)

Kit, identification, yeast 33381 14 03 04 01 Identification Systems for Yeasts - Manual
Kit, screening, yeast 33382 14 03 04 01 Identification Systems for Yeasts - Manual
Enzyme immunoassay, propoxyphene 33387 12 09 01 15 Propoxyphene
Enzyme immunoassay, cocaine 33388 12 09 01 06 Cocaine + Cocaine Metabolites
Atomic absorption spectrophotometer, general use 33389 21 04 10 01 GE Hardware + dedicated accessories + software
System, test, beta-2-microglobulin immunological 33418 12 03 90 02 Beta2-Microglobulin
Properdin factor B control 33419 12 01 02 90 Other Complement Components
Prealbumin, antigen, antiserum, control 33420 12 01 03 06 Pre-albumin / Transthyretin
Electrophoresis instrumentation 33422 21 05 10 01 EP Hardware + dedicated accessories + software
Fluorometer 33423 21 02 10 01 IC Hardware + dedicated accessories + software
Nephelometer 33424 21 02 10 01 IC Hardware + dedicated accessories + software
Solution, decalcifier, acid containing 33486 13 02 80 90 Other Auxiliary Reagents (Haemostasis)
Chelating agent, decalcification 33487 13 02 80 90 Other Auxiliary Reagents (Haemostasis)
Fixative, osmium tetroxide 33488 13 07 01 05 Fixing reagents (Histology/Cytology)
Fixative, paraformaldehyde 33489 13 07 01 05 Fixing reagents (Histology/Cytology)
Mounting medium, oil soluble 33494 13 07 01 06 Mounting media (Histology/Cytology)
Mounting medium, water soluble 33495 13 07 01 06 Mounting media (Histology/Cytology)
Neutral red 33496 14 01 08 02 Other Stains
Assay, heparin 33497 13 02 03 05 Heparin
Blastomyces dermatitidis control 33498 15 50 01 06 Mycology Controls - Inf.Imm.
Strip, virulence, Corynebacterium diphtheriae 33499 15 01 90 08 Diphteria (Corynebacterium D.)
Adenine nucleotide kit 33524 13 01 90 90 Other Other Haematology Reagents
Nephelometric, amylase 33527 11 01 01 07 Amylase - Total
Fluorometer, for clinical use 33528 21 02 10 01 IC Hardware + dedicated accessories + software
Acid, lactic, enzymatic method 33529 11 02 01 18 Lactate
Radioassay, triiodothyronine uptake 33530 12 04 01 06 T- Uptake
Enzymatic, carbon-dioxide 33532 11 03 01 02 Bicarbonate
Fraction V, antigen, antiserum, control 33533 12 01 01 90 Other Immunoglobulins
Cell, animal/human, cultured 33543 14 04 01 01 Cells for Tissue Culture
Kit, Mycoplasma detection 33544 15 01 08 01 Mycoplasma Antigen Detection
Culture medium, Mycoplasma detection 33545 14 02 02 07 Mycoplasma - Manual
Radioimmunoassay, kanamycin 33546 12 08 03 05 Kanamycin
Indigocarmine 33548 13 01 03 01 Histo/Cyto stains
Janus green B 33549 13 01 03 01 Histo/Cyto stains
Malachite green 33550 13 01 03 01 Histo/Cyto stains
Martius yellow 33551 13 01 03 01 Histo/Cyto stains
Methyl orange 33552 13 01 03 01 Histo/Cyto stains
Methyl violet 2B 33553 13 01 03 01 Histo/Cyto stains
Methylene violet 33554 13 01 03 01 Histo/Cyto stains

Page 50 of 108
Nigrosin 33555 13 01 03 01 Histo/Cyto stains

Orange II 33556 13 01 03 01 Histo/Cyto stains
Orcein 33557 13 01 03 01 Histo/Cyto stains
Protargol S 33558 13 01 03 01 Histo/Cyto stains
Rose bengal 33559 13 01 03 01 Histo/Cyto stains
Sudan III 33560 13 01 03 01 Histo/Cyto stains
Sudan IV 33561 13 01 03 01 Histo/Cyto stains
Thionin 33562 13 01 03 01 Histo/Cyto stains
Methylene blue thiocyanate 33563 13 01 03 01 Histo/Cyto stains
Periodic acid kit 33564 13 01 03 01 Histo/Cyto stains
Radioimmunoassay, tobramycin 33566 12 08 03 09 Tobramycin
Enzyme immunoassay, non-radiolabeled, total thyroxine 33569 12 04 01 07 Thyroxine
Radioimmunoassay, cocaine metabolite 33570 12 09 01 06 Cocaine + Cocaine Metabolites
Enzymatic radiochemical assay, gentamicin 33571 12 08 03 04 Gentamicin
Amikacin serum assay 33572 12 08 03 01 Amikacin
Radioimmunoassay, amikacin 33573 12 08 03 01 Amikacin
Enzyme immunoassay, lidocaine 33574 12 08 01 05 Lidocaine
Enzyme immunoassay, theophylline 33575 12 08 04 02 Theophylline
Enzyme immunoassay, carbamazepine 33576 12 08 02 01 Carbamazepine
Phenolphthalein colorimetry, carbon-dioxide 33590 11 03 01 02 Bicarbonate
Slide stainer, automated 33617 23 05 10 01 HC Hardware + dedicated accessories + software
Stain, hematology 33637 13 01 03 90 Other Haematology stains
Glucose-6-phosphate dehydrogenase kit 33638 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Assay, glutathione reductase 33639 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Instrument, coagulation 33640 23 02 10 01 HS Hardware + dedicated accessories + software
Assay, foetal haemoglobin 33641 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
System, fibrinogen determination 33642 13 02 02 01 Fibrinogen Assays (Factor I)
Radioassay, angiotensin converting enzyme 33645 12 06 02 03 Angiotensin Converting Enzyme (IC) CC =>11.01.01.09
Automated urinalysis system 33646 21 01 10 01 CH Hardware + dedicated accessories + software
Galactose-1-phosphate kit 33647 14 02 05 90 Other Manual Susceptibility Testing
Copper sulfate solution 33671 13 01 09 90 Other Other Haematology Testing Reagents
Centrifuge, blood-bank for in vitro diagnostic use 33672 28 01 10 01 SP Hardware + accessories + software
Boxes, view, blood grouping 33673 23 03 10 01 BG Hardware + dedicated accessories + software
Carbonic anhydrase kit 33683 12 01 90 90 Other Other Plasma Proteins
Anti-DNA indirect immunofluorescent solid phase 33684 12 10 01 05 ds DNA - Antibodies
C3-indirect immunofluorescent solid phase 33685 12 01 02 03 Complement Component C3/C3c
System, test, infectious mononucleosis 33686 15 04 04 11 Mononucleosis Inf. Imm.=> 15 70 90 03
Reagent, immunoassay, IgG 33687 12 01 01 05 Immunoglobulin G
Complement C3b activator immunoassay reagent 33688 12 01 02 03 Complement Component C3/C3c
Radioimmunoassay, cholyglycine, bile acid 33713 11 02 01 02 Bile acids

Page 51 of 108
Radioimmunoassay, methaqualone 33730 12 09 01 11 Methaqualone

Enzyme immunoassay, digoxin 33731 12 08 01 01 Digoxin
Automated colony counter 33755 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Manual colony counter 33756 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Culture media, enriched 33759 14 01 03 04 Enrichment media (Bottles)
High pressure liquid chromatography, barbiturate 33762 12 09 01 03 Barbiturates
Gas chromatography, benzodiazipine 33763 12 09 01 04 Benzodiazepines
High pressure liquid chromatography, benzodiazipine 33764 12 09 01 04 Benzodiazepines
Thin layer chromatography, benzodiazipine 33765 12 09 01 04 Benzodiazepines
Gas chromatography, codeine 33766 12 09 01 07 Codeine
High pressure liquid chromatography, codeine 33767 12 09 01 07 Codeine
Gas chromatography, methamphetamine 33768 12 09 01 02 Amphetamine/Methamphetamine Specific (+Ecstasy)
Methamphetamine kit 33769 12 09 01 02 Amphetamine/Methamphetamine Specific (+Ecstasy)
High pressure liquid chromatography, opiates 33770 12 09 01 13 Opiates
Thin layer chromatography, opiates 33771 12 09 01 13 Opiates
Gas chromatography, propoxyphene 33772 12 09 01 15 Propoxyphene
High pressure liquid chromatography, propoxyphene 33773 12 09 01 15 Propoxyphene
Quinine kit 33774 12 08 01 09 Quinidine
Enzyme immunoassay, N-acetylprocainamide 33775 12 08 01 06 N-Acetylprocainamide
Enzyme immunoassay, methotrexate 33776 12 08 05 01 Methotrexate
Radioassay, methotrexate, enzyme 33777 12 08 05 01 Methotrexate
Radioimmunoassay, methotrexate 33778 12 08 05 01 Methotrexate
Enzyme immunoassay, procainamide 33779 12 08 01 07 Procainamide
Theophylline control material 33780 12 50 01 02 TDM/Drug Controls
Lidocaine control material 33781 12 50 01 02 TDM/Drug Controls
Methotrexate control material 33782 12 50 01 02 TDM/Drug Controls
N-acetylprocainamide control material 33783 12 50 01 02 TDM/Drug Controls
Procainamide control 33784 12 50 01 02 TDM/Drug Controls
Electrophoresis, cholesterol via esterase-oxidase, HDL 33798 11 02 01 34 Lipoprotein Electrophoresis
Radioimmunoassay, sisomicin 33801 12 08 03 07 Sisomycin
Enzyme immunoassay, quinidine 33802 12 08 01 09 Quinidine
Radioimmunoassay, theophylline 33803 12 08 04 02 Theophylline
Enzyme immunoassay, gentamicin 33805 12 08 03 04 Gentamicin
Tonometer (calibration and Q.C. of blood-gas instrument), clinical 33807 00 00 00 00 Not for IVD use
Thin layer chromatography, phencyclidine 33809 12 09 01 14 Phencyclidine
Radioimmunoassay, phencyclidine 33810 12 09 01 14 Phencyclidine
Enzyme immunoassay, phencyclidine 33811 12 09 01 14 Phencyclidine
Platelet factor 4 immunoassay 33813 13 02 04 02 Platelet Factor 4
Fluorescent immunoassay gentamicin 33814 12 08 03 04 Gentamicin
Fluorescent immunoassay, tobramycin 33815 12 08 03 09 Tobramycin

Page 52 of 108
Radioimmunoassay, digoxin (125-I) 33816 12 08 01 01 Digoxin

Radioimmunoassay, digoxin (3-H) 33817 12 08 01 01 Digoxin
Radioimmunoassay, digitoxin (125-I) 33818 12 08 01 02 Digitoxin
Human chorionic gonadotropin self-test kit 33819 12 70 05 02 HCG - Rapid Test
Enzyme immunoassay, cannabinoid 33825 12 09 01 05 Cannabinoids
Instrumentation, high pressure liquid chromatography 33826 21 05 10 02 HPLC Hardware + dedicated accessories + software
Enzymatic radiochemical assay, amikacin 33827 12 08 03 01 Amikacin
Enzymatic radiochemical assay, tobramycin 33828 12 08 03 09 Tobramycin
Fixative, acid 33831 13 07 01 05 Fixing reagents (Histology/Cytology)
Fixative, metallic 33832 13 07 01 05 Fixing reagents (Histology/Cytology)
Fixative, formalin 33833 13 07 01 05 Fixing reagents (Histology/Cytology)
Fixative, alcohol 33834 13 07 01 05 Fixing reagents (Histology/Cytology)
Mounting media 33835 13 07 01 06 Mounting media (Histology/Cytology)
Stain, chemical solution 33836 13 07 01 08 Stain solutions (Histology/Cytology)
Stain, dye solution 33837 13 07 01 08 Stain solutions (Histology/Cytology)
Stain, dye powder 33838 13 07 01 07 Stain powders (Histology/Cytology)
Enzyme immunoassay, valproic acid 33839 12 08 02 10 Valproic Acid
Radioimmunoassay, vancomycin 33840 12 08 03 10 Vancomycin
Fluorescent immunoassay, theophylline 33844 12 08 04 02 Theophylline
Fluorescent immunoassay, diphenylhydantoin 33845 12 08 02 90 Other Central Nervous System TDM
Fluorescent immunoassay, phenobarbital 33846 12 08 02 07 Phenobarbital
Thin layer chromatography, theophylline 33847 12 08 04 02 Theophylline
Radioimmunoassay, tricyclic antidepressant drugs 33852 12 09 02 15 Tricyclic Antidepressants (Total)
Enzyme immunoassay, digitoxin 33855 12 08 01 02 Digitoxin
Nephelometric inhibition immunoassay, phenobarbital 33856 12 08 02 07 Phenobarbital
Conductivity rate, urea nitrogen 33857 11 04 03 05 Urea - Electrodes
Glucose dehydrogenase, glucose 33858 11 02 01 13 Glucose
Fluorescent immunoassay, primidone 33859 12 08 02 09 Primidone
Enzyme linked immunoabsorbent assay, rubella 33860 15 04 01 04 Rubella Virus Antibodies - Total
Enzyme linked immunoabsorbent assay, varicella-zoster 33861 15 04 80 10 Varicella Zoster
Enzyme linked immunoabsorbent assay, cytomegalovirus 33862 15 04 02 04 CMV Antibodies - Total
Fluorescence polarization immunoassay, carbamazepine 33865 12 08 02 01 Carbamazepine
Assay, alpha-2-antiplasmin 33869 13 02 05 01 a2-Antiplasmin
Trypan blue 33871 14 01 08 02 Other Stains
Device, fertility diagnostic 33876 21 02 30 01 IC Consumables
Staphylococcus aureus protein A insoluble 33879 15 01 12 01 Staphylococcal Direct Antigen Detection
Antigen, ID, Candida albicans 33880 15 06 01 02 Candida albicans
Staphylococcus aureus somatic antigen 33887 15 01 12 01 Staphylococcal Direct Antigen Detection
T lymphocyte surface marker kit 33895 13 05 01 01 Antibodies for B and T-cell subtyping
Enzyme linked immunoabsorbent assay, rubeola 33896 15 04 01 04 Rubella Virus Antibodies - Total

Page 53 of 108
B lymphocyte marker kit 33897 13 05 01 01 Antibodies for B and T-cell subtyping

Electrode, in vivo calcium ion selective 33901 11 04 01 02 Calcium - Electrodes
Epstein-Barr virus immunoglobulin M kit 33902 15 04 04 04 EBV Antibodies
Antigen, IHA, cytomegalovirus 33903 15 04 02 01 CMV Antigen
Antiserum, fluorescent, Chlamydia trachomatis 33904 15 01 01 03 Chlamydia Antibody Assays Total
Test, urine leukocyte 33907 11 70 02 01 Urine Single Test Strips (incl. tablets)
Enzyme linked immunoabsorbent assay, mumps virus 33908 15 04 80 08 Mumps / Parotitis
Enzyme linked immunoabsorbent assay, Mycoplasma spp. 33909 15 01 08 03 Mycoplasma Antibody Assays
Antigen, indirect haemagglutination, Herpes spp. 33910 15 04 03 01 HSV Antigen
Antinuclear antibody, antigen, control 33913 12 10 01 01 ANA Screening
Alpha1-acid glycoprotein control 33914 12 01 90 01 a1-Acid Glycoprotein ( Orosomucoid )
Analyser, urine, particle counting 33915 21 01 10 01 CH Hardware + dedicated accessories + software
Anti-ribonucleoprotein antibody kit 33916 12 10 02 11 Anti-Ri Antibody
Anti-SM antibody, antigen and control 33917 12 10 01 11 Sm
Antibody IgM, IF, cytomegalovirus virus 33918 15 04 02 06 CMV IgM
Respiratory syncytial virus, antigen, antibody, IFA 33919 15 04 80 05 Respiratory Syncytial Virus (RSV)
Direct agglutination test, Toxoplasma gondii 33921 15 05 01 04 Toxoplasma Antibody (Total)
Kit, IgG, platelet associated 33925 12 01 01 05 Immunoglobulin G
Reagent, Clostridium difficile toxin 33926 15 01 90 02 Clostridium difficile
Extractable antinuclear antibody, antigen and control 33928 12 10 01 02 ENA Screening
Analyser, chromosome 33936 23 03 10 01 BG Hardware + dedicated accessories + software
System, test, oxalate 33940 11 02 01 23 Oxalate
DNA-reagent, Mycobacterium spp. 33943 15 01 07 40 Mycobacterial Detection by NA Reagents
DNA-reagent, Mycoplasma spp. 33944 15 01 08 40 Mycoplasma Detection by NA Reagents
DNA-reagent, Legionella 33945 15 01 05 40 Legionella Detection by NA Reagents
Latex agglutination assay, rubella 33947 15 04 01 04 Rubella Virus Antibodies - Total
Campylobacter Spp. 33948 15 01 14 01 Campylobacter Direct Antigen Detection
pH meter for dialysis hydrogen ion concentration 33955 00 00 00 00 Not for IVD use
Neisseria control 33970 15 50 01 01 Bacteriology Controls - Inf.Imm.
Epstein-barr virus, other 33971 15 04 04 90 Other EBV Reagents
DNA-reagent, Epstein-Barr virus 33972 15 04 04 40 EBV - NA Reagents
Candida species, antibody detection 33973 15 06 01 02 Candida albicans
Antigen, Blastomyces dermatitidis, other 33974 15 06 01 90 Other Mycology Immunoassays
Antiserum, Blastomyces dermatitidis, other 33975 15 06 01 90 Other Mycology Immunoassays
DNA-reagent, Neisseria 33977 15 01 40 11 Neisseria meningitidis - NA Reagents
DNA-reagent, Shigella spp. 33978 15 01 40 14 Shigella - NA Reagents
DNA-reagent, cytomegalovirus 33979 15 04 02 40 CMV - NA Reagents
Reagent, rickettsia serological 33980 15 01 90 05 Rickettsia
Cytokeratin 34007 12 03 01 20 CYFRA 21-1
Pneumocystis carinii 34008 14 05 02 01 Pneumocystis carinii

Page 54 of 108
Campylobacter pylori 34016 15 01 14 01 Campylobacter Direct Antigen Detection

DNA-probe, reagent, Histoplasma capsulatum 34044 15 06 01 90 Other Mycology Immunoassays
Antigen, C. difficile 34047 15 01 90 02 Clostridium difficile
DNA-probe, Haemophilus spp. 34048 15 01 40 10 Haemophilus influenzae - NA Reagents
DNA-probe, Staph aureus 34054 15 01 12 40 Staphylococci Detection by NA Reagents
DNA-probe, Strep pneumoniae 34055 15 01 11 40 Streptococci Detection by NA Reagents
System, blood culturing 34061 14 01 05 Blood Culture - Manual
DNA-probe, reagent, cryptococcal 34062 15 06 01 90 Other Mycology Immunoassays
DNA-probe, reagent, Coccidioides immitis 34063 15 06 01 90 Other Mycology Immunoassays
DNA-probe, reagent, streptococcal 34064 15 01 11 40 Streptococci Detection by NA Reagents
Elisa, Trichinella spiralis 34068 15 05 10 90 Other Parasitology
Antigen, ELISA, Cryptococcus 34069 15 06 01 90 Other Mycology Immunoassays
Alpha-1 microglobulin, antigen, antiserum, control 34080 12 01 90 04 a1-Microglobulin
Prothrombin fragment 1.2 34088 13 02 03 08 Prothrombin Fragment 1 + 2
Isoniazid test strip 34089 12 08 03 90 Other Antibiotics TDM
Immunofluorescent assay, T. cruzi 34093 15 05 10 02 Chagas
Susceptibility test powders, antimycobacterial 34095 14 02 05 04 Mycobacteria Susceptibility Testing
Culture medium, antifungal, susceptibility test 34098 14 03 06 Susceptibility Testing (Mycology)
DNA probe, Trichomonas vaginalis 34102 15 05 10 90 Other Parasitology
EIA, Blastomyces dermatitidis 34103 15 06 01 90 Other Mycology Immunoassays
DNA probe, Gardnerella vaginalis 34104 15 05 10 90 Other Parasitology
Enzyme immunoassay, foetal fibronectin 34111 12 01 90 05 Fibronectin
DNA probe, nucleic acid amplification, Chlamydia 34113 15 01 01 40 Chlamydia Detection by NA Reagents
DNA probe, yeast 34114 15 06 01 90 Other Mycology Immunoassays
Enzyme immunoassay, antiparietal cell antibody, antigen, control 34117 12 10 90 11 Parietal Cell Antibodies
Haemoglobin C, abnormal haemoglobin variant 34118 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
Immunoassay method, troponin subunit 34126 12 13 01 07 Troponin (T + I)
Device, semen analysis 34135 21 02 10 01 IC Hardware + dedicated accessories + software
Irradiator, blood to prevent graft versus host disease 34156 00 00 00 00 Not for IVD use
Anti-ribosomal P antibody kit 34166 12 10 90 20 Ribosomal Phosphoprotein Antibodies
B/T lymphocyte nucleic acid kit 34183 13 05 01 01 Antibodies for B and T-cell subtyping
Interleukin kit 34184 13 06 01 11 Interleukins (IL-1,IL-1A,IL-1B,.. - IL-15)
Human chromosome nucleic acid kit 34185 16 01 03 Chromosomal Disorders
Test, squamous cell carcinoma 34186 12 03 01 35 Squamous Cell Carcinoma Antigen
Kit, DNA detection, human papillomavirus 34187 15 04 40 03 Human Papilloma Virus - NA Reagents
Sensor, glucose, invasive 34220 11 04 03 02 Glucose - Electrodes
Kit, RIA, myelin basic protein 34224 12 10 02 07 Anti-MAG (Myelin Associated Glycoprotein)
Sialic acid kit 34225 11 02 01 90 Other Substrates
Prostatic acid phosphatase kit 34226 12 03 01 37 Prostatic Acid Phosphatase (IC) CC =>11.01.01.02
Patient monitor, blood gas, transcutaneous 34381 21 07 10 01 Diabetes Management Hardware + dedicated accessories + software

Page 55 of 108
Clinical chemistry test equipment 34546 21 01 10 01 CH Hardware + dedicated accessories + software

Clinical chemistry automated analyser 34547 21 01 10 01 CH Hardware + dedicated accessories + software
Centrifugal clinical chemistry automated analyser 34548 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, clinical chemistry, dry 34549 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, clinical chemistry, packed 34550 21 01 10 01 CH Hardware + dedicated accessories + software
Clinical spectrophotometer 34551 21 01 10 01 CH Hardware + dedicated accessories + software
Electrolyte analyser 34552 21 04 10 01 GE Hardware + dedicated accessories + software
Flame photometer electrolyte analyser 34553 21 04 10 01 GE Hardware + dedicated accessories + software
Coulometric electrolyte analyser 34554 21 04 10 01 GE Hardware + dedicated accessories + software
Analyser, electrolyte, fluorometric 34555 21 04 10 01 GE Hardware + dedicated accessories + software
Protein fraction electrophoresis instrument 34556 21 05 10 01 EP Hardware + dedicated accessories + software
Immunophotometric instrument 34557 21 02 10 01 IC Hardware + dedicated accessories + software
Immunoturbidimetric instrument 34558 21 02 10 01 IC Hardware + dedicated accessories + software
Immunofluorometric instrument 34559 21 02 10 01 IC Hardware + dedicated accessories + software
Lactate analyser 34560 21 01 10 01 CH Hardware + dedicated accessories + software
Liquid chromatograph, special purpose 34561 21 05 10 02 HPLC Hardware + dedicated accessories + software
Electrical resistance type blood cell counter 34562 23 01 10 01 CC Hardware + dedicated accessories + software
Blood coagulation analyser 34563 23 02 10 01 HS Hardware + dedicated accessories + software
Erythrocyte sedimentation rate test instrument 34564 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Cell analyser 34565 23 01 10 01 CC Hardware + dedicated accessories + software
Nuclear medical test instrument 34566 26 01 10 01 NA Hardware + dedicated accessories + software
Medical specimen pre-treatment instrument 34568 28 01 10 01 SP Hardware + accessories + software
Medical centrifuge 34569 28 01 10 01 SP Hardware + accessories + software
Accessory, medical specimen pre-treatment instrument 34570 28 01 10 01 SP Hardware + accessories + software
Urine gravimeter 34571 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, microbiology 34572 24 01 10 01 SI Hardware + dedicated accessories + software
Analyser, microbiology, microbe identification 34573 24 01 10 01 SI Hardware + dedicated accessories + software
Analyser, microbiology, antibiotic susceptibility 34574 24 01 10 01 SI Hardware + dedicated accessories + software
Automated histological analysis instrument 34575 23 05 10 01 HC Hardware + dedicated accessories + software
Centrifuge, microhaematocrit 34932 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Centrifuge, table-top 34933 28 01 10 01 SP Hardware + accessories + software
Analyser, haematology, cell-quantifying, manual 35103 23 01 10 01 CC Hardware + dedicated accessories + software
Analyser, alcohol 35464 21 07 10 09 Other RT_CI Hardware + dedicated accessories + software
Antibiotic susceptibility analyser 35465 24 01 10 01 SI Hardware + dedicated accessories + software
Blood urea nitrogen analyser 35466 21 01 10 01 CH Hardware + dedicated accessories + software
Coagulation analyser, automated 35468 23 02 10 01 HS Hardware + dedicated accessories + software
Analyser, electrolyte, <specify> 35469 21 04 10 01 GE Hardware + dedicated accessories + software
Analyser, enzyme 35470 21 01 10 01 CH Hardware + dedicated accessories + software
Glucose analyser, laboratory 35471 21 01 10 01 CH Hardware + dedicated accessories + software
Nitrogen analyser 35472 21 01 10 01 CH Hardware + dedicated accessories + software

Page 56 of 108
Analyser, haematology, platelet aggregation 35473 23 02 10 01 HS Hardware + dedicated accessories + software

Analyser, bilirubinometry 35475 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, haematology, cell-quantifying, automated 35476 23 01 10 01 CC Hardware + dedicated accessories + software
Information system, clinical laboratory 35477 29 01 10 01 Other Hardware + dedicated accessories + software
Analyser, haematology, cell-differential 35479 23 01 10 01 CC Hardware + dedicated accessories + software
Dispenser, slides 35480 23 05 30 01 HC Consumables
Analyser, haematology, haemoglobin 35481 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Pump, laboratory, high-pressure 35485 00 00 00 00 Not for IVD use
Analyser, haematology, sedimentation rate 35488 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
View box, Rh typing 35490 23 03 10 01 BG Hardware + dedicated accessories + software
Analyser, immunoassay, radio-isotopic 35506 21 02 10 01 IC Hardware + dedicated accessories + software
Analyser, clinical chemistry, <specify> 35513 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, haematology, coagulation 35514 23 02 10 01 HS Hardware + dedicated accessories + software
Blood gas/pH analyser 35551 21 04 10 01 GE Hardware + dedicated accessories + software
Centrifuge tube adaptor 35554 28 01 10 01 SP Hardware + accessories + software
Analyser, blood potassium 35566 21 04 10 01 GE Hardware + dedicated accessories + software
Helium analyser 35603 00 00 00 00 Not for IVD use
Analyser, blood culture, automated 35617 24 02 10 01 BC & MB Hardware + dedicated accessories + software
Cell size analyser 35627 23 01 10 01 CC Hardware + dedicated accessories + software
Analyser, haematology, blood grouping 35635 23 03 10 01 BG Hardware + dedicated accessories + software
Analyser, immunoassay, enzyme 35706 21 02 10 01 IC Hardware + dedicated accessories + software
Analyser, immunoassay, fluorescent 35707 21 02 10 01 IC Hardware + dedicated accessories + software
Dispenser, disk, antimicrobial susceptibility test 35733 24 01 30 01 SI Consumables
Dispenser, liquid, laboratory, manually-operated 35734 28 01 10 01 SP Hardware + accessories + software
View box, ultraviolet 35736 23 03 10 01 BG Hardware + dedicated accessories + software
Clinical chemistry analyser, automated 35742 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, clinical chemistry, automated, discrete 35743 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, clinical chemistry, centrifugal 35744 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, clinical chemistry, flow 35745 21 01 10 01 CH Hardware + dedicated accessories + software
Clinical chemistry analyser, manual 35746 21 01 10 01 CH Hardware + dedicated accessories + software
Recorder, graphic, platelet aggregation 35769 23 02 10 01 HS Hardware + dedicated accessories + software
Haematofluorometer 35770 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Urine analyser, automated 35772 21 01 10 01 CH Hardware + dedicated accessories + software
Radioimmunoassay analyser, automated 35773 21 02 10 01 IC Hardware + dedicated accessories + software
Radioimmunoassay analyser, semiautomated 35774 21 02 10 01 IC Hardware + dedicated accessories + software
Diluter, blood 35781 23 01 30 01 CC Consumables
Analyser, electrolyte, flame photometer 35826 21 04 10 01 GE Hardware + dedicated accessories + software
Analyser, photometer, reflectance 35827 21 07 10 09 Other RT_CI Hardware + dedicated accessories + software
Analyser, haematology, cell-analysis 35835 23 01 10 01 CC Hardware + dedicated accessories + software
Centrifuge, cytology 35881 28 01 10 01 SP Hardware + accessories + software

Page 57 of 108
Analyser, lactate 35885 21 01 10 01 CH Hardware + dedicated accessories + software

Centrifuge, cell washing 35901 28 01 10 01 SP Hardware + accessories + software
Analyser, ion selective 35902 21 04 10 01 GE Hardware + dedicated accessories + software
Analyser, electrolyte, coulometric 35903 21 04 10 01 GE Hardware + dedicated accessories + software
Radioimmunoassay analyser, manual 35914 21 02 10 01 IC Hardware + dedicated accessories + software
Analyser, urine 35918 21 01 10 01 CH Hardware + dedicated accessories + software
Urine analyser, semi-automated 35919 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, immunoassay, light transmission 35926 21 02 10 01 IC Hardware + dedicated accessories + software
Blood gas calibrator 35933 11 50 90 01 Blood gas control
Analyser, calcium 35937 21 04 10 01 GE Hardware + dedicated accessories + software
Semen analyser 35949 21 02 10 01 IC Hardware + dedicated accessories + software
Culture medium, mycology 35960 14 03 Mycology
Culture medium, viral cultivation/identification 35962 14 04 Viral Culture
Decalcifying reagent 35963 13 02 80 90 Other Auxiliary Reagents (Haemostasis)
Analyser, haematology, glycohaemoglobin 35968 21 07 10 01 Diabetes Management Hardware + dedicated accessories + software
Analyser, catecholamine 35989 21 02 10 01 IC Hardware + dedicated accessories + software
Coagulation analyser, semi-automated 35990 23 02 10 01 HS Hardware + dedicated accessories + software
Analyser, creatinine 35991 21 01 10 01 CH Hardware + dedicated accessories + software
Alpha1-acid glycoprotein kit 36010 12 01 90 01 a1-Acid Glycoprotein ( Orosomucoid )
Reagent, alpha foetoprotein 36011 12 03 90 01 Alphafetoprotein
Reagent, anti-DNA antibody 36012 12 10 01 05 ds DNA - Antibodies
Reagent, Legionella spp. 36013 15 01 05 01 Legionella Antigen Detection
Myelin basic protein kit 36014 12 10 02 07 Anti-MAG (Myelin Associated Glycoprotein)
Reagent, haemopexin 36015 12 01 03 04 Haemopexin
Hepatitis B virus/e antigen/antibody kit 36017 15 02 02 24 Hepatitis Be Antibody (Total)
Reagent, heterophile, infectious mononucleosis, antibody 36018 15 04 04 11 Mononucleosis Inf. Imm.=> 15 70 90 03
Properdin factor B kit 36019 12 01 02 90 Other Complement Components
Culture medium, enriched 36030 14 01 03 04 Enrichment media (Bottles)
Analyser, alcohol, breath 36041 21 07 10 09 Other RT_CI Hardware + dedicated accessories + software
Analyser, physiologic, fertility, thermometric 36110 00 00 00 00 Not for IVD use
Analyser, haematology, <specify> 36156 23 01 10 01 CC Hardware + dedicated accessories + software
Haematology analyser, automated 36157 23 01 10 01 CC Hardware + dedicated accessories + software
Haematology analyser, semiautomated 36158 23 01 10 01 CC Hardware + dedicated accessories + software
Giardia lamblia kit 36173 15 05 10 08 Giardia lamblia
Culture medium, transport 36214 14 01 02 20 Transport Media (Tubes)
Analyser, immunoassay, chemiluminescent 36223 21 02 10 01 IC Hardware + dedicated accessories + software
Protective barrier strike-through detector 36248 00 00 00 00 Not for IVD use
Reagent, prostate, specific antigen, PSA 36300 12 03 01 32 Total Prostatic Specific Antigen
Bath, wax 36329 00 00 00 00 Not for IVD use
Analyser, blood gas, transcutaneous 36346 21 04 10 01 GE Hardware + dedicated accessories + software

Page 58 of 108
Analyser, fluorescence 36396 21 04 10 01 GE Hardware + dedicated accessories + software

Analyser, chromatograph, <specify> 36404 21 05 10 02 HPLC Hardware + dedicated accessories + software
Laboratory equipment, washer, cell 36407 28 01 10 01 SP Hardware + accessories + software
Laboratory equipment, diluter 36408 28 01 10 01 SP Hardware + accessories + software
Analyser, photometer, atomic absorption 36409 21 04 10 01 GE Hardware + dedicated accessories + software
Analyser, photometer, <specify> 36411 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, photometer, flame emission 36413 21 04 10 01 GE Hardware + dedicated accessories + software
Analyser, chromatograph, gas 36414 00 00 00 00 Not for IVD use
Analyser, photometer, luminescence 36415 21 02 10 01 IC Hardware + dedicated accessories + software
Casting unit, laboratory, paraffin 36416 13 07 01 04 Embedding media (Histology/Cytology)
Alcoholmeter 36417 23 07 10 01 RT_HHC Hardware + dedicated accessories + software
Laboratory equipment, incubator CO2 36418 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Analyser, chromatograph, high-pressure liquid chromatography 36420 21 05 10 02 HPLC Hardware + dedicated accessories + software
Analyser, calorimeter 36421 00 00 00 00 Not for IVD use
Laboratory equipment, microtome freezer 36443 23 05 10 01 HC Hardware + dedicated accessories + software
Laboratory equipment, microtome ultra 36444 23 05 10 01 HC Hardware + dedicated accessories + software
Laboratory equipment, microtome general-purpose 36447 23 05 10 01 HC Hardware + dedicated accessories + software
Analyser, osmometric 36458 00 00 00 00 Not for IVD use
Analyser, titration 36459 00 00 00 00 Not for IVD use
Laboratory equipment, centrifuge refrigerated 36460 28 01 10 01 SP Hardware + accessories + software
Ultracentrifuge 36461 28 01 10 01 SP Hardware + accessories + software
Centrifuge, general-purpose laboratory 36465 28 01 10 01 SP Hardware + accessories + software
Scanning light densitometer 36604 21 05 10 01 EP Hardware + dedicated accessories + software
Blood culture analyser, automated 36722 24 02 10 01 BC & MB Hardware + dedicated accessories + software
Analyser, amino acid 36724 21 02 10 01 IC Hardware + dedicated accessories + software
Analyser, blood glucose 36730 21 01 10 01 CH Hardware + dedicated accessories + software
Glycohaemoglobin analyser 36734 21 07 10 01 Diabetes Management Hardware + dedicated accessories + software
Calcium analyser 36736 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, chloride 36738 21 04 10 01 GE Hardware + dedicated accessories + software
Analyser, nitrogen 36741 00 00 00 00 Not for IVD use
Analyser, sperm/semen 36744 21 02 10 01 IC Hardware + dedicated accessories + software
Analyser, haematology, thrombosis 36746 23 02 10 01 HS Hardware + dedicated accessories + software
Analyser, viscosimetric 36823 00 00 00 00 Not for IVD use
Analyser, multichannel 36839 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, photometer, general-purpose 36910 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, chromatograph HPLC, compact 36929 21 05 10 02 HPLC Hardware + dedicated accessories + software
Laboratory equipment, bunsen burner 36934 00 00 00 00 Not for IVD use
Analyser, photometer multifunction 36942 21 01 10 01 CH Hardware + dedicated accessories + software
Analyser, fluorescence immunoassay automatic 36944 21 02 10 01 IC Hardware + dedicated accessories + software
Laboratory equipment, centrifuge vacuum 36988 28 01 10 01 SP Hardware + accessories + software

Page 59 of 108
Laboratory equipment, refractometer 36992 00 00 00 00 Not for IVD use

Thermostat, laboratory 37028 00 00 00 00 Not for IVD use
Laboratory equipment, pump, high-pressure 37033 00 00 00 00 Not for IVD use
Analyser, microtitre plate reader 37036 21 02 10 01 IC Hardware + dedicated accessories + software
Analyser, tensiometric 37056 00 00 00 00 Not for IVD use
Analyser, blood sedimentation 37058 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Analyser, gas, helium 37063 00 00 00 00 Not for IVD use
Light-box, ultraviolet 37073 00 00 00 00 Not for IVD use
Analyser, haemoximetric 37078 00 00 00 00 Not for IVD use
Analyser, blood gas, subcutaneous 37199 21 04 10 01 GE Hardware + dedicated accessories + software
Blood irradiator 37211 00 00 00 00 Not for IVD use
Laboratory equipment, centrifuge cyto 37214 28 01 10 01 SP Hardware + accessories + software
Dialyser, analyser blood volume 37218 00 00 00 00 Not for IVD use
Analyser, blood gas, <specify> 37237 21 04 10 01 GE Hardware + dedicated accessories + software
Analyser, gas, hydrogen 37252 00 00 00 00 Not for IVD use
Vitamin D kit, <specify> 37260 12 06 03 10 25-Hydroxyvitamin D3
Test system, nicotine, cotinine, metabolites 37270 12 09 01 08 Cotinine
Apolipoprotein kit 37281 12 01 04 21 Lipoprotein ( a )
Prostate specific antigen kit 37286 12 03 01 32 Total Prostatic Specific Antigen
Free prostate specific antigen kit 37287 12 03 01 33 Free Prostatic Specific Antigen
Human immunodeficiency virus sample collection kit 37288 25 01 30 01 II Consumables
Reagent, thrombin 37289 13 02 01 03 Thrombin Time / Reptilase / Batroxobin Time
Test, syphilis, treponemal 37290 15 01 03 03 Syphilis Antibody Assays Total
Antibody, HTLV-1, ELISA 37291 15 03 30 04 HTLV I Antibody
Centrifuge rotor, ultracentrifuge 37530 28 01 10 01 SP Hardware + accessories + software
Centrifuge rotor, adjustable angle 37531 28 01 10 01 SP Hardware + accessories + software
Centrifuge rotor, fixed angle 37532 28 01 10 01 SP Hardware + accessories + software
Centrifuge rotor, swinging bucket 37533 28 01 10 01 SP Hardware + accessories + software
Laboratory equipment, casting unit, paraffin wax 37537 23 05 10 01 HC Hardware + dedicated accessories + software
Titrator 37573 00 00 00 00 Not for IVD use
ACT meter 37702 23 02 10 01 HS Hardware + dedicated accessories + software
Culture medium, <specify> 37711 14 01 01 01 DCM (except susceptibility testing)
Atomic absorption spectroscopy kit, <specify> 37719 11 03 01 90 Other Electrolytes
Haemopexin control 37720 12 50 01 06 Specific Protein Controls
Albumin control 37721 12 01 03 01 Albumin (IC) incl. uAlbumin CC =>11.02.01.01
Bordetella pertussis kit 37723 15 01 90 07 Bordetella pertussis / parapertussis
Anti-deoxyribonucleic acid antibody kit 37724 12 10 01 05 ds DNA - Antibodies
Anti-smooth muscle antibody kit 37725 12 10 01 11 Sm
Shigella kit 37726 15 01 90 14 Shigella
Escherichia coli kit 37727 15 01 15 01 E. Coli Direct Antigen Detection

Page 60 of 108
Echovirus kit 37728 15 04 80 90 Other Viral Antigen/Antibody Detection

Coxsackievirus kit 37729 15 04 80 90 Other Viral Antigen/Antibody Detection
Equine encephalitis kit 37730 15 04 80 90 Other Viral Antigen/Antibody Detection
Poliovirus kit 37731 15 04 80 90 Other Viral Antigen/Antibody Detection
Reovirus kit 37732 15 04 80 90 Other Viral Antigen/Antibody Detection
Treponema total antibody control 37733 15 50 01 01 Bacteriology Controls - Inf.Imm.
Histoplasma capsulatum kit 37734 15 01 90 90 Other Other Bacteriology Immunoassays
Francisella tularensis kit 37735 15 05 10 90 Other Parasitology
Trichinella spiralis kit 37736 15 06 01 90 Other Mycology Immunoassays
Blastomyces dermatitidis kit 37737 15 06 01 90 Other Mycology Immunoassays
Parapertussis kit 37738 15 01 90 07 Bordetella pertussis / parapertussis
Coccidioides immitis kit 37739 15 06 01 90 Other Mycology Immunoassays
Mumps virus kit 37740 15 04 80 08 Mumps / Parotitis
Aspergillus kit 37741 15 06 01 01 Aspergillus
Lymphocytic choriomeningitis virus kit 37742 15 04 80 13 LCM Virus
Trypanosoma cruzi kit 37745 15 05 10 02 Chagas
Cryptococcus neoformans kit 37746 15 06 01 90 Other Mycology Immunoassays
Erysipelothrix rhusiopathiae kit 37747 15 01 90 90 Other Other Bacteriology Immunoassays
Candida kit 37748 15 06 01 02 Candida albicans
Neisseria kit 37750 15 01 90 11 Neisseria meningitidis
Haemophilus kit 37751 15 01 90 10 Haemophilus influenzae
Klebsiella kit 37752 15 01 90 90 Other Other Bacteriology Immunoassays
Proteus kit 37753 15 01 90 12 Proteus
Corynebacterium kit 37755 15 01 90 08 Diphteria (Corynebacterium D.)
Antistreptolysin kit 37756 12 11 01 04 Anti-Streptolysin (quantitative)
Antistaphylolysin kit 37757 12 11 01 06 Anti-Staphylolysin (qualititative)
Campylobacter kit 37758 15 01 14 01 Campylobacter Direct Antigen Detection
Gardnerella vaginalis kit 37759 15 05 10 90 Other Parasitology
Fab fragment control 37760 12 50 01 06 Specific Protein Controls
FC fragment control 37761 12 50 01 06 Specific Protein Controls
Gamma globulin control 37762 12 50 01 06 Specific Protein Controls
Immunoglobulin E control 37763 12 50 01 06 Specific Protein Controls
Antiparietal cell antibody kit 37765 12 10 90 11 Parietal Cell Antibodies
Bacillus subtilis kit 37766 14 02 03 01 Serotyping (E.coli, Salmonella, Shigella, etc.)
Rabies virus kit 37767 15 04 80 90 Other Viral Antigen/Antibody Detection
Pipette, electronic, multifunction 37926 00 00 00 00 Not for IVD use
Analyser, aqueous/flare cell 37948 00 00 00 00 Not for IVD use
Slide stainer, cytology 37974 23 05 10 01 HC Hardware + dedicated accessories + software
Slide stainer, manual 37975 23 05 10 01 HC Hardware + dedicated accessories + software
Alphafoetoprotein control 38166 12 50 01 10 Tumour Marker Controls

Page 61 of 108
Alphafoetoprotein calibrator 38167 12 50 01 09 Tumour Marker Standards / Calibrators

Serotonin kit 38169 12 03 90 17 Serotonine
5-hydroxyindoleacetic acid control 38170 12 50 01 10 Tumour Marker Controls
5-hydroxyindoleacetic acid calibrator 38171 12 50 01 09 Tumour Marker Standards / Calibrators
Carcinoembryonic antigen control 38173 12 50 01 10 Tumour Marker Controls
Carcinoembryonic antigen calibrator 38174 12 50 01 09 Tumour Marker Standards / Calibrators
Cathepsin-D control 38175 12 50 01 10 Tumour Marker Controls
Cathepsin-D calibrator 38176 12 50 01 09 Tumour Marker Standards / Calibrators
Cytokeratin fragment 19 control 38177 12 50 01 10 Tumour Marker Controls
Cytokeratin fragment 19 calibrator 38178 12 50 01 09 Tumour Marker Standards / Calibrators
Oestrogen receptor assay 38179 12 03 02 01 Estrogen Receptor Assays
Oestrogen receptor control 38180 12 50 01 10 Tumour Marker Controls
Oestrogen receptor calibrator 38181 12 50 01 09 Tumour Marker Standards / Calibrators
Free prostate specific antigen control 38182 12 50 01 10 Tumour Marker Controls
Free prostate specific antigen calibrator 38183 12 50 01 09 Tumour Marker Standards / Calibrators
Human placental alkaline phosphatase control 38184 12 50 01 10 Tumour Marker Controls
Human placental alkaline phosphatase calibrator 38185 12 50 01 09 Tumour Marker Standards / Calibrators
Laminin control 38186 12 50 01 10 Tumour Marker Controls
Laminin calibrator 38187 12 50 01 09 Tumour Marker Standards / Calibrators
Mucin-like carcinoma-associated antigen control 38188 12 50 01 10 Tumour Marker Controls
Mucin-like carcinoma-associated antigen calibrator 38189 12 50 01 09 Tumour Marker Standards / Calibrators
Neuron specific enolase control 38190 12 50 01 10 Tumour Marker Controls
Neuron specific enolase calibrator 38191 12 50 01 09 Tumour Marker Standards / Calibrators
Oncogene deoxyribonucleic acid probe control 38192 12 50 01 10 Tumour Marker Controls
Oncogene deoxyribonucleic acid probe calibrator 38193 12 50 01 09 Tumour Marker Standards / Calibrators
Oncogene protein control 38194 12 50 01 10 Tumour Marker Controls
Oncogene protein calibrator 38195 12 50 01 09 Tumour Marker Standards / Calibrators
Prostatic acid phosphatase control 38196 12 50 01 10 Tumour Marker Controls
Prostatic acid phosphatase calibrator 38197 12 50 01 09 Tumour Marker Standards / Calibrators
Progesterone receptor control 38198 12 50 01 10 Tumour Marker Controls
Progesterone receptor calibrator 38199 12 50 01 09 Tumour Marker Standards / Calibrators
Squamous cell carcinoma antigen control 38200 12 50 01 10 Tumour Marker Controls
Squamous cell carcinoma antigen calibrator 38201 12 50 01 09 Tumour Marker Standards / Calibrators
Thymidine kinase control 38202 12 50 01 10 Tumour Marker Controls
Thymidine kinase calibrator 38203 12 50 01 09 Tumour Marker Standards / Calibrators
TPA 38204 12 03 01 36 Tumor Polypeptide Antigen (TPA - incl. TPS)
Tissue polypeptide antigen control 38205 12 50 01 10 Tumour Marker Controls
Tissue polypeptide antigen calibrator 38206 12 50 01 09 Tumour Marker Standards / Calibrators
Prostate specific antigen control 38207 12 50 01 10 Tumour Marker Controls
Prostate specific antigen calibrator 38208 12 50 01 09 Tumour Marker Standards / Calibrators

Page 62 of 108
Bladder tissue antigen control 38209 12 50 01 10 Tumour Marker Controls

Bladder tissue antigen calibrator 38210 12 50 01 09 Tumour Marker Standards / Calibrators
Bladder tumour antigen 38212 12 03 01 01 Bladder Tissue Antigen
BTA, rapid test 38213 12 70 03 01 BTA - Rapid Test
Beta2-microglobulin control 38214 12 50 01 06 Specific Protein Controls
Beta2-microglobulin calibrator 38215 12 50 01 05 Specific Protein Standards / Calibrators
Faecal occult blood kit 38217 12 03 90 04 Fecal Occult Blood (IC) CC =>11.70.03.01
Faecal occult blood control 38218 12 50 01 10 Tumour Marker Controls
Faecal occult blood calibrator 38219 12 50 01 09 Tumour Marker Standards / Calibrators
Tissue-associated protein control 38220 12 50 01 06 Specific Protein Controls
Tissue-associated protein calibrator 38221 12 50 01 05 Specific Protein Standards / Calibrators
Cancer antigen 15-3 control 38222 12 50 01 10 Tumour Marker Controls
Cancer antigen 15-3 calibrator 38223 12 50 01 09 Tumour Marker Standards / Calibrators
Cancer antigen 50 control 38226 12 50 01 10 Tumour Marker Controls
Cancer antigen 50 calibrator 38227 12 50 01 09 Tumour Marker Standards / Calibrators
P53 kit 38238 12 03 03 02 p53
P53 control 38239 12 50 01 10 Tumour Marker Controls
P53 calibrator 38240 12 50 01 09 Tumour Marker Standards / Calibrators
Vitamin D control, 1-25-dihydroxyvitamin D3 38242 12 50 01 12 Anaemia Related/Vitamin Controls
Vitamin D calibrator, 1-25-dihydroxyvitamin D3 38243 12 50 01 11 Anaemia Related/Vitamin Standards and Calibrators
Luteinizing hormone kit 38246 12 05 01 05 Luteinising Hormone
Luteinizing hormone control 38247 12 50 01 04 Hormone Controls
Oestradiol control 38248 12 50 01 04 Hormone Controls
Oestradiol calibrator 38249 12 50 01 03 Hormone Standards / Calibrators
Oestriol control 38250 12 50 01 04 Hormone Controls
Oestriol calibrator 38251 12 50 01 03 Hormone Standards / Calibrators
Oestrone control 38252 12 50 01 04 Hormone Controls
Oestrone calibrator 38253 12 50 01 03 Hormone Standards / Calibrators

Page 63 of 108
Follicle stimulating hormone control 38254 12 50 01 04 Hormone Controls

Follicle stimulating hormone calibrator 38255 12 50 01 03 Hormone Standards / Calibrators
Free oestriol control 38256 12 50 01 04 Hormone Controls
Free oestriol calibrator 38257 12 50 01 03 Hormone Standards / Calibrators
Free thyroxine control 38258 12 50 01 04 Hormone Controls
Free thyroxine calibrator 38259 12 50 01 03 Hormone Standards / Calibrators
Free triiodothyronine calibrator 38261 12 50 01 03 Hormone Standards / Calibrators
Total human chorionic gonadotrophin control 38262 12 50 01 04 Hormone Controls
Total human chorionic gonadotrophin calibrator 38263 12 50 01 03 Hormone Standards / Calibrators
Beta-human chorionic gonadotropin control 38265 12 50 01 04 Hormone Controls
Beta-human chorionic gonadotropin calibrator 38266 12 50 01 03 Hormone Standards / Calibrators
Human placental lactogen control 38268 12 50 01 04 Hormone Controls
Human placental lactogen calibrator 38269 12 50 01 03 Hormone Standards / Calibrators
Luteinizing hormone calibrator 38270 12 50 01 03 Hormone Standards / Calibrators
Thyroid stimulating hormone control 38271 12 50 01 04 Hormone Controls
Thyroid stimulating hormone calibrator 38272 12 50 01 03 Hormone Standards / Calibrators
Thyroxine binding globulin control 38273 12 50 01 04 Hormone Controls
Thyroxine binding globulin calibrator 38274 12 50 01 03 Hormone Standards / Calibrators
Listeria antigen kit 38277 15 01 13 11 Listeria Monocytogenes direct Antigen detection
Listeria nucleic acid kit 38278 15 01 13 40 Listeria Detection by NA Reagents
Listeria antibody kit 38279 15 01 13 13 Listeria Monocytogenes Antibody assays
Chlamydia antigen control 38280 15 50 01 01 Bacteriology Controls - Inf.Imm.
Chlamydia immunoglobulin A control 38281 15 50 01 01 Bacteriology Controls - Inf.Imm.
Chlamydia immunoglobulin M control 38282 15 50 01 01 Bacteriology Controls - Inf.Imm.
Chlamydia immunoglobulin G control 38283 15 50 01 01 Bacteriology Controls - Inf.Imm.
Chlamydia total antibody control 38284 15 50 01 01 Bacteriology Controls - Inf.Imm.
Chlamydia nucleic acid control 38285 15 50 01 01 Bacteriology Controls - Inf.Imm.
Chlamydia total antibody calibrator 38286 15 50 01 01 Bacteriology Controls - Inf.Imm.
Chlamydia antigen calibrator 38287 15 50 01 01 Bacteriology Controls - Inf.Imm.
Chlamydia immunoglobulin A calibrator 38288 15 50 01 01 Bacteriology Controls - Inf.Imm.
Chlamydia immunoglobulin G calibrator 38289 15 50 01 01 Bacteriology Controls - Inf.Imm.
Chlamydia immunoglobulin M calibrator 38290 15 50 01 01 Bacteriology Controls - Inf.Imm.
Chlamydia nucleic acid calibrator 38291 15 50 01 01 Bacteriology Controls - Inf.Imm.
Clostridium difficile control 38292 15 50 01 01 Bacteriology Controls - Inf.Imm.
Clostridium difficile calibrator 38293 15 50 01 01 Bacteriology Controls - Inf.Imm.
Cytomegalovirus immunoglobulin M control 38294 15 50 01 04 Other Virology Controls - Inf.Imm.
Acid phosphatase total activity kit 38498 11 01 01 02 Acid Phosphatase (CC) IC => 12.03.01.37
Aspartate aminotransferase total activity kit 38499 11 01 01 10 Aspartate Amino-Transferase
Amylase kit 38502 11 01 01 07 Amylase - Total
Creatine kinase total activity kit 38503 11 01 01 13 Creatine Kinase - Total

Page 64 of 108
Lactate dehydrogenase total activity kit 38504 11 01 01 19 Lactate Dehydrogenase L ( LDH - L --> P )
Lipase kit 38505 11 01 01 23 Lipase
Cholinesterase kit 38506 11 01 01 11 Cholinesterase
Gamma-glutamyl transpeptidase kit 38507 11 01 01 16 Gamma Glutamyltransferase
Alkaline phosphatase isoenzyme kit 38511 11 01 01 06 Alkaline Phosphatase Isoenzymes(CC) IC => 12.06.03.01
Creatine kinase isoenzyme activity kit 38512 11 01 01 15 Creatine Kinase Isoenzymes
Electrode, ion-selective, uric acid 38519 11 04 03 90 Other Substrate - Electrodes / Biosensors
Free fatty acids 38520 11 02 01 22 Non Esterified Fatty Acids
Pipette, manually-operated 38522 00 00 00 00 Not for IVD use
Ethanol test strip 38524 12 70 09 90 Other Drugs of Abuse/Toxicology Rapid Tests
Alcohol control 38527 12 50 01 02 TDM/Drug Controls
Magnesium electrode 38531 11 04 01 05 Magnesium - Electrodes
Digoxin control 38532 12 50 01 02 TDM/Drug Controls
Digitoxin control 38533 12 50 01 02 TDM/Drug Controls
Lidocaine control 38534 12 50 01 02 TDM/Drug Controls
Methotrexate control 38535 12 50 01 02 TDM/Drug Controls
N-acetylprocainamide control 38536 12 50 01 02 TDM/Drug Controls
Theophylline control 38537 12 50 01 02 TDM/Drug Controls
Aldolase kit 38538 11 01 01 04 Aldolase
Phospho-hexose isomerase kit 38539 11 01 01 28 Phospho Hexose Isomerase
5'-nucleotidase kit 38540 11 01 01 01 5'-Nucleotidase
Amylase isoenzyme kit 38541 11 01 01 08 Amylase Isoenzyme
Angiotensin converting enzyme kit 38542 12 06 02 03 Angiotensin Converting Enzyme (IC) CC =>11.01.01.09
Chymotrypsin kit 38543 11 01 01 12 Chymotrypsin
Glutamate dehydrogenase kit 38544 11 01 01 17 Glutamate Dehydrogenase
Hydroxybutyrate dehydrogenase kit 38545 11 01 01 18 Hydroxybutyrate Dehydrogenase
Leucine aminopeptidase kit 38546 11 01 01 22 Leucine Aminopeptidase
Lysozyme kit 38547 11 01 01 24 Lysozyme
Malate dehydrogenase kit 38548 11 01 01 25 Malate Dehydrogenase
N-acetyl-beta D-glucosaminidase kit 38549 11 01 01 26 N-acetyl-ß,D-Glucosaminidase
Pepsin kit 38550 11 01 01 27 Pepsin
Sorbitol dehydrogenase kit 38551 11 01 01 29 Sorbitol Dehydrogenase
Lactic acid, enzymatic method 38552 11 02 01 18 Lactate
Activated partial thromboplastin time kit 38553 13 02 01 02 Activated Partial Thromboplastin Time
Alanine aminotransferase kit 38556 11 01 01 03 Alanine Amino-Transferase
Sedimentation rate analyser, haematology 38754 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Sample alternating system 38756 28 01 10 01 SP Hardware + accessories + software
Sample processing system 38757 28 01 10 01 SP Hardware + accessories + software
Blood gas monitor, oxygen 38760 21 04 10 01 GE Hardware + dedicated accessories + software
General-purpose, analyser, photometer 38837 21 01 10 01 CH Hardware + dedicated accessories + software

Page 65 of 108
Kit, identification, Neisseria gonorrhoeae 38851 15 01 02 03 Gonococcal Antibody Assays Total

Susceptibility test disk, antimicrobial 38852 24 01 30 01 SI Consumables
Gonococcal antibody test 38854 15 01 02 03 Gonococcal Antibody Assays Total
Enzyme immunoassay, fetal fibronectin 38855 12 01 90 05 Fibronectin
Kit, assay, progesterone receptor 38857 12 03 02 02 Progesterone Receptor Assays
Kit, assay, estrogen receptor 38858 12 03 02 01 Estrogen Receptor Assays
Cyclosporine radioimmunoassay 38859 12 08 06 01 Cyclosporine Total
Test, myelin basic protein 38860 12 10 02 07 Anti-MAG (Myelin Associated Glycoprotein)
Antigen, cancer 549 38862 12 03 01 09 Cancer Antigen 549
Device, susceptibility, topical antimicrobial 38864 24 01 30 01 SI Consumables
Cyclosporine 38865 12 08 06 01 Cyclosporine Total
Lipoprotein, low density, removal 38867 11 02 01 21 Low Density Lipoprotein Cholesterol
Enzyme linked immunosorbent assay, Herpes simplex virus, HSV-1 38870 15 04 03 07 HSV 1 Antibodies - Total
Immunohistochemistry antibody assay, estrogen receptor 38874 12 03 02 01 Estrogen Receptor Assays
Enzyme linked immunosorbent assay, Herpes simplex virus, HSV-2 38875 15 04 03 10 HSV 2 Antibodies - Total
Clostridium tetani kit 38876 15 01 90 09 Tetanus (Clostridium T.)
Parvovirus B19 IgG/IgM kit 38877 15 04 80 09 Parvovirus B 19
System, test, blood glucose, over the counter 38879 11 02 01 13 Glucose
Assay, porphyrin, spectrophotometry, lithium 38883 11 03 01 06 Lithium
Analyzer, gas, nitrogen, partial pressure, blood-phase, non-indwelling 38885 00 00 00 00 Not for IVD use
Analyzer, gas, helium, gaseous-phase 38886 00 00 00 00 Not for IVD use
Analyzer, ion, hydrogen-ion (pH), blood-phase, indwelling 38939 21 04 10 01 GE Hardware + dedicated accessories + software
Analyzer, gas, oxygen, partial pressure, blood-phase, indwelling 38941 21 04 10 01 GE Hardware + dedicated accessories + software
Zimmerman (spectrophotometric), 17-ketosteroid 38949 12 06 05 04 17-Ketogenic Steroids
Acid, nitrous and nitrosonaphthol, 5-hydroxyindole acetic 38950 12 03 90 17 Serotonine
Chromatography separation/Zimmerman 17-ketogenic steroid 38951 12 06 05 04 17-Ketogenic Steroids
Diazonium colorimetry, urobilinogen (urinary, non-quant.) 38952 11 70 02 01 Urine Single Test Strips (incl. tablets)
Acid, uric, uricase (U.V.) 38953 11 02 01 32 Uric Acid
Radioimmunoassay, total triiodothyronine 38954 12 04 01 05 Triiodothyronine
Urease and glutamic dehydrogenase, urea nitrogen 38955 11 02 01 04 Urea/Blood Urea Nitrogen
1-nitroso-2-naphthol (fluorometric), free tyrosine 38956 12 06 90 90 Other Individual and Specified Hormones
Lipase hydrolysis/glycerol kinase enzyme, triglyceride 38957 11 02 01 31 Triglycerides
Radioimmunoassay, testosterones and dihydrotestosterone 38958 12 05 01 10 Testosterone (with Dehydro and Free Testosterone)
TLC chromatographic separation triglyceride 38959 11 02 01 31 Triglycerides
Electrophoretic, protein fractionation 38960 11 02 01 35 Protein Electrophoresis
Biuret (colorimetric), total protein 38961 11 02 01 30 Total Protein
Ammonium molybdate and ammonium vanadate, phospholipid 38962 11 02 01 24 Phospholipids
Dye-indicator, pH (urinary, non-quant.) 38963 11 70 02 01 Urine Single Test Strips (incl. tablets)
Phosphomolybdate (colorimetric), inorganic phosphorus 38964 11 03 01 08 Phosphate inorganic / Phosphorus
Radioimmunoassay, luteinizing hormone 38965 12 05 01 05 Luteinising Hormone

Page 66 of 108
Chromogenesis, phenylketone (urinary, non-quant.) 38966 11 02 01 36 Phenylketonuria

Olive oil emulsion (turbidimetric), lipase 38967 11 01 01 23 Lipase
Chromatographic separation, lactate dehydrogenase isoenzyme 38968 11 01 01 21 Lactate Dehydrogenase Isoenzymes
Oil emulsion/thymolphthalein (titrimetric), lipase 38969 11 01 01 23 Lipase
Bathophenanthroline, colorimetry, iron (non-heme) 38970 11 02 01 16 Iron (CC) IC =>12.07.01.04
Radioimmunoassay, estrone 38971 12 05 02 04 Estrone
Electrophoretic, globulin 38972 11 02 01 35 Protein Electrophoresis
Radioimmunoassay, follicle-stimulating hormone 38973 12 05 01 04 Follicle Stimulating Hormone
NAD reduction/NADH oxidation, CPK or isoenzyme 38974 11 01 01 13 Creatine Kinase - Total
Radioimmunoassay, cyclic GMP 38975 12 06 90 19 Cyclic Guanosine Monophosphate
Electrode, ion-specific, chloride 38976 11 04 01 03 Chloride - Electrodes
Titrimetric permanganate and bromophenol blue, calcium 38977 11 03 01 03 Calcium
Acid, phosphoric-tungstic (spectrophotometric), chloride 38978 11 03 01 04 Chloride
Enzymatic esterase-oxidase, cholesterol 38979 11 02 01 05 Cholesterol
Lipase-esterase, enzymatic, photometric, lipase 38980 11 01 01 23 Lipase
Mercuric nitrate and diphenyl carbazone (titrimetric), chloride 38981 11 03 01 04 Chloride
Analyzer, ion, hydrogen-ion (pH), blood phase, non-indwelling 38982 21 04 10 01 GE Hardware + dedicated accessories + software
Radioimmunoassay, total estrogen in pregnancy 38983 12 05 02 04 Estrone
Coulometric method, carbon-dioxide 38984 11 03 01 02 Bicarbonate
Titrimetric with EDTA and indicator, calcium 38985 11 03 01 03 Calcium
DI (O-hydroxyphenylimine) ethane, calcium 38986 11 03 01 03 Calcium
Radioimmunoassay, angiotensin I and renin 38987 12 06 02 02 Angiotensin I / II
Alizarin sulfonate, calcium 38988 11 03 01 03 Calcium
Electrophoretic separation, alkaline phosphatase isoenzyme 38989 11 01 01 06 Alkaline Phosphatase Isoenzymes(CC) IC => 12.06.03.01
Thymolphthalein monophosphate, alkaline phosphatase or isoenzyme 38990 11 01 01 05 Alkaline Phosphatase - Total
Bromcresol green dye-binding, albumin 38991 11 02 01 01 Albumin (CC) IC =>12.01.03.01
Radioimmunoassay, androsterone 38992 12 05 01 11 Androsterone
Fructose-1, 6-diphosphate and NADH (U.V.), aldolase 38993 11 01 01 04 Aldolase
Nitrophenylphosphate, alkaline phosphatase or isoenzyme 38994 11 01 01 05 Alkaline Phosphatase - Total
Thymol blue monophosphate, alkaline phosphatase or isoenzyme 38995 11 01 01 05 Alkaline Phosphatase - Total
Disodium phenylphosphate, alkaline phosphatase or isoenzyme 38996 11 01 01 05 Alkaline Phosphatase - Total
Phenolphthalein phosphate, alkaline phosphatase or isoenzyme 38997 11 01 01 05 Alkaline Phosphatase - Total
Beta glycerophosphate, alkaline phosphatase or isoenzyme 38998 11 01 01 05 Alkaline Phosphatase - Total
Radioimmunoassay, aldosterone 38999 12 06 02 01 Aldosterone
Alpha-naphthyl phosphate, alkaline phosphatase or isoenzyme 39000 11 01 01 05 Alkaline Phosphatase - Total
Acid phosphatase, disodium phenylphosphate 39001 11 01 01 02 Acid Phosphatase (CC) IC => 12.03.01.37
Vanillin pyruvate, ALT/SPGT 39002 11 01 01 03 Alanine Amino-Transferase
Acid phosphatase, thymolphthalein monophosphate 39003 11 01 01 02 Acid Phosphatase (CC) IC => 12.03.01.37
Phenylphosphate, alkaline phosphatase or isoenzyme 39004 11 01 01 05 Alkaline Phosphatase - Total
Radioimmunoassay, ACTH 39005 12 06 04 01 Adrenocortiotropic Hormone

Page 67 of 108
Inter-alpha trypsin inhibitor, antigen, antiserum, control 39006 12 01 90 06 Trypsin-a1-Antitrypsin (Elastase)

Bence-jones protein, antigen, antiserum, control 39007 12 01 01 20 Kappa and Lambda chain
Hemopexin, rhodamine, antigen, antiserum, control 39008 12 01 03 04 Haemopexin
Hemopexin, FITC, antigen, antiserum, control 39009 12 01 03 04 Haemopexin
Complement C3, antigen, antiserum, control 39010 12 01 02 03 Complement Component C3/C3c
Hemopexin, antigen, antiserum, control 39011 12 01 03 04 Haemopexin
Complement C1s, antigen, antiserum, control 39012 12 01 02 01 Complement Component C1q
Complement C9, antigen, antiserum, control 39013 12 01 02 07 Complement Component C5-9
Complement C1r, antigen, antiserum, control 39015 12 01 02 01 Complement Component C1q
Complement C1q, antigen, antiserum, control 39016 12 01 02 01 Complement Component C1q
Hemoglobin, chain specific, antigen, antiserum, control 39017 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
IgM (mu chain specific), antigen, antiserum, control 39018 12 01 01 07 Immunoglobulin M
Fibrinogen and fibrin split product, antigen, antiserum, control 39019 13 02 05 02 Fibrinogen Degradation Products
IgG (Fd fragment specific), antigen, antiserum, control 39020 12 01 01 06 Immunoglobulin G subclass reagents
Fibrinogen and split product, rhodamine, antigen, antiserum, control 39021 13 02 05 02 Fibrinogen Degradation Products
IgG (Fc fragment specific), antigen, antiserum, control 39022 12 01 01 06 Immunoglobulin G subclass reagents
Fibrinogen and split product, peroxidase, antigen, antiserum, control 39023 13 02 05 02 Fibrinogen Degradation Products
Alpha-2-AP-glycoprotein, antigen, antiserum, control 39024 12 01 90 90 Other Other Plasma Proteins
Fibrinogen and split product, FITC, antigen, antiserum, control 39025 13 02 05 02 Fibrinogen Degradation Products
Fibrinogen and split product, antigen, antiserum, control 39027 13 02 05 02 Fibrinogen Degradation Products
Complement C1 inhibitor (inactivator), antigen, antiserum, control 39028 12 01 02 02 Complement Component C1 inactivator
Alpha 2, 2N-glycoprotein, antigen, antiserum, control 39029 12 01 90 90 Other Other Plasma Proteins
Antismooth muscle antibody, indirect immunofluorescent, antigen, 39030 12 10 01 11 Sm
Complement C4, antigen, antiserum, control 39031 12 01 02 05 Complement Component C4
Antiparietal antibody, indirect immunofluorescent, antigen, control 39032 12 10 90 11 Parietal Cell Antibodies
Antimitochondrial antibody, indirect immunofluorescent, antigen, 39033 12 10 90 02 Anti-Mitochondrial Antibodies
Factor XIII A, S, antigen, antiserum, control 39034 13 02 02 14 Coagulation factor XIII
Beta-globulin, antigen, antiserum, control 39035 12 01 90 90 Other Other Plasma Proteins
C-reactive protein, antigen, antiserum, and control 39036 12 11 01 09 C-Reactive Protein IC=> 12 70 11 01
Alpha-globulin, antigen, antiserum, control 39037 12 01 90 90 Other Other Plasma Proteins
Carbonic anhydrase B, antigen, antiserum, control 39038 12 01 90 90 Other Other Plasma Proteins
Beta-2-glycoprotein III, antigen, antiserum, control 39039 12 10 90 04 Anti-ß2-Glycoprotein I Antibodies
Beta-2-glycoprotein I, antigen, antiserum, control 39040 12 10 90 04 Anti-ß2-Glycoprotein I Antibodies
Alpha-2-macroglobulin, rhodamine, antigen, antiserum, control 39041 12 01 90 03 a2-Macroglobulin
Plasminogen, antigen, antiserum, control 39042 13 02 05 05 Plasminogen
Alpha-2-macroglobulin, FITC, antigen, antiserum, control 39043 12 01 90 03 a2-Macroglobulin
Alpha-2-macroglobulin, antigen, antiserum, control 39044 12 01 90 03 a2-Macroglobulin
Inter-alpha trypsin inhibitor, FITC, antigen, antiserum, control 39045 12 01 90 06 Trypsin-a1-Antitrypsin (Elastase)

Page 68 of 108
Alpha-2-HS-glycoprotein, antigen, antiserum, control 39046 12 01 90 90 Other Other Plasma Proteins

Alpha-2-glycoprotein, antigen, antiserum, control 39047 12 01 90 90 Other Other Plasma Proteins
Alpha-1-T-glycoprotein, antigen, antiserum, control 39048 12 01 90 01 a1-Acid Glycoprotein ( Orosomucoid )
Alpha-1-lipoprotein, antigen, antiserum, control 39049 12 01 04 21 Lipoprotein ( a )
Alpha-1-B-glycoprotein, antigen, antiserum, control 39050 12 01 90 01 a1-Acid Glycoprotein ( Orosomucoid )
Alpha-1-antitrypsin, rhodamine, antigen, antiserum, control 39051 12 01 90 02 a1-Antitrypsin ( Protease inhibitor )
Lipoprotein, low-density, antigen, antiserum, control 39052 11 02 01 21 Low Density Lipoprotein Cholesterol
Alpha-1-antichymotrypsin, antigen, antiserum, control 39053 12 01 90 90 Other Other Plasma Proteins
Total spinal-fluid, antigen, antiserum, control 39054 11 50 90 03 CSF controls
IgG (Fab fragment specific), antigen, antiserum, control 39055 12 01 01 06 Immunoglobulin G subclass reagents
IgG (gamma chain specific), antigen, antiserum, control 39056 12 01 01 06 Immunoglobulin G subclass reagents
Seminal fluid, antigen, antiserum, control 39057 12 01 90 90 Other Other Plasma Proteins
Breast milk, rhodamine, antigen, antiserum, control 39058 12 05 02 90 Other Pregnancy Testing Hormones
System, test, human chorionic gonadotropin 39060 13 02 05 05 Plasminogen
Antinuclear antibody, indirect immunofluorescent, antigen, control 39061 12 10 01 01 ANA Screening
Alcohol dehydrogenase, specific reagent for ethanol enzyme method 39062 12 09 02 07 Ethanol (Alcohol)
Bacillus subtlis microbiology assay, tobramycin 39063 14 02 03 01 Serotyping (E.coli, Salmonella, Shigella, etc.)
Cholinesterase test paper 39064 11 70 01 90 Other Blood Test Strips
Lead, delta amino levulinic acid 39065 11 02 01 09 Delta-Aminolaevulinic acid
Enzyme immunoassay, cocaine and cocaine metabolite 39066 12 09 01 06 Cocaine + Cocaine Metabolites
Radioimmunoassay, morphine (3-H), goat antibody ammonium sulfate 39067 12 09 01 12 Morphines
Hemagglutination inhibition, methadone 39068 12 09 01 10 Methadone
Radioimmunoassay, gentamicin (125-I), second antibody sep. 39069 12 08 03 04 Gentamicin
Thin layer chromatography, metamphetamine 39070 12 09 01 02 Amphetamine/Methamphetamine Specific (+Ecstasy)
Fluorometry, morphine 39071 12 09 01 12 Morphines
Test reagent for phenothiazine 39072 12 08 02 90 Other Central Nervous System TDM
Test reagent for chloral hydrate 39073 12 08 02 90 Other Central Nervous System TDM
Antiserum, digoxin 39074 12 08 01 01 Digoxin
Bacillus subtlis, microbiological assay, gentamicin 39075 14 02 03 01 Serotyping (E.coli, Salmonella, Shigella, etc.)
Test reagent for sulphanimide derivative 39076 12 08 03 90 Other Antibiotics TDM
Test reagent for methyl alcohol 39077 12 09 02 90 Other Toxicology
Radioimmunoassay, LSD (125-I) 39078 12 09 01 09 Lysergic acid diethylamide
Reagent, test, bromide 39079 12 08 02 90 Other Central Nervous System TDM
Acetylcholine chloride, specific reagent for pseudo cholinesterase 39080 11 01 01 11 Cholinesterase
Hemagglutination, cocaine metabolite (benzoylecgnonine) 39081 12 09 01 06 Cocaine + Cocaine Metabolites
Hemagglutination inhibition, morphine 39082 12 09 01 12 Morphines
Gas chromatograph, alcohol (dedicated instrument) 39083 21 01 10 01 CH Hardware + dedicated accessories + software
Hemagglutination, opiate 39084 12 09 01 13 Opiates
Hemagglutination inhibition, barbiturate 39085 12 09 01 03 Barbiturates
Potassium dichromate specific reagent for alcohol 39086 12 09 02 07 Ethanol (Alcohol)

Page 69 of 108
Test reagent for ethyl alcohol 39087 12 09 02 07 Ethanol (Alcohol)

NAD-NADH, specific reagent for alcohol enzyme method 39088 12 09 02 07 Ethanol (Alcohol)
Solution, m-nitrophenol, specific reagent for cholinesterase 39089 11 01 01 11 Cholinesterase
Radioimmunoassay, morphine-barbiturate (125-I), goat antibody 39090 12 09 01 12 Morphines
Strip, paper, salicylate 39091 12 09 02 13 Salicylate
Atomic absorption, antimony 39092 11 03 01 90 Other Electrolytes
Radioimmunoassay, digoxin (125-I), goat antibody, 2nd antibody sep. 39093 12 08 01 01 Digoxin
Calibrator, ethyl alcohol 39094 12 50 01 01 TDM/Drug Standards / Calibrators
Hemagglutination inhibition, gentamicin 39095 12 08 03 04 Gentamicin
Atomic absorption, arsenic 39096 11 03 01 90 Other Electrolytes
Radioimmunoassay, digoxin (125-I), goat antibody, anion exchange, 39097 12 08 01 01 Digoxin
Radioimmunoassay, digitoxin (3-H) 39098 12 08 01 02 Digitoxin
Radioimmunoassay, morphine (125-I), goat antibody ammonium 39099 12 09 01 12 Morphines
Lead, atomic absorption 39100 12 09 02 90 Other Toxicology
Radioimmunoassay, digoxin (125-I), rabbit antibody, solid phase sep. 39101 12 08 01 01 Digoxin
Mass spectrometer, clinical use 39102 21 04 10 01 GE Hardware + dedicated accessories + software
Radioimmunoassay, digoxin (3-H), bovine antibody, charcoal sep. 39103 12 08 01 01 Digoxin
Radioimmunoassay, digitoxin (3-H), rabbit antibody, coated tube 39104 12 08 01 02 Digitoxin
Fluorometer, lead (dedicated instruments) 39105 21 02 10 01 IC Hardware + dedicated accessories + software
Radioimmunoassay, digoxin (3-H), goat antibody, 2nd antibody sep. 39106 12 08 01 01 Digoxin
Radioimmunoassay, digoxin (3-H), rabbit antibody, charcoal sep. 39107 12 08 01 01 Digoxin
Radioimmunoassay, digitoxin (125-I), rabbit antibody, coated tube sep. 39108 12 08 01 02 Digitoxin
Mercury, atomic absorption 39109 12 09 02 90 Other Toxicology
Radioimmunoassay, digoxin (125-I), bovine antibody, charcoal sep. 39110 12 08 01 01 Digoxin
Radioimmunoassay, amphetamine (125-I), goat antibody, ammonium 39111 12 09 01 01 Amphetamines Group
Radioimmunoassay, digitoxin (125-I), bovine antibody, charcoal sep. 39112 12 08 01 02 Digitoxin
Fibrinogen determination standards and control 39411 13 02 50 02 Control Plasmas
Standards and control, hemoglobin, normal and abnormal 39412 13 01 20 04 Haemoglobin Control
Fibrinogen standard 39413 13 02 50 02 Control Plasmas
Iron stain 39414 13 01 03 90 Other Haematology stains
Fluid, diluting, white-cell 39415 13 01 01 01 CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)
Control, white-cell 39416 13 01 20 90 Other Haematology Controls
Reagent, thromboplastin and control 39417 13 02 01 02 Activated Partial Thromboplastin Time
Hemoglobin, alkali resistant 39418 13 01 02 01 Haemoglobin determinations (Total Hb)
Hemocytometer 39419 23 05 10 01 HC Hardware + dedicated accessories + software
Stain, fetal hemoglobin 39420 13 01 03 01 Histo/Cyto stains
Assay, carboxyhemoglobin 39421 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
Hematocrit, tube, rack, sealer, holder 39422 23 09 30 01 Other_HHC Consumables
Hemoglobin 39423 13 01 02 01 Haemoglobin determinations (Total Hb)
Reagent & control, partial thromboplastin time 39424 13 02 01 02 Activated Partial Thromboplastin Time

Page 70 of 108
Assay, sulfhemoglobin 39425 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)

Stain, reticulocyte 39426 13 01 03 01 Histo/Cyto stains
Stain, Heinz body 39427 13 01 03 01 Histo/Cyto stains
Fluid, diluting, red-cell 39428 13 01 01 01 CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)
Control, red-cell 39429 13 01 20 03 Control Blood Multilevel
Cyanomethemoglobin reagent and standard solution 39430 13 01 02 01 Haemoglobin determinations (Total Hb)
Abnormal hemoglobin quantitation 39431 13 01 02 01 Haemoglobin determinations (Total Hb)
Instrument, hematocrit, automated 39432 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Centrifuge, hematocrit 39433 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Cyanomethemoglobin 39434 13 01 02 01 Haemoglobin determinations (Total Hb)
System, hemoglobin, automated 39435 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Control, hematocrit 39436 13 01 20 90 Other Haematology Controls
Antisera, fluorescent, Sporothrix schenekii 39438 15 06 01 90 Other Mycology Immunoassays
Antisera, latex agglutination, Cryptococcus neoformans 39439 15 06 01 90 Other Mycology Immunoassays
Antisera, fluorescent, Cryptococcus neoformans 39440 15 06 01 90 Other Mycology Immunoassays
Antiserum, positive control, Coccidioides immitis 39441 15 50 01 06 Mycology Controls - Inf.Imm.
Antigen, CF and/or ID, Coccidioides immitis 39442 15 06 01 90 Other Mycology Immunoassays
Antiserum, positive control, Histoplasma capsulatum 39443 15 50 01 06 Mycology Controls - Inf.Imm.
Antisera, fluorescent, Histoplasma capsulatum 39444 15 06 01 90 Other Mycology Immunoassays
Antigen, latex agglutination, Entamoeba histolytica & rel. spp. 39445 15 05 10 01 Entamoeba histolytica
Antisera, control for nontreponemal test 39446 15 50 01 01 Bacteriology Controls - Inf.Imm.
Antigen, nontreponemal, all 39447 15 01 90 90 Other Other Bacteriology Immunoassays
Sera, reactive and non-specific control, FTA-ABS test 39448 15 01 03 03 Syphilis Antibody Assays Total
Antigen, all types, Escherichia coli 39450 15 01 15 01 E. Coli Direct Antigen Detection
Antisera, all types, Shigella spp. 39452 15 01 90 14 Shigella
Antigen, febrile, slide and tube, all groups, Salmonella spp. 39453 15 01 10 01 Salmonella Antigen Detection
Antigen, CF (including CF control), coxsackievirus A 1-24, B 1-6 39454 15 04 80 90 Other Viral Antigen/Antibody Detection
Antigen, fluorescent antibody test, Schistosoma mansoni 39455 15 05 10 06 Schistosoma
Antisera, neutralization, echovirus 1-34 39456 15 04 80 90 Other Viral Antigen/Antibody Detection
Antisera, CF, echovirus 1-34 39457 15 04 80 90 Other Viral Antigen/Antibody Detection
Antigen, CF (including CF control), echovirus 1-34 39458 15 04 80 90 Other Viral Antigen/Antibody Detection
Antisera, fluorescent, coxsackievirus A 1-24, B 1-6 39459 15 04 80 90 Other Viral Antigen/Antibody Detection
Antisera, neutralization, coxsackievirus A 1-24, B 1-6 39460 15 04 80 90 Other Viral Antigen/Antibody Detection
Antisera, CF, coxsackievirus A 1-24, b 1-6 39461 15 04 80 90 Other Viral Antigen/Antibody Detection
Antisera, neutralization, influenza virus A, B, C 39463 15 04 80 04 Influenza & Para Influenza
Antisera, HAI, influenza virus A, B, C 39464 15 04 80 04 Influenza & Para Influenza
Antigen, HA (including HA control), influenza virus A, B, C 39465 15 04 80 04 Influenza & Para Influenza
Antisera, CF, influenza virus A, B, C 39466 15 04 80 04 Influenza & Para Influenza
Antigen, CF (including CF control), influenza virus A, B, C 39467 15 04 80 04 Influenza & Para Influenza
Antisera, fluorescent, adenovirus 1-33 39468 15 04 80 01 Adenovirus

Page 71 of 108
Antisera, neutralization, adenovirus 1-33 39469 15 04 80 01 Adenovirus

Antisera, CF, adenovirus 1-33 39470 15 04 80 01 Adenovirus
Antigen, HA (including HA control), adenovirus 1-33 39471 15 04 80 01 Adenovirus
Antisera, HAI, adenovirus 1-33 39472 15 04 80 01 Adenovirus
Antigen, CF (including CF control), adenovirus 1-33 39473 15 04 80 01 Adenovirus
Antisera, fluorescent, poliovirus 1-3 39474 15 04 80 90 Other Viral Antigen/Antibody Detection
Antisera, neutralization, poliovirus 1-3 39475 15 04 80 90 Other Viral Antigen/Antibody Detection
Antisera, CF, poliovirus 1-3 39476 15 04 80 90 Other Viral Antigen/Antibody Detection
Antigen, CF (including CF control), poliovirus 1-3 39477 15 04 80 90 Other Viral Antigen/Antibody Detection
Antisera, neutralization, rubella 39478 15 04 01 04 Rubella Virus Antibodies - Total
Antisera, HAI (including HAI control), rubella 39479 15 04 01 04 Rubella Virus Antibodies - Total
Antisera, CF, rubella 39480 15 04 01 04 Rubella Virus Antibodies - Total
Antisera, fluorescent, all globulins, Salmonella spp. 39481 15 01 10 03 Salmonella Antibody Assays
Antisera, C. acnes (553, 605) 39482 15 01 90 90 Other Other Bacteriology Immunoassays
Antisera, agglutinating, B. parapertussis 39483 15 01 90 07 Bordetella pertussis / parapertussis
Antisera, agglutinating, B. pertussis, all 39484 15 01 90 07 Bordetella pertussis / parapertussis
Antisera, fluorescent, B. pertussis 39485 15 01 90 07 Bordetella pertussis / parapertussis
Antisera, positive control, Echinococcus spp. 39486 15 06 01 90 Other Mycology Immunoassays
Antigen, agglutinating, Echinococcus spp. 39487 15 05 10 04 Echinococcus
Antiserum, bentonite flocculation, Trichinella spiralis 39488 15 05 10 90 Other Parasitology
Antiserum, rickettsialpox 39489 15 01 90 05 Rickettsia
Antigen, CF, psittacosis (Chlamydia group) 39490 15 01 01 90 Other Chlamydia Reagents
Antisera, neutralizion, reovirus 1-3 39491 15 04 80 90 Other Viral Antigen/Antibody Detection
Antisera, HAI, reovirus 1-3 39492 15 04 80 90 Other Viral Antigen/Antibody Detection
Antisera, CF, reovirus 1-3 39493 15 04 80 90 Other Viral Antigen/Antibody Detection
Antigen, HA (including HA control), reovirus 1-3 39494 15 04 80 90 Other Viral Antigen/Antibody Detection
Antigen, CF (including CF control), reovirus 1-3 39495 15 04 80 90 Other Viral Antigen/Antibody Detection
Antisera, CF, equine encephalitis virus, EEE, WEE 39496 15 04 80 90 Other Viral Antigen/Antibody Detection
Antigen, CF (including CF control), equine encephalitis virus, EEE, 39497 15 04 80 90 Other Viral Antigen/Antibody Detection
Antisera, neutralization, all types, rhinovirus 39498 15 04 80 90 Other Viral Antigen/Antibody Detection
Antiserum, neutralization, respiratory syncytial virus 39499 15 04 80 05 Respiratory Syncytial Virus (RSV)
Antigen, CF (including CF controls), respiratory syncytial virus 39500 15 04 80 05 Respiratory Syncytial Virus (RSV)
Antigen, CF (including CF control), cytomegalovirus 39501 15 04 02 01 CMV Antigen
Antisera, fluorescent, herpesvirus hominis 1,2 39502 15 04 03 04 HSV Antibodies - Total
Antisera, neutralization, Herpesvirus hominis 39503 15 04 03 04 HSV Antibodies - Total
Antigen, CF (including CF control), herpesvirus hominis 1,2 39504 15 04 03 01 HSV Antigen
Antisera, CF, herpesvirus hominis 1, 2 39505 15 04 03 04 HSV Antibodies - Total
Antisera, neutralization, parainfluenza virus 1-4 39506 15 04 80 04 Influenza & Para Influenza
Antisera, HAI, parainfluenza virus 1-4 39507 15 04 80 04 Influenza & Para Influenza
Antigen, HA (including HA control), parainfluenza virus 1-4 39508 15 04 80 04 Influenza & Para Influenza

Page 72 of 108
Antigen, CF (including CF control), parainfluenza virus 1-4 39509 15 04 80 04 Influenza & Para Influenza
Antisera, CF, parainfluenza virus 1-4 39510 15 04 80 04 Influenza & Para Influenza
Antigen, CF, (including CF control), varicella-zoster 39511 15 04 80 10 Varicella Zoster
Antiserum, CF, varicella-zoster 39512 15 04 80 10 Varicella Zoster
Antigen, HA (including HA control), mumps virus 39513 15 04 80 08 Mumps / Parotitis
Antiserum, neutralization, mumps virus 39514 15 04 80 08 Mumps / Parotitis
Antigen, CF (including CF control), mumps virus 39515 15 04 80 08 Mumps / Parotitis
Antiserum, neutralization, rubeola 39517 15 04 01 04 Rubella Virus Antibodies - Total
Antisera, fluorescent, echovirus 1-34 39519 15 04 80 90 Other Viral Antigen/Antibody Detection
Antigen, all groups, Salmonella spp. 39520 15 01 10 01 Salmonella Antigen Detection
Antisera, all groups, Salmonella spp. 39521 15 01 10 03 Salmonella Antibody Assays
Antisera, fluorescent, all types, Hemophilus spp. 39522 15 01 90 90 Other Other Bacteriology Immunoassays
Antisera, all types, H. influenza 39523 15 04 80 04 Influenza & Para Influenza
Antisera, all fluorescent, Leptospira spp. 39524 15 01 90 04 Leptospira
Antisera, all Leptospira spp. 39525 15 01 90 04 Leptospira
Antigen, all, Leptospira spp. 39526 15 01 90 04 Leptospira
Antisera, fluorescent, all, Mycoplasma spp. 39527 15 01 08 03 Mycoplasma Antibody Assays
Antisera, all Mycoplasma spp. 39528 15 01 08 03 Mycoplasma Antibody Assays
Antigen, CF, all, Mycoplasma spp. 39529 15 01 08 01 Mycoplasma Antigen Detection
Antisera, fluorescent, all types, Listeria monocytogenes 39530 15 01 13 13 Listeria Monocytogenes Antibody assays
Antisera, all types, Listeria monocytogenes 39531 15 01 13 13 Listeria Monocytogenes Antibody assays
Antigen, slide and tube, all types, Listeria monocytogenes 39532 15 01 13 11 Listeria Monocytogenes direct Antigen detection
Antigen, slide and tube, Francisella tularensis 39533 15 01 90 90 Other Other Bacteriology Immunoassays
Antisera, fluorescent, Brucella spp. 39534 15 01 90 01 Brucella
Antiserum, positive and negative febrile antigen control serum 39535 15 50 01 01 Bacteriology Controls - Inf.Imm.
Antigens (febrile), agglutination, Brucella spp. 39536 15 01 90 01 Brucella
Antiserum, Vibrio cholerae, all varieties 39537 15 01 90 90 Other Other Bacteriology Immunoassays
Antisera, fluorescent, Pseudomonas pseudomallei 39538 15 01 90 13 Pseudomonas
Antisera, fluorescent, Pseudomonas aeruginosa 39539 15 01 09 03 Pseudomonas Aeruginosa Antibody IgG
Antiserum, Flavobacterium meningosepticum, all groups 39540 15 01 90 90 Other Other Bacteriology Immunoassays
Antisera, Acinetobacter calcoaceticus, all varieties 39541 15 01 90 90 Other Other Bacteriology Immunoassays
Antisera, fluorescent, all globulins, Proteus spp. 39542 15 01 90 12 Proteus
Antigen, febrile (Weil-Felix), all groups 39543 15 01 90 12 Proteus
Antisera, all, Serratia marcesans 39544 15 01 90 90 Other Other Bacteriology Immunoassays
Antisera, fluorescent, all types, Klebsiella spp. 39545 15 01 90 90 Other Other Bacteriology Immunoassays
Antisera, all types, Klebsiella spp. 39546 15 01 90 90 Other Other Bacteriology Immunoassays
Antisera, fluorescent, all globulins, Shigella spp. 39547 15 01 90 14 Shigella
Antisera, Arizona spp., all 39548 15 01 90 90 Other Other Bacteriology Immunoassays
Antisera, Bethesda - ballerup polyvalent, Citrobacter spp. 39549 15 01 90 90 Other Other Bacteriology Immunoassays
Antisera, fluorescent, all groups, N. meningitidis 39550 15 01 90 11 Neisseria meningitidis

Page 73 of 108
Antisera, all groups, N. meningitidis 39551 15 01 90 11 Neisseria meningitidis

Antistreptolysin - titer/streptolysin O reagent 39552 12 11 01 05 Anti-Streptolysin/Anti-Streptolysin O (qualitative)
Antideoxyribonuclease, Streptococcus spp. 39553 15 01 11 40 Streptococci Detection by NA Reagents
Indirect fluorescent antibody test, Entamoeba histolytica & rel sp 39558 15 05 10 01 Entamoeba histolytica
Eosin Y 39725 13 01 03 01 Histo/Cyto stains
Fast green 39726 13 01 03 01 Histo/Cyto stains
Fast red salt B 39727 13 01 03 01 Histo/Cyto stains
Hematoxylin Harris's 39728 13 01 03 01 Histo/Cyto stains
Hematoxylin Mayer's 39729 13 01 03 01 Histo/Cyto stains
Hematoxylin Weigert's 39730 13 01 03 01 Histo/Cyto stains
Stain, trichrome, Mallory's 39731 13 01 03 01 Histo/Cyto stains
Methenamine silver 39732 13 01 03 01 Histo/Cyto stains
Acid, osmic 39733 13 01 03 01 Histo/Cyto stains
Stain, Papanicolau 39734 13 01 03 01 Histo/Cyto stains
Stain, Ponceau 39735 13 01 03 01 Histo/Cyto stains
Reagent, Schiff 39736 13 01 03 01 Histo/Cyto stains
Van Gieson's stain 39737 13 01 03 01 Histo/Cyto stains
Hematoxylin, iron, Weigert's 39738 13 01 03 01 Histo/Cyto stains
Wright's stain 39739 13 01 03 01 Histo/Cyto stains
Solution, Lugol's 39740 13 01 03 01 Histo/Cyto stains
Collodion 39741 13 01 03 01 Histo/Cyto stains
Colchicine 39742 13 01 03 01 Histo/Cyto stains
Eosin B 39744 13 01 03 01 Histo/Cyto stains
Darrow red 39745 13 01 03 01 Histo/Cyto stains
Crystal violet for histology 39746 13 01 03 01 Histo/Cyto stains
Cresyl violet acetate 39747 13 01 03 01 Histo/Cyto stains
Congo red 39748 13 01 03 01 Histo/Cyto stains
Carbol night blue 39749 13 01 03 01 Histo/Cyto stains
Carbol fuchsin 39750 13 01 03 01 Histo/Cyto stains
Brilliant yellow 39751 13 01 03 01 Histo/Cyto stains
Biebrich scarlet 39752 13 01 03 01 Histo/Cyto stains
Azure A 39753 13 01 03 01 Histo/Cyto stains
Azocarmine B 39754 13 01 03 01 Histo/Cyto stains
Azocarmine G 39755 13 01 03 01 Histo/Cyto stains
Aniline 39756 13 01 03 01 Histo/Cyto stains
Acid, aniline, fuchsin 39757 13 01 03 01 Histo/Cyto stains
Ammoniacal silver hydroxide silver nitrate 39758 13 01 03 01 Histo/Cyto stains
Alcian blue 39759 13 01 03 01 Histo/Cyto stains
Aldehyde fuchsin 39760 13 01 03 01 Histo/Cyto stains
Acridine orange 39761 13 01 03 01 Histo/Cyto stains

Page 74 of 108
Alizarin red 39762 13 01 03 01 Histo/Cyto stains

Acid, hematein 39763 13 01 03 01 Histo/Cyto stains
Acid, fuchsin 39764 13 01 03 01 Histo/Cyto stains
Solution, Zenker's 39766 13 01 03 01 Histo/Cyto stains
Solution, Orth's 39767 13 01 03 01 Histo/Cyto stains
Solution, Helly 39768 13 01 03 01 Histo/Cyto stains
Formaldehyde (formalin, formol) 39769 13 01 03 01 Histo/Cyto stains
Solution, Carnoy's 39770 13 01 03 01 Histo/Cyto stains
Fluid, Bouin's 39771 13 01 03 01 Histo/Cyto stains
Solubility, hemoglobin, abnormal 39818 13 01 02 01 Haemoglobin determinations (Total Hb)
System, analysis, electrophoretic hemoglobin 39819 13 01 02 01 Haemoglobin determinations (Total Hb)
Cell enzymes (erythrocytic and leukocytic) 39820 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Glucose-6-phosphate dehydrogenase (erythrocytic), screening 39821 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Glucose-6-phosphate dehydrogenase (erythrocytic), spot 39822 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Glucose-6-phosphate dehydrogenase (erythrocytic), micromethod 39823 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Glucose-6-phosphate dehydrogenase (erythrocytic), catalase inhibition 39824 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Glucose-6-phosphate dehydrogenase (erythrocytic), methemoglobin 39825 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Glucose-6-phosphate dehydrogenase (erythrocytic), U.V. kinetic 39826 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Glucose-6-phosphate dehydrogenase (erythrocytic), quantitative 39827 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Glucose-6-phosphate dehydrogenase (erythrocytic), electrophoresis 39828 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Activated whole blood clotting time 39829 13 02 01 04 Activated Clotting Time
Alkaline phosphatase 39830 11 01 01 05 Alkaline Phosphatase - Total
Control, hemoglobin, abnormal 39831 13 01 20 04 Haemoglobin Control
Analyzer, gas, neon, gaseous-phase 39841 00 00 00 00 Not for IVD use
Analyzer, gas, argon, gaseous-phase 39842 00 00 00 00 Not for IVD use
Acid phosphatase (prostatic), tartrate inhibited 39851 12 03 01 37 Prostatic Acid Phosphatase (IC) CC =>11.01.01.02
Atomic absorption, calcium 39852 11 03 01 03 Calcium
Tryptophan measurement (colorimetric), globulin 39853 11 02 01 01 Albumin (CC) IC =>12.01.03.01
Differential rate kinetic method, lactate dehydrogenase isoenzyme 39854 11 01 01 19 Lactate Dehydrogenase L ( LDH - L --> P )
L-leucine-4-nitroanilide (colorimetric), leucine arylamidase 39855 11 01 01 22 Leucine Aminopeptidase
Atomic absorption, magnesium 39856 11 03 01 07 Magnesium
Ferric chloride, phenylketones (urinary, non-quant.) 39857 11 02 01 36 Phenylketonuria
Lowry (colorimetric), total protein 39858 11 02 01 30 Total Protein
Acid, uric, uricase (gasometric) 39859 11 02 01 32 Uric Acid
Acid, uric, uricase (colorimetric) 39860 11 02 01 32 Uric Acid
Acid, uric, uricase (oxygen rate) 39861 11 02 01 32 Uric Acid
Colorimetric method, lecithin/sphingomyelin ratio 39862 11 02 01 19 Lecithin
Chromatographic separation, lecithin/sphingomyelin ratio 39863 11 02 01 90 Other Substrates
Radioimmunoassay, human chorionic gonadotropin 39864 12 05 02 05 Human Chorionic Gonadotropin Total
Agglutination method, human chorionic gonadotropin 39865 12 05 02 05 Human Chorionic Gonadotropin Total

Page 75 of 108
Colorimetric method, lipoprotein 39866 11 02 01 20 Lipoprotein, Chemical determination/detection

Differential rate kinetic method, CPK or isoenzyme 39867 11 01 01 13 Creatine Kinase - Total
U.V. method, CPK isoenzyme 39868 11 01 01 13 Creatine Kinase - Total
Fluorometric method, CPK or isoenzyme 39869 11 01 01 13 Creatine Kinase - Total
Colorimetric method, CPK or isoenzyme 39870 11 01 01 13 Creatine Kinase - Total
U.V. method, galactose 39871 11 02 01 12 Galactose
Electrode, ion-specific method, ammonia 39872 11 04 01 01 Ammonia - Electrodes
Flame photometer, lithium 39873 11 03 01 06 Lithium
Atomic absorption, lithium 39874 11 03 01 06 Lithium
Dry ash method, protein-bound iodine 39875 12 04 01 90 Other thyroid hormones
Method, enzymatic, glucose (urinary, non-quantitative) 39876 11 70 02 01 Urine Single Test Strips (incl. tablets)
Method, metallic reduction, glucose (urinary, non-quantitative) 39877 11 70 02 01 Urine Single Test Strips (incl. tablets)
Nitroprusside, ketone (urinary, non-quant.) 39878 11 70 02 01 Urine Single Test Strips (incl. tablets)
Blood, occult, colorimetric, in urine 39879 11 70 02 01 Urine Single Test Strips (incl. tablets)
Indicator method, protein or albumin (urinary, non-quant.) 39880 11 70 02 01 Urine Single Test Strips (incl. tablets)
Photometric method, iron (non-heme) 39881 11 02 01 16 Iron (CC) IC =>12.07.01.04
Atomic absorption, iron (non-heme) 39882 11 02 01 16 Iron (CC) IC =>12.07.01.04
Radio-labeled iron method, iron (non-heme) 39883 12 07 01 04 Iron (IC) CC =>11.02.01.16
Azo-dye, colorimetric, bilirubin & its conjugates (urinary, non-quant.) 39884 11 70 02 90 Other Urine Testing
Analyzer, chemistry (sequential multiple, continuous flow) clinical use 39885 21 01 10 01 CH Hardware + dedicated accessories + software
Analyzer, chemistry (photometric, discrete), for clinical use 39886 21 01 10 01 CH Hardware + dedicated accessories + software
Analyzer, chemistry, micro, for clinical use 39887 21 01 10 01 CH Hardware + dedicated accessories + software
Analyzer, chemistry, centrifugal, for clinical use 39888 21 01 10 01 CH Hardware + dedicated accessories + software
Analyzer, enzyme, for clinical use 39889 21 01 10 01 CH Hardware + dedicated accessories + software
Flame emission photometer for clinical use 39890 21 04 10 01 GE Hardware + dedicated accessories + software
Control for blood-gas, (assayed and unassayed) 39891 11 50 90 01 Blood gas control
Enzyme controls (assayed and unassayed) 39892 11 50 02 01 Enzyme Control Sera
Radioimmunoassay, compound S (11-deoxycortisol) 39893 12 05 01 14 11-Desoxycortisol
Radioimmunoassay, dehydroepiandrosterone (free and sulfate) 39894 12 05 01 02 Dehydro-epiandrosterone Sulphate (incl. DHEA)
Radioimmunoassay, C-peptide of proinsulin 39895 12 06 01 01 C-Peptide
Dinitrophenyl hydrazone measurement (colorimetric), hydroxybutyric 39896 11 01 01 18 Hydroxybutyrate Dehydrogenase
L-isocitrate and NADP (U.V.), isocitric dehydrogenase 39897 11 01 01 90 Other Enzymes
Immunochemical, bence-jones protein 39898 12 01 01 20 Kappa and Lambda chain
Chromium-51, blood volume 39899 00 00 00 00 Not for IVD use
Gold chloride (colorimetric), bromide 39900 12 08 02 90 Other Central Nervous System TDM
Spectral absorb. curve, oxyhemoglobin, carboxyhemoglobin, carbon- 39901 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
ATP and creatine kinase (enzymatic), creatine 39903 11 30 04 01 Multiple Enzymes only - Electrodes/Biosensors
Nitroprusside reaction (qualitative, urine), cystine 39904 12 06 90 90 Other Individual and Specified Hormones
Chromatographic, cystine 39905 12 06 90 90 Other Individual and Specified Hormones
Isoenzyme, electrophoretic, glucose-6-phosphate dehydrogenase 39906 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)

Page 76 of 108
Enzymatic (glutathione reductase), glutathione 39907 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Gas chromatography, pregnanetriol 39908 12 05 01 07 17 OH Progesterone
Radioimmunoassay, progesterone 39909 12 05 01 06 Progesterone
NADH, phosphoglycerate mutase, ATP (U.V.) 2,3-diphosphoglyceric 39910 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Acid, ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric) 39911 11 02 01 90 Other Substrates
NADP reduction (U.V.), glucose-6-phosphate dehydrogenase 39912 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Radioimmunoassay, total estrogen, nonpregnancy 39913 12 05 02 04 Estrone
Radioimmunoassay (two-site solid phase), ferritin 39914 12 07 01 02 Ferritin
Chromatographic, histidine 39915 12 06 90 90 Other Individual and Specified Hormones
Acid, alpha-ketobutyric and NADH (U.V.), hydroxybutyric 39916 11 01 01 18 Hydroxybutyrate Dehydrogenase
Ferrozine (colorimetric) iron binding capacity 39917 11 02 01 17 Iron Binding Capacity - Total (CC) IC =>12.07.01.05
M. lysodeikticus cell (spectrophotometric), lysozyme (muramidase) 39918 11 01 01 24 Lysozyme
Immunochemical, lysozyme (muramidase) 39919 11 01 01 24 Lysozyme
Acid, oxalacetic and nadh oxidation (U.V.), malic dehydrogenase 39920 11 01 01 25 Malate Dehydrogenase
Diazo (colorimetric), nitrite (urinary, non-quant) 39921 11 70 02 01 Urine Single Test Strips (incl. tablets)
2,4-dinitrofluorobenzene (spectroscopic), nitrogen (amino-nitrogen) 39922 12 06 90 90 Other Individual and Specified Hormones
Ninhydrin, nitrogen (amino-nitrogen) 39923 12 06 90 90 Other Individual and Specified Hormones
Glucose-6-phosphate (colorimetric), phosphohexose isomerase 39924 11 01 01 28 Phospho Hexose Isomerase
Radioimmunoassay, pregnenolone 39925 12 05 02 90 Other Pregnancy Testing Hormones
Beta-D-fructose & NADH oxidation (U.V.), sorbitol dehydrogenase 39926 11 01 01 29 Sorbitol Dehydrogenase
N-benzoyl-l-arginine ethyl ester (U.V.), trypsin 39927 11 01 01 30 Trypsin (CC) IC =>12.01.90.07
Infrared spectroscopy measurement, urinary calculi (stone) 39928 00 00 00 00 Not for IVD use
Stannous chloride - hydrazine, phospholipid 39929 11 02 01 24 Phospholipids
Acid, trifluoroacetic, vitamin A, hexane extraction 39930 12 07 02 90 Other Vitamin Tests
Analyzer, heparin, automated 39938 23 02 10 01 HS Hardware + dedicated accessories + software
Hemoglobin M 39939 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
Hemoglobin F quantitation 39940 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
Hemoglobin A2 quantitation 39941 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
Prothrombin-proconvertin and thrombotest 39942 13 02 01 01 Prothrombin time ( Quick Test )
Device, hematocrit measuring 39943 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Electrophoretic, gamma-glutamyl transpeptidase isoenzyme 39944 11 01 01 16 Gamma Glutamyltransferase
Resin, ion-exchange, ascorbic acid, colorimetry, iron binding capacity 39945 11 02 01 17 Iron Binding Capacity - Total (CC) IC =>12.07.01.05
Trinitrobenzene sulfonate (spectroscopic), nitrogen (amino-nitrogen) 39946 12 06 90 90 Other Individual and Specified Hormones
Densitometeric, protein fractionation 39947 21 05 10 01 EP Hardware + dedicated accessories + software
Spectrophotometric, uroporphyrin 39948 11 02 01 90 Other Substrates
Colorimetric, mucopolysaccharide 39949 11 02 01 90 Other Substrates
Antisera, fluorescent, B. parapertussis 39951 15 01 90 07 Bordetella pertussis / parapertussis
Antiserum, fluorescent, Epstein-Barr virus 39952 15 04 04 04 EBV Antibodies
Media, culture, amino acid assay 39953 14 02 05 01 MIC Systems - Manual
Culture media, antibiotic assay 39954 14 02 05 01 MIC Systems - Manual

Page 77 of 108
Culture media, vitamin assay 39955 14 90 90 90 Other Other Microbiology Tests

Culture media, general nutrient broth 39956 14 01 02 01 Broth Media (Tubes)
Culture media, selective broth 39957 14 01 02 01 Broth Media (Tubes)
Culture media, multiple biochemical test 39958 14 02 02 90 Other Manual Identification (Optichin, Bacitracin etc.)
Culture media, non-selective and non-differential 39959 14 01 Bacteriology - Culture
Culture media, non-selective and differential 39960 14 01 Bacteriology - Culture
Culture media, selective and differential 39961 14 01 Bacteriology - Culture
Culture media, selective and non-differential 39962 14 01 Bacteriology - Culture
Supplement, culture media 39963 14 01 01 04 Additives for DCM
Culture media, anaerobic transport 39964 24 09 30 01 Other_MCB Consumables
Culture media, non-propagating transport 39965 24 09 30 01 Other_MCB Consumables
Culture media, propagating transport 39966 24 09 30 01 Other_MCB Consumables
Kit, identification, dermatophyte 39967 14 03 04 90 Other Identification Systems for Yeasts and Fungi - Automated
Kit, identification, Enterobacteriaceae 39968 14 02 02 01 Enterobacteriaceae - Manual
Kit, fastidious organism 39969 14 02 02 90 Other Manual Identification (Optichin, Bacitracin etc.)
Kit, identification, glucose nonfermenter 39970 14 02 02 02 Non-fermenters - Manual
Susceptibility test disc, antimicrobial 39971 24 01 30 01 SI Consumables
Kit, quality control for culture media 39972 14 01 08 90 Miscellaneous Buffers, Controls and Standards
Culture media, for isolation of pathogenic Neisseria 39973 14 02 02 06 Haemophilus & Neisseria - Manual
Culture media, antimicrobial susceptibility test, Mueller Hinton 39974 14 02 05 01 MIC Systems - Manual
Antigen, positive control, Cryptococcus neoformans 39975 15 06 01 90 Other Mycology Immunoassays
Device, blood volume measuring 39976 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
ATP release (luminescence) 39977 12 12 01 90 Other Liver Function
Antigen, CF, Aspergillus spp. 39978 15 06 01 01 Aspergillus
Kit, screening, Trichomonas 39979 15 05 10 90 Other Parasitology
Enzyme immunoassay, benzodiazipine 39981 12 09 01 04 Benzodiazepines
Factor B, antigen, antiserum, control 39993 12 01 02 90 Other Complement Components
Agent, chelating for decalcification 40016 13 02 80 90 Other Auxiliary Reagents (Haemostasis)
Osmium tetroxide 40017 00 00 00 00 Not for IVD use
Paraformaldehyde 40018 00 00 00 00 Not for IVD use
Media, mounting, oil soluble 40020 13 07 01 06 Mounting media (Histology/Cytology)
Media, mounting, water soluble 40021 13 07 01 06 Mounting media (Histology/Cytology)
Methylene blue, tissue stain 40022 13 01 03 01 Histo/Cyto stains
Aniline blue 40023 13 01 03 01 Histo/Cyto stains
Antiserum, positive control, Aspergillus spp. 40024 15 50 01 06 Mycology Controls - Inf.Imm.
Antiserum, positive control, Blastomyces dermatitidis 40025 15 50 01 06 Mycology Controls - Inf.Imm.
Adenine nucleotide quantitation 40039 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Whole blood hemoglobin determination 40040 13 01 02 01 Haemoglobin determinations (Total Hb)
Antigen, ID, HA, CEP, Entamoeba histolytica & rel. spp. 40045 15 05 10 01 Entamoeba histolytica
Slide stainer, contact type 40050 23 05 10 01 HC Hardware + dedicated accessories + software

Page 78 of 108
Slide stainer, immersion type 40051 23 05 10 01 HC Hardware + dedicated accessories + software

Cell, animal and human, cultured 40052 14 04 01 01 Cells for Tissue Culture
Media and component, synthetic cell and tissue culture 40053 14 04 01 01 Cells for Tissue Culture
Media, Mycoplasma detection 40054 14 02 02 07 Mycoplasma - Manual
Auramine O 40055 13 01 03 01 Histo/Cyto stains
Azure C 40056 13 01 03 01 Histo/Cyto stains
Bismarck brown Y 40057 13 01 03 01 Histo/Cyto stains
Brilliant cresyl blue 40058 13 01 03 01 Histo/Cyto stains
Brilliant green 40059 13 01 03 01 Histo/Cyto stains
Carmine 40060 13 01 03 01 Histo/Cyto stains
Chlorazol black E 40061 13 01 03 01 Histo/Cyto stains
Erythrosin B 40062 13 01 03 01 Histo/Cyto stains
Ethyl eosin 40063 13 01 03 01 Histo/Cyto stains
Jenner stain 40064 13 01 03 01 Histo/Cyto stains
Acid, periodic 40065 00 00 00 00 Not for IVD use
Hematoxylin, Ehrlich's 40066 13 01 03 01 Histo/Cyto stains
Basic fuchsin 40067 13 01 03 01 Histo/Cyto stains
Antisera, C. acnes 40070 15 01 90 90 Other Other Bacteriology Immunoassays
Nad reduction (U.V.), phosphohexose isomerase 40071 11 01 01 28 Phospho Hexose Isomerase
Colorimetric uric acid 40084 11 02 01 32 Uric Acid
Media and component, Mycoplasma detection 40096 14 02 02 07 Mycoplasma - Manual
Assay, erythrocytic glucose-6-phosphate dehydrogenase 40102 13 01 09 01 Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)
Assay, fetal hemoglobin 40103 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
Fluorescent proc. (qual.), galactose-1-phosphate uridyl transferase 40105 14 02 05 90 Other Manual Susceptibility Testing
Calibrator for platelet counting 40111 13 01 20 05 Platelet Control
Calibrator for hemoglobin and hematocrit measurement 40112 13 01 20 04 Haemoglobin Control
System for the identification of hepatitis B antigen 40113 15 02 02 01 Hepatitis B Surface Antigen
Solution, copper sulfate for specific gravity determination 40114 13 01 09 90 Other Other Haematology Testing Reagents
Centrifuge, cell-washing, automated for immuno-hematology 40115 28 01 10 01 SP Hardware + accessories + software
System, test, automated blood grouping and antibody 40116 13 03 04 90 Other Antibody Detection (Immunohaematology)
System, test, alpha-fetoprotein, RIA 40120 12 03 90 01 Alphafetoprotein
Reagent, immunoassay, carbonic anhydrase B and C 40121 13 01 90 90 Other Other Haematology Reagents
Radioimmunoassay, conjugated sulfalithocholic (SLCG) acid, bile acid 40127 11 02 01 02 Bile acids
Chromatography (gas), clinical use 40137 21 05 10 02 HPLC Hardware + dedicated accessories + software
High pressure liquid chromatography, cocaine and cocaine metabolite 40138 12 09 01 06 Cocaine + Cocaine Metabolites
High pressure liquid chromatography, methamphetamine 40139 12 09 01 02 Amphetamine/Methamphetamine Specific (+Ecstasy)
EAS chromatography, quinine 40140 12 08 01 09 Quinidine
High pressure liquid chromatography, quinine 40141 12 08 01 09 Quinidine
Drug specific control material 40142 12 50 01 02 TDM/Drug Controls
Radioimmunoassay, cannabinoid 40143 12 09 01 05 Cannabinoids

Page 79 of 108
Procainamide control material 40144 12 50 01 02 TDM/Drug Controls

LDL & VLDL precipitation, HDL 40148 11 02 01 34 Lipoprotein Electrophoresis
LDL & VLDL precipitation, cholesterol via esterase-oxidase, HDL 40149 11 02 01 34 Lipoprotein Electrophoresis
Radioimmunoassay, netilmicin (I-125) 40151 12 08 03 06 Netilmycin
Platelet factor 4 radioimmunoassay 40153 13 02 04 02 Platelet Factor 4
Assay, glycosylated hemoglobin 40154 11 02 01 14 Glycosylated/Glycated Haemoglobin IC=12.06.01.06
Kit, test, pregnancy, HCG, over the counter 40155 12 70 05 02 HCG - Rapid Test
U.V. spectrometry, theophylline 40156 12 08 04 02 Theophylline
U.V. spectrometry, primidone 40157 12 08 02 09 Primidone
U.V. spectrometry, phenobarbital 40158 12 08 02 07 Phenobarbital
U.V. spectrometry, carbamazepine 40159 12 08 02 01 Carbamazepine
U.V. spectrometry, diphenylhydantoin 40160 12 08 02 90 Other Central Nervous System TDM
Colorimetry, acetaminophen 40163 12 09 02 01 Acetaminophene (Paracetamol)
Fixative, acid containing 40164 13 07 01 05 Fixing reagents (Histology/Cytology)
Fixative, metallic containing 40165 13 07 01 05 Fixing reagents (Histology/Cytology)
Fixative, formalin-containing 40166 13 07 01 05 Fixing reagents (Histology/Cytology)
Fixative, alcohol containing 40167 13 07 01 05 Fixing reagents (Histology/Cytology)
U.V. spectrometry, tricyclic antidepressant drug 40170 12 09 02 15 Tricyclic Antidepressants (Total)
High pressure liquid chromatography, tricyclic antidepressant drug 40171 12 09 02 15 Tricyclic Antidepressants (Total)
Acid, uric, acid reduction of ferric ion 40173 11 02 01 32 Uric Acid
Radioreceptor assay, human chorionic gonadotropin 40174 12 05 02 05 Human Chorionic Gonadotropin Total
Fluorescence polarization immunoassay, tobramycin 40175 12 08 03 09 Tobramycin
Enzyme linked immunoabsorbent assay, Herpes simplex virus 40176 15 04 03 04 HSV Antibodies - Total
Enzyme linked immunoabsorbent assay, Toxoplasma gondii 40177 15 05 01 06 Toxoplasma Antibody IgM
Fluorescence polarization immunoassay, amibacin 40179 12 08 03 90 Other Antibiotics TDM
Assay, Bart's, hemoglobin 40180 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
Fluorescence polarization immunoassay, phenobarbital 40183 12 08 02 07 Phenobarbital
Fluorescence polarization immunoassay, theophylline 40184 12 08 04 02 Theophylline
Reagent, antibody, Legionella, direct & indirect fluorescent 40188 15 01 05 03 Legionella Antibody Assays
Antigen, all groups, Shigella spp. 40193 15 01 90 14 Shigella
Device, general purpose, microbiology, diagnostic 40194 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Antiserum, coagglutination (direct) Neisseria gonorrhoeae 40195 15 01 02 03 Gonococcal Antibody Assays Total
Peroxidase anti-peroxidase immunohistochemical stain 40197 14 01 08 02 Other Stains
Antisera, conjugated fluorescent, cytomegalovirus 40199 15 04 02 04 CMV Antibodies - Total
Enzyme linked immunoabsorption assay, Treponema pallidum 40200 15 01 03 03 Syphilis Antibody Assays Total
Enzyme linked immunoabsorbent assay, rotavirus 40201 15 04 80 06 Rotavirus
Assay, T lymphocyte surface marker 40202 13 05 01 01 Antibodies for B and T-cell subtyping
Enzyme linked immunoabsorbent assay, (Chlamydiae group) 40203 15 01 01 03 Chlamydia Antibody Assays Total
Assay, B lymphocyte marker 40204 13 05 01 01 Antibodies for B and T-cell subtyping
Antisera, IF, Toxoplasma gondii 40206 15 05 01 04 Toxoplasma Antibody (Total)

Page 80 of 108
Antinuclear antibody (enzyme-labeled), antigen, control 40208 12 10 01 01 ANA Screening

Antibody IgM, IF, Epstein-Barr virus 40209 15 04 04 04 EBV Antibodies
Culture media, antimicrobial susceptibility test 40211 14 02 05 01 MIC Systems - Manual
Antigen, indirect hemagglutination (IHA) Herpes simplex virus 40212 15 04 03 01 HSV Antigen
Antisera, immunoperoxidase, Chlamydia spp. 40214 15 01 01 03 Chlamydia Antibody Assays Total
Antisera, fluorescent, Chlamydia spp. 40215 15 01 01 03 Chlamydia Antibody Assays Total
Alpha-1-acid-glycoprotein, antigen, antiserum, control 40216 12 01 90 01 a1-Acid Glycoprotein ( Orosomucoid )
Counter, urine particle 40217 21 01 10 01 CH Hardware + dedicated accessories + software
Anti-RNP antibody, antigen and control 40218 12 10 90 20 Ribosomal Phosphoprotein Antibodies
Analyzer, chromosome, automated 40225 29 01 10 01 Other Hardware + dedicated accessories + software
Kit, test, alpha-fetoprotein for testicular cancer 40226 12 03 90 01 Alphafetoprotein
Kit, test, alpha-fetoprotein for neural tube defect 40227 12 03 90 01 Alphafetoprotein
Hepatitis A test (antibody and IgM antibody) 40228 15 02 01 06 HAV Antibody IgM
Hepatitis B test (B core, Be antigen, Be antibody, and B core IgM) 40229 15 02 02 40 Hepatitis B Virus - NA Reagents
Reagent, Leishmanii serological 40230 14 05 02 90 Other Parasite Antigen Detection
Device, general purpose, hematology 40231 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
DNA-reagent, Campylobacter spp. 40239 15 01 14 40 Campylobacter Detection by NA Reagents
Candida spp., direct antigen, ID 40243 15 06 01 02 Candida albicans
Anti-DNA antibody (enzyme-labeled), antigen, control 40246 12 10 01 05 ds DNA - Antibodies
DNA-reagent, Chlamydia 40254 15 01 01 40 Chlamydia Detection by NA Reagents
DNA-reagent, Salmonella spp. 40255 15 01 10 40 Salmonella Detection by NA Reagents
Reagent, borrelia serological reagent 40256 14 02 03 01 Serotyping (E.coli, Salmonella, Shigella, etc.)
Anti-DNA antibody, antigen and control 40257 12 10 01 05 ds DNA - Antibodies
Prostate-specific antigen (PSA) for management of prostate cancer 40258 12 03 01 32 Total Prostatic Specific Antigen
Calibrator for alpha-fetoprotein in mid-pregnancy maternal serum 40260 12 50 01 09 Tumour Marker Standards / Calibrators
Test reagent, Neisseria gonorrhoeae biochemical 40261 15 01 02 03 Gonococcal Antibody Assays Total
Analyzer, hydrogen gas 40269 00 00 00 00 Not for IVD use
Column, adsorption, low density, lipoprotein 40272 11 02 01 21 Low Density Lipoprotein Cholesterol
DNA-probe, B and T lymphocyte 40294 13 05 01 01 Antibodies for B and T-cell subtyping
Assay, interleukin 40295 13 06 01 11 Interleukins (IL-1,IL-1A,IL-1B,.. - IL-15)
DNA-probe, human chromosome 40296 16 01 03 Chromosomal Disorders
Cyclosporine and matabolite serum assay 40297 12 08 06 01 Cyclosporine Total
Respiratory syncytial virus - ELISA 40300 15 04 80 05 Respiratory Syncytial Virus (RSV)
DNA-probe, agent, Listeria 40301 15 01 13 40 Listeria Detection by NA Reagents
DNA-probe - Blastomyces dermatitidis 40310 15 06 01 90 Other Mycology Immunoassays
Assay, serum sialic acid 40319 11 02 01 90 Other Substrates
Kit, RIA, antigen & kit, prostatic acid phosphatase 40320 12 03 01 37 Prostatic Acid Phosphatase (IC) CC =>11.01.01.02
C. trachomatis (chlamydia group) 40328 15 01 01 Chlamydia
High performance liquid chromatography for cyclosporine 40332 12 08 06 01 Cyclosporine Total
Fluroesence polorization immunoassay for cyclosporine 40333 12 08 06 01 Cyclosporine Total

Page 81 of 108
Radioimmunoassay for cyclosporine 40334 12 08 06 01 Cyclosporine Total

Enzyme immunoassay for gamma-enolase 40335 12 03 90 08 Neuron Specific Enolase
Radioimmunoassay for prostate-specific antigen 40336 12 03 01 32 Total Prostatic Specific Antigen
Strip, test isoniazid 40338 11 70 02 01 Urine Single Test Strips (incl. tablets)
Enzyme linked immunosorbent assay, T. cruzi 40343 15 05 10 02 Chagas
Enzyme linked immunosorbent assay, Coccidioides immitis 40344 15 06 01 90 Other Mycology Immunoassays
Enzyme linked immunoabsorbent assay, Histoplasma capsulatum 40345 15 06 01 90 Other Mycology Immunoassays
Culture media, antimycobacteria, susceptibility test 40347 14 02 05 01 MIC Systems - Manual
Culture media, antifungal, susceptibility test 40348 14 03 06 Susceptibility Testing (Mycology)
Legionella, spp., ELISA 40350 15 01 05 01 Legionella Antigen Detection
Enzyme immunoassasy, nocotine and nicotine metabolite 40354 12 09 01 08 Cotinine
Thin layer chroomatography, tricyclic antidepressant drug 40356 12 09 02 15 Tricyclic Antidepressants (Total)
Hemoglobin C (abnormal hemoglobin variant) 40357 13 01 02 02 Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1)
Anti-ribosomal P antibody 40379 12 10 90 20 Ribosomal Phosphoprotein Antibodies
Bilirubin (total and unbound) in the neonate test system 40381 11 02 01 03 Bilirubin
Enzyme linked immunosorbent assay, thrombus precursor protein 40386 12 01 90 90 Other Other Plasma Proteins
System, test, vitamin D 40387 12 07 02 90 Other Vitamin Tests
System, test, low density, lipoprotein 40393 11 02 01 21 Low Density Lipoprotein Cholesterol
Apolipoprotein 40403 12 01 04 21 Lipoprotein ( a )
Immunoassay for blood tacrolimus 40404 12 08 06 03 Tacrolimus
System, test, lipoprotein (A) 40405 12 01 04 21 Lipoprotein ( a )
Test, urea (breath or blood) 40406 11 02 01 04 Urea/Blood Urea Nitrogen
Antibody, gliadin 40408 12 10 90 06 Gliadin Antibodies
System, test, thyroglobulin 40409 12 04 01 08 Thyroglobulin
Total, prostate specific antigen (noncomplexed & complexed) for 40414 12 03 01 32 Total Prostatic Specific Antigen
Test, prostate specific antigen, free, (noncomplexed) to distinguish 40415 12 03 01 32 Total Prostatic Specific Antigen
Kit, sample collection, HIV 40417 25 01 30 01 II Consumables
Antibody to HTLV-1, ELISA 40418 15 03 30 04 HTLV I Antibody
Biosensor, immunoassay, myoglobin 40435 12 13 01 05 Myoglobin
Kit, western blot, HIV-1 40436 15 03 01 07 HIV 1 Antibody - Confirmatory
Antibody, monoclonal blocking, HIV-1 40437 15 03 01 04 HIV 1 Antibody (Total)
Monoclonal, HIV-1 40438 15 03 01 04 HIV 1 Antibody (Total)
System, test, home, HIV-1 40439 15 03 01 04 HIV 1 Antibody (Total)
Immunohistochemistry assay, antibody, progesterone receptor 40441 12 03 02 02 Progesterone Receptor Assays
Assay,enzyme linked immunosorbent,tetanus antibody test 40442 15 01 90 09 Tetanus (Clostridium T.)
Assay, enzyme linked immunosorbent, parvovirus B19 IgG 40443 15 04 80 09 Parvovirus B 19
Assay, enzyme linked immunosorbent, parvovirus B19 IgM 40444 15 04 80 09 Parvovirus B 19
Biosensor, immunoassay, CPK or isoenzyme 40445 12 13 01 02 Creatine Kinase - MB "Mass" (IC) CC =>11.01.01.14.00
Assay, enzyme linked immunosorbent, hepatitis C virus 40446 15 02 03 04 HCV Antibody (Total)
System, test, sodium, enzymatic method 40447 11 03 01 10 Sodium

Page 82 of 108
Test, system, potassium, enzymatic method 40448 11 03 01 09 Potassium

Antigen (complexed), prostate specific, (CPSA) 40449 12 03 01 34 Complexed Prostatic Specific Antigen
Lipoprotein, high density, HDL, OTC 40450 11 02 01 15 High Densitiy Lipoprotein Cholesterol
Test, natriuretic peptide 40452 12 13 01 01 Atrial- Brain Natriuric Peptide (incl. Pro-ANP/BNP)
Human immunodeficiency virus 1 antigen control 40454 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human immunodeficiency virus 1 antigen calibrator 40455 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human immunodeficiency virus 1 antigen p24 confirmatory control 40456 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human immunodeficiency virus 1 antigen p24 confirmatory calibrator 40457 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human immunodeficiency virus 1 antigen/antibody dissociation kit 40458 15 03 01 90 Other HIV 1 Reagents
Human immunodeficiency virus 1 antigen/antibody dissociation control 40459 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human immunodeficiency virus 1 antigen/antibody dissociation 40460 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human immunodeficiency virus 1 antigen neutralization kit 40461 15 03 01 01 HIV 1 Antigen
Human immunodeficiency virus 1 antigen neutralization control 40462 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human immunodeficiency virus 1 antigen neutralization calibrator 40463 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human immunodeficiency virus 1 antigen p24 control 40465 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human immunodeficiency virus 1 antigen p24 calibrator 40466 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human immunodeficiency virus 1 antigen p24 confirmatory kit 40467 15 03 10 90 Other HIV P24 Reagents
HIV1 antigen P24 neutralization kit 40472 15 03 10 01 HIV P24 Antigen
HIV-1 antigen p24 neutralization control 40473 15 50 01 03 Retrovirus Controls - Inf.Imm.
HIV-1 antigen p24 neutralization calibrator 40474 15 50 01 03 Retrovirus Controls - Inf.Imm.
Fibrin degradation product 40489 13 02 05 02 Fibrinogen Degradation Products
CO2 incubator 40492 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Incubator, laboratory, carbon dioxide 40520 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Chamber, incubator CO2 40521 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Laboratory equipment, thermostat heating/cooling 40527 00 00 00 00 Not for IVD use
Laboratory equipment, view box, ultraviolet 40734 23 03 10 01 BG Hardware + dedicated accessories + software
Centrifuge rotor, <specify> 41198 28 01 10 01 SP Hardware + accessories + software
Culture medium, blood, paediatric, automated 41227 14 01 06 02 Paediatric Bottles (Blood Culture -Autom.)
Vitamin D control, 25-hydroxyvitamin D3 41252 12 50 01 12 Anaemia Related/Vitamin Controls
Vitamin D calibrator, 25-hydroxyvitamin D3 41253 12 50 01 11 Anaemia Related/Vitamin Standards and Calibrators
Alpha1-antitrypsin calibrator 41254 12 50 01 05 Specific Protein Standards / Calibrators
Alpha1-antitrypsin control 41255 12 50 01 06 Specific Protein Controls
Alpha1-microglobulin calibrator 41258 12 50 01 05 Specific Protein Standards / Calibrators
Alpha1-microglobulin control 41259 12 50 01 06 Specific Protein Controls
Alpha2-macroglobulin calibrator 41260 12 50 01 05 Specific Protein Standards / Calibrators
Alpha2-macroglobulin control 41261 12 50 01 06 Specific Protein Controls
ABO grouping cell calibrator 41262 13 03 20 02 Control Kits (Immunohaematology)
ABO grouping cell control 41263 13 03 20 02 Control Kits (Immunohaematology)
ABO serum calibrator 41265 13 03 20 02 Control Kits (Immunohaematology)
ABO serum control 41266 13 03 20 02 Control Kits (Immunohaematology)

Page 83 of 108
Alpha2-pregnancy-associated glycoprotein calibrator 41268 12 50 01 03 Hormone Standards / Calibrators

Alpha2-pregnancy-associated glycoprotein control 41269 12 50 01 04 Hormone Controls
Antinuclear antibody calibrator 41270 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Antinuclear antibody control 41271 12 50 01 14 Rheumatoid/Autoimmune Controls
Adenovirus calibrator 41272 15 50 01 04 Other Virology Controls - Inf.Imm.
Adenovirus control 41273 15 50 01 04 Other Virology Controls - Inf.Imm.
Adenovirus kit 41274 15 04 80 01 Adenovirus
Anti-B2-glycoprotein I antibody calibrator 41275 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Anti-B2-glycoprotein I antibody control 41276 12 50 01 14 Rheumatoid/Autoimmune Controls
Antiganglioside total antibody calibrator 41277 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Antiganglioside total antibody control 41278 12 50 01 14 Rheumatoid/Autoimmune Controls
Anticardiolipin antibody calibrator 41279 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Anticardiolipin antibody control 41280 12 50 01 14 Rheumatoid/Autoimmune Controls
Anti-GD1b antibody calibrator 41281 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Anti-GD1b antibody control 41282 12 50 01 14 Rheumatoid/Autoimmune Controls
Anti-GM1 antibody calibrator 41283 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Anti-GM1 antibody control 41284 12 50 01 14 Rheumatoid/Autoimmune Controls
Antihistamine antibody calibrator 41285 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Antihistamine antibody control 41286 12 50 01 14 Rheumatoid/Autoimmune Controls
Anti-Hu antibody calibrator 41287 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Anti-Hu antibody control 41288 12 50 01 14 Rheumatoid/Autoimmune Controls
Antimyelin-associated glycoprotein calibrator 41289 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Antimyelin-associated glycoprotein control 41290 12 50 01 14 Rheumatoid/Autoimmune Controls
Antimitochondrial antibody calibrator 41291 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Antimitochondrial antibody control 41292 12 50 01 14 Rheumatoid/Autoimmune Controls
Antiphosphatidylserine antibody calibrator 41293 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Antiphosphatidylserine antibody control 41294 12 50 01 14 Rheumatoid/Autoimmune Controls
Anti-Ri antibody calibrator 41295 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Anti-Ri antibody control 41296 12 50 01 14 Rheumatoid/Autoimmune Controls
Antistreptococcal Dnase B calibrator 41297 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Antistreptococcal Dnase B control 41298 12 50 01 14 Rheumatoid/Autoimmune Controls
Antistreptococcal hyaluronidase calibrator 41299 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Antistreptococcal hyaluronidase control 41300 12 50 01 14 Rheumatoid/Autoimmune Controls
Antistreptokinase antibody calibrator 41301 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Antistreptokinase antibody control 41302 12 50 01 14 Rheumatoid/Autoimmune Controls
Antihuman immunoglubulin polyvalent antiserum calibrator 41303 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Antihuman immunoglobulin polyvalent antiserum control 41304 12 50 01 14 Rheumatoid/Autoimmune Controls
Anti-Yo blood group antibody calibrator 41305 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Anti-Yo blood group antibody control 41306 12 50 01 14 Rheumatoid/Autoimmune Controls
B/T-cell subtyping antibody calibrator 41307 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators

Page 84 of 108
B/T-cell subtyping antibody control 41308 12 50 01 14 Rheumatoid/Autoimmune Controls

Human leukocyte antigen class II determinant antibody calibrator 41309 13 04 01 04 HLA Control Cells
Human leukocyte antigen class II determinant antibody control 41310 13 04 01 04 HLA Control Cells
Lymphocyte subtyping antibody calibrator 41311 13 05 01 06 Antibodies for Lymphocyte subtyping
Lymphocyte subtyping antibody control 41312 13 05 01 06 Antibodies for Lymphocyte subtyping
Lymphoma subtyping antibody calibrator 41313 13 05 01 03 Antibodies for lymphoma typing(except B-&T-cell typing)
Lymphoma subtyping antibody control 41314 13 05 01 03 Antibodies for lymphoma typing(except B-&T-cell typing)
Cell surface receptor recognizing antibody calibrator 41315 13 05 01 04 Antibodies for recognizing cell surface receptors
Cell surface receptor recognizing antibody control 41316 13 05 01 04 Antibodies for recognizing cell surface receptors
Leukaemia subtyping antibody calibrator 41317 13 05 01 05 Antibodies for subtyping of leukemia(except B-&T-cell typing)
Leukaemia subtyping antibody control 41318 13 05 01 05 Antibodies for subtyping of leukemia(except B-&T-cell typing)
Anticytoplasmic antibody calibrator 41319 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Anticytoplasmic antibody control 41320 12 50 01 14 Rheumatoid/Autoimmune Controls
Ceruloplasmin calibrator 41321 12 50 01 05 Specific Protein Standards / Calibrators
Ceruloplasmin control 41322 12 50 01 06 Specific Protein Controls
Cryptosporidium calibrator 41326 14 50 01 90 Other Controls Microbiology
Vitamin B6 calibrator 41331 12 50 01 11 Anaemia Related/Vitamin Standards and Calibrators
Vitamin B6 control 41332 12 50 01 12 Anaemia Related/Vitamin Controls
Transferrin calibrator 41343 12 50 01 05 Specific Protein Standards / Calibrators
Transferrin control 41344 12 50 01 06 Specific Protein Controls
Extractable nuclear antigen calibrator 41346 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Extractable nuclear antigen control 41347 12 50 01 14 Rheumatoid/Autoimmune Controls
Immunoglobulin E monotest/monoresult multiantigen calibrator 41348 12 50 01 05 Specific Protein Standards / Calibrators
Immunoglobulin E monotest/monoresult multiantigen control 41349 12 50 01 06 Specific Protein Controls
Immunoglobulin E monotest/pluriresult multiantigen calibrator 41350 12 50 01 05 Specific Protein Standards / Calibrators
Immunoglobulin E monotest/pluriresult multiantigen control 41351 12 50 01 06 Specific Protein Controls
Immunoglobulin G calibrator 41352 12 50 01 05 Specific Protein Standards / Calibrators
Immunoglobulin G control 41353 12 50 01 06 Specific Protein Controls
Immunoglobulin G subclass calibrator 41354 12 50 01 05 Specific Protein Standards / Calibrators
Immunoglobulin G subclass control 41355 12 50 01 06 Specific Protein Controls
Immunoglobulin M calibrator 41356 12 50 01 05 Specific Protein Standards / Calibrators
Immunoglobulin M control 41357 12 50 01 06 Specific Protein Controls
Immunoglobulin M subclass calibrator 41358 12 50 01 05 Specific Protein Standards / Calibrators
Immunoglobulin M subclass control 41359 12 50 01 06 Specific Protein Controls

Page 85 of 108
Immunohistologic calibrator 41360 13 07 01 11 Immunohistology kits

Immunohistologic control 41361 13 07 01 11 Immunohistology kits
Insulin-like growth factor binding protein 3 calibrator 41362 12 50 01 15 Individual and Specified Hormones Calibrators
Insulin-like growth factor binding protein 3 control 41363 12 50 01 16 Individual and Specified Hormones Controls
Insulin-like growth factor II calibrator 41364 12 50 01 15 Individual and Specified Hormones Calibrators
Insulin-like growth factor II control 41365 12 50 01 16 Individual and Specified Hormones Controls
Insulin antibody calibrator 41367 12 50 01 15 Individual and Specified Hormones Calibrators
Insulin antibody control 41368 12 50 01 16 Individual and Specified Hormones Controls
Interferon a/B/y calibrator 41369 13 06 01 01 Interferons (a,b,y)
Interferon a/B/y control 41370 13 06 01 01 Interferons (a,b,y)
Interleukin IL-1a/IL1b/IL1RA/IL2r/IL6r calibrator 41371 13 06 01 12 Interleukins Receptors(IL-2R,IL6R ...)
Interleukin IL-1a/IL1b/IL1RA/IL2r/IL6r control 41372 13 06 01 12 Interleukins Receptors(IL-2R,IL6R ...)
Interleukin IL-1/IL-12 calibrator 41373 13 06 01 11 Interleukins (IL-1,IL-1A,IL-1B,.. - IL-15)
Interleukin IL-1/IL-12 control 41374 13 06 01 11 Interleukins (IL-1,IL-1A,IL-1B,.. - IL-15)
Plasma protein kit 41375 12 01 90 90 Other Other Plasma Proteins
Plasmodium falciparum calibrator 41376 14 50 01 90 Other Controls Microbiology
Plasmodium falciparum control 41377 14 50 01 90 Other Controls Microbiology
Pneumocystis carinii calibrator 41378 14 50 01 90 Other Controls Microbiology
Pneumocystis carinii control 41379 14 50 01 90 Other Controls Microbiology
Platelet calibrator 41380 13 01 20 05 Platelet Control
Polyspecific antihuman serum calibrator 41383 13 03 20 02 Control Kits (Immunohaematology)
Polyspecific antihuman serum control 41384 13 03 20 02 Control Kits (Immunohaematology)
Proteinase 3-antineutrophil cytoplasmic autoantibody calibrator 41385 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Proteinase 3-antineutrophil cytoplasmic autoantibody control 41386 12 50 01 14 Rheumatoid/Autoimmune Controls
Prealbumin/transthyretin calibrator 41387 12 50 01 05 Specific Protein Standards / Calibrators
Prealbumin/transthyretin control 41388 12 50 01 06 Specific Protein Controls
Jo-1 antibody calibrator 41389 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Jo-1 antibody control 41390 12 50 01 14 Rheumatoid/Autoimmune Controls
Erythropoietin calibrator 41391 12 50 01 11 Anaemia Related/Vitamin Standards and Calibrators
Erythropoietin control 41392 12 50 01 12 Anaemia Related/Vitamin Controls
Monoethylglycinexylidide calibrator 41393 12 50 01 80 Other Standards / Calibrators Immunochemistry
Monoethylglycinexylidide control 41394 12 50 01 90 Other Controls Immunochemistry
Melatonine calibrator 41395 12 50 01 15 Individual and Specified Hormones Calibrators
Melatonine control 41396 12 50 01 16 Individual and Specified Hormones Controls
Myosin light chain calibrator 41398 12 50 01 07 Cardiac Marker Standards / Calibrators
Haemoglobin calibrator 41399 13 01 20 04 Haemoglobin Control
Haemoglobin control 41400 13 01 20 04 Haemoglobin Control
Haemoglobin subtype calibrator 41401 13 01 20 04 Haemoglobin Control
Haemoglobin subtype control 41402 13 01 20 04 Haemoglobin Control
Haemostasis buffer calibrator 41403 13 02 80 90 Other Auxiliary Reagents (Haemostasis)

Page 86 of 108
Haemostasis buffer control 41404 13 02 80 90 Other Auxiliary Reagents (Haemostasis)

Haptoglobin calibrator 41405 12 50 01 05 Specific Protein Standards / Calibrators
Haptoglobin control 41406 12 50 01 06 Specific Protein Controls
Human papillomavirus calibrator 41407 15 50 01 04 Other Virology Controls - Inf.Imm.
Human papillomavirus control 41408 15 50 01 04 Other Virology Controls - Inf.Imm.
Lactoferrin calibrator 41409 12 50 01 05 Specific Protein Standards / Calibrators
Lactoferrin control 41410 12 50 01 06 Specific Protein Controls
Lymphocyte stabilizing media calibrator 41411 13 04 01 07 Lymphocyte stabilizing media
Lymphocyte stabilizing media control 41412 13 04 01 07 Lymphocyte stabilizing media
Lymphocyte stabilizing media kit 41413 13 04 01 07 Lymphocyte stabilizing media
Leukotriene stimulation test calibrator 41414 12 50 01 05 Specific Protein Standards / Calibrators
Leukotriene stimulation test control 41415 12 50 01 06 Specific Protein Controls
Leukotriene stimulation test kit 41416 12 02 01 07 Leukotriene Stimulation test
Lipoprotein A calibrator 41417 12 50 01 05 Specific Protein Standards / Calibrators
Lipoprotein A control 41418 12 50 01 06 Specific Protein Controls
Lipoprotein A kit 41419 12 01 04 21 Lipoprotein ( a )
Liver-kidney microsome 1/related protein antibody calibrator 41420 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Liver-kidney microsome 1/related protein antibody control 41421 12 50 01 14 Rheumatoid/Autoimmune Controls
Lymphocyte separation media calibrator 41425 13 04 01 06 Lymphocyte separation media
Lymphocyte separation media control 41426 13 04 01 06 Lymphocyte separation media
Lymphocyte separation media kit 41427 13 04 01 06 Lymphocyte separation media
Glandular fever calibrator 41428 13 01 20 90 Other Haematology Controls
Glandular fever control 41429 13 01 20 90 Other Haematology Controls
Kappa/lambda chain calibrator 41430 12 50 01 05 Specific Protein Standards / Calibrators
Kappa/lambda chain control 41431 12 50 01 06 Specific Protein Controls
Prepared media in plates, bacteriology 41493 14 01 04 Prepared Media in Plates (Bacteriology)
Tube, centrifuge 41509 28 01 10 01 SP Hardware + accessories + software
Adaptor, centrifuge tube 41594 28 01 10 01 SP Hardware + accessories + software
Alkaline phosphatase isoenzyme calibrator 41657 11 50 02 01 Enzyme Control Sera
Dispenser, liquid, laboratory, electronic 41663 28 01 10 01 SP Hardware + accessories + software
Alkaline phosphatase isoenzyme control 41686 11 50 02 01 Enzyme Control Sera
5-aminolevulinate dehydratase calibrator 41689 12 50 01 01 TDM/Drug Standards / Calibrators
5-aminolevulinate dehydratase control 41690 12 50 01 02 TDM/Drug Controls
Antiphospholipid antibody control 41691 13 02 50 90 Other Haemostasis Controls
Antiphospholipid antibody calibrator 41692 13 02 50 90 Other Haemostasis Controls
Activated protein C resistance control 41694 13 02 50 90 Other Haemostasis Controls
Activated protein C resistance calibrator 41695 13 02 50 90 Other Haemostasis Controls
Aspartate aminotransferase total activity control 41697 11 50 02 01 Enzyme Control Sera
Aspartate aminotransferase total activity calibrator 41698 11 50 03 02 Calibrators Single Component (CC)
Coagulation factor II control 41699 13 02 50 90 Other Haemostasis Controls

Page 87 of 108
Coagulation factor II calibrator 41700 13 02 50 90 Other Haemostasis Controls

Stain, light microscopy, haematology 41701 13 01 03 01 Histo/Cyto stains
Coagulation factor high molecular weight (HMW) kininogen control 41702 13 02 50 90 Other Haemostasis Controls
Fitzgerald control 41703 13 01 03 90 Other Haematology stains
Fitzgerald calibrator 41704 13 01 03 90 Other Haematology stains
Coagulation factor high molecular weight (HMW) kininogen calibrator 41705 13 02 50 90 Other Haemostasis Controls
Vanilmandelic acid control 41708 12 50 01 02 TDM/Drug Controls
Vanilmandelic acid calibrator 41709 12 50 01 01 TDM/Drug Standards / Calibrators
Thyroglobulin control 41711 12 50 01 04 Hormone Controls
Thyroglobulin calibrator 41712 12 50 01 03 Hormone Standards / Calibrators
Thrombin-antithrombin III-complex calibrator 41724 13 02 50 01 Calibration Plasmas
Thrombin-antithrombin III-complex control 41725 13 02 50 02 Control Plasmas
Lactate dehydrogenase total activity control 41726 11 50 02 01 Enzyme Control Sera
Lactate dehydrogenase total activity calibrator 41727 11 50 03 02 Calibrators Single Component (CC)
Low density lipoprotein calibrator 41728 11 50 03 02 Calibrators Single Component (CC)
Low density lipoprotein control 41729 11 50 02 02 Lipid Control Sera
Lysergic acid diethylamide calibrator 41730 12 50 01 01 TDM/Drug Standards / Calibrators
Lysergic acid diethylamide control 41731 12 50 01 02 TDM/Drug Controls
Myoglobin control 41732 12 50 01 08 Cardiac Marker Controls
Myoglobin calibrator 41733 12 50 01 07 Cardiac Marker Standards / Calibrators
Neonatal thyroid stimulating hormone calibrator 41734 12 50 01 03 Hormone Standards / Calibrators
Neonatal thyroid stimulating hormone control 41735 12 50 01 04 Hormone Controls
Non-esterified fatty acid calibrator 41737 11 50 03 02 Calibrators Single Component (CC)
Non-esterified fatty acid control 41738 11 50 02 90 Other Specific Control Sera (CC)
Nortriptyline calibrator 41740 12 50 01 01 TDM/Drug Standards / Calibrators
Nortriptyline control 41741 12 50 01 02 TDM/Drug Controls
Prothrombin fragment 1+2 calibrator 41742 13 02 50 01 Calibration Plasmas
Prothrombin fragment 1+2 control 41743 13 02 50 02 Control Plasmas
Protoporphyrin calibrator 41744 12 50 01 01 TDM/Drug Standards / Calibrators
Protoporphyrin control 41745 12 50 01 02 TDM/Drug Controls
Reverse triiodothyronine calibrator 41746 12 50 01 03 Hormone Standards / Calibrators
Reverse triiodothyronine control 41747 12 50 01 04 Hormone Controls
Salicylate calibrator 41748 12 50 01 01 TDM/Drug Standards / Calibrators
Salicylate control 41749 12 50 01 02 TDM/Drug Controls
Stain, light microscopy, microbiology 41750 13 01 03 01 Histo/Cyto stains
Serotonin calibrator 41751 12 50 01 05 Specific Protein Standards / Calibrators
Serotonin control 41752 12 50 01 06 Specific Protein Controls
Sisomycin calibrator 41753 12 50 01 01 TDM/Drug Standards / Calibrators
Sisomycin control 41754 12 50 01 02 TDM/Drug Controls
Platelet kit 41755 13 02 04 01 Aggregation Factors

Page 88 of 108
Influenza/parainfluenza calibrator 41757 15 50 01 04 Other Virology Controls - Inf.Imm.

Influenza/parainfluenza control 41758 15 50 01 04 Other Virology Controls - Inf.Imm.
Varicella-zoster kit 41759 15 04 80 10 Varicella Zoster
Cytomegalovirus nucleic acid calibrator 41761 15 50 01 04 Other Virology Controls - Inf.Imm.
Cytomegalovirus nucleic acid control 41764 15 50 01 04 Other Virology Controls - Inf.Imm.
Immunoglobulin A calibrator 41765 12 50 01 05 Specific Protein Standards / Calibrators
Immunoglobulin A control 41766 12 50 01 06 Specific Protein Controls
Myosin light chain control 41767 12 50 01 08 Cardiac Marker Controls
Immunoglobulin A subclass calibrator 41768 12 50 01 05 Specific Protein Standards / Calibrators
Immunoglobulin A subclass control 41769 12 50 01 06 Specific Protein Controls
Immunoglobulin D calibrator 41770 12 50 01 05 Specific Protein Standards / Calibrators
Immunoglobulin D control 41771 12 50 01 06 Specific Protein Controls
Immunoglobulin D subclass calibrator 41772 12 50 01 05 Specific Protein Standards / Calibrators
Immunoglobulin D subclass control 41773 12 50 01 06 Specific Protein Controls
Troponin calibrator 41775 12 50 01 07 Cardiac Marker Standards / Calibrators
Troponin control 41776 12 50 01 08 Cardiac Marker Controls
Androstenedione calibrator 41779 12 50 01 03 Hormone Standards / Calibrators
Androstenedione control 41780 12 50 01 04 Hormone Controls
Amanitin calibrator 41782 12 50 01 80 Other Standards / Calibrators Immunochemistry
Amanitin control 41783 12 50 01 90 Other Controls Immunochemistry
Brucella calibrator 41784 15 50 01 01 Bacteriology Controls - Inf.Imm.
Brucella control 41785 15 50 01 01 Bacteriology Controls - Inf.Imm.
Yersinia calibrator 41788 15 50 01 01 Bacteriology Controls - Inf.Imm.
Yersinia control 41789 15 50 01 01 Bacteriology Controls - Inf.Imm.
Stain, light microscopy, cytology/histology 41792 13 01 03 01 Histo/Cyto stains
Bombesin calibrator 41793 12 50 01 15 Individual and Specified Hormones Calibrators
Bombesin control 41794 12 50 01 16 Individual and Specified Hormones Controls
Adrenocorticotropic hormone calibrator 41795 12 50 01 15 Individual and Specified Hormones Calibrators
Adrenocorticotropic hormone control 41796 12 50 01 16 Individual and Specified Hormones Controls
Entamoeba calibrator 41797 15 50 01 05 Parasitology Controls - Inf.Imm.
Entamoeba control 41798 15 50 01 05 Parasitology Controls - Inf.Imm.
Anti-cancer associated retinopathy calibrator 41799 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Anti-cancer associated retinopathy control 41800 12 50 01 14 Rheumatoid/Autoimmune Controls
Blood group antibody 2 cell screening calibrator 41802 13 03 20 02 Control Kits (Immunohaematology)
Blood group antibody 2 cell screening control 41803 13 03 20 02 Control Kits (Immunohaematology)
Antibody 3 cell screening calibrator 41804 13 03 20 02 Control Kits (Immunohaematology)
Antibody 3 cell screening control 41805 13 03 20 02 Control Kits (Immunohaematology)
Antibody identification cell panel calibrator 41806 13 03 20 02 Control Kits (Immunohaematology)
Antibody identification cell panel control 41807 13 03 20 02 Control Kits (Immunohaematology)
Apolipoprotein A-I calibrator 41808 12 50 01 05 Specific Protein Standards / Calibrators

Page 89 of 108
Apolipoprotein A-I control 41809 12 50 01 06 Specific Protein Controls

Apolipoprotein A-II calibrator 41810 12 50 01 05 Specific Protein Standards / Calibrators
Apolipoprotein A-II control 41811 12 50 01 06 Specific Protein Controls
Apolipoprotein B calibrator 41812 12 50 01 05 Specific Protein Standards / Calibrators
Apolipoprotein B control 41813 12 50 01 06 Specific Protein Controls
Apolipoprotein E genotyping calibrator 41814 12 50 01 05 Specific Protein Standards / Calibrators
Apolipoprotein E genotyping control 41815 12 50 01 06 Specific Protein Controls
Asialo-GM1 calibrator 41816 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Asialo-GM1 control 41817 12 50 01 14 Rheumatoid/Autoimmune Controls
Glucose calibrator 41818 11 50 03 02 Calibrators Single Component (CC)
Glucose control 41819 11 50 02 05 Diabetes Controls
Assayed multicomponent serum calibrator, abnormal 41820 11 50 01 01 Assayed Multicomponent Sera (CC)
Assayed multicomponent serum control, abnormal 41821 11 50 01 01 Assayed Multicomponent Sera (CC)
Assayed multicomponent serum calibrator, normal 41822 11 50 01 01 Assayed Multicomponent Sera (CC)
Assayed multicomponent serum control, normal 41823 11 50 01 01 Assayed Multicomponent Sera (CC)
Atrial natriuretic peptide calibrator 41824 12 50 01 07 Cardiac Marker Standards / Calibrators
Atrial natriuretic peptide control 41825 12 50 01 08 Cardiac Marker Controls
Beta-endorphin calibrator 41827 12 50 01 15 Individual and Specified Hormones Calibrators
Beta-endorphin control 41828 12 50 01 16 Individual and Specified Hormones Controls
Bilirubin calibrator 41830 11 50 03 02 Calibrators Single Component (CC)
Malachite green G 41832 14 01 08 02 Other Stains
Biochemical identification calibrator, anaerobe, automated 41833 14 50 01 90 Other Controls Microbiology
Biochemical identification control, anaerobe, automated control 41834 14 50 01 90 Other Controls Microbiology
C-peptide calibrator 41836 12 50 01 15 Individual and Specified Hormones Calibrators
C-peptide control 41837 12 50 01 16 Individual and Specified Hormones Controls
C-reactive protein calibrator 41838 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
C-reactive protein control 41839 12 50 01 14 Rheumatoid/Autoimmune Controls
Calcitonin calibrator 41840 12 50 01 15 Individual and Specified Hormones Calibrators
Calcitonin control 41841 12 50 01 16 Individual and Specified Hormones Controls
Calcium calibrator 41842 11 50 03 02 Calibrators Single Component (CC)
Calcium control 41843 11 50 02 04 Electrolyte Controls
Cellular enzyme determination calibrator 41846 13 01 20 90 Other Haematology Controls
Cellular enzyme determination control 41847 13 01 20 90 Other Haematology Controls
CENP-antibody calibrator 41848 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
CENP-antibody control 41849 12 50 01 14 Rheumatoid/Autoimmune Controls
Chromosome culture calibrator 41850 13 07 01 01 Chromosome Culture Kits / reagents
Chromosome culture control 41851 13 07 01 01 Chromosome Culture Kits / reagents
Circulating immune complex calibrator 41852 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Circulating immune complex control 41853 12 50 01 14 Rheumatoid/Autoimmune Controls
Citrate calibrator 41854 14 50 01 90 Other Controls Microbiology

Page 90 of 108
Citrate control 41855 14 50 01 90 Other Controls Microbiology

Collagen type I C-terminal propeptide calibrator 41856 12 50 01 15 Individual and Specified Hormones Calibrators
Collagen type I C-terminal propeptide control 41857 12 50 01 16 Individual and Specified Hormones Controls
Collagen type III C-terminal propeptide calibrator 41858 12 50 01 15 Individual and Specified Hormones Calibrators
Collagen type III C-terminal propeptide control 41859 12 50 01 16 Individual and Specified Hormones Controls
Complement component C3b activation control 41866 12 50 01 06 Specific Protein Controls
Reptilase kit 41867 13 02 01 03 Thrombin Time / Reptilase / Batroxobin Time
Batroxbin time kit 41868 13 02 01 03 Thrombin Time / Reptilase / Batroxobin Time
Thrombin time calibrator 41869 13 02 50 01 Calibration Plasmas
Thrombin time control 41870 13 02 50 02 Control Plasmas
Complement for HLA testing calibrator 41871 13 04 01 04 HLA Control Cells
Complement for HLA testing control 41872 13 04 01 04 HLA Control Cells
Coxiella calibrator 41879 15 50 01 01 Bacteriology Controls - Inf.Imm.
Coxiella control 41880 15 50 01 01 Bacteriology Controls - Inf.Imm.
Cross-linked C-telopeptide calibrator 41883 12 50 01 15 Individual and Specified Hormones Calibrators
Cross-linked C-telopeptide control 41884 12 50 01 16 Individual and Specified Hormones Controls
Cross-linked N-telopeptide calibrator 41885 12 50 01 15 Individual and Specified Hormones Calibrators
Cross-linked N-telopeptide control 41886 12 50 01 16 Individual and Specified Hormones Controls
Cryptosporidium control 41887 14 50 01 90 Other Controls Microbiology
Cyclic adenosine monophosphate calibrator 41888 12 50 01 15 Individual and Specified Hormones Calibrators
Cyclic adenosine monophosphate control 41889 12 50 01 16 Individual and Specified Hormones Controls
Dehydroepiandrosterone calibrator 41896 12 50 01 03 Hormone Standards / Calibrators
Dehydroepiandrosterone control 41897 12 50 01 04 Hormone Controls
Deoxypyridinoline calibrator 41898 12 50 01 15 Individual and Specified Hormones Calibrators
Deoxypyridinoline control 41899 12 50 01 16 Individual and Specified Hormones Controls
Distoma calibrator 41903 15 50 01 05 Parasitology Controls - Inf.Imm.
Distoma control 41904 15 50 01 05 Parasitology Controls - Inf.Imm.
Deoxyribonucleic acid in situ hybridization calibrator 41905 13 07 01 03 DNA in situ Hybridisation reagents
Deoxyribonucleic acid in situ hybridization control 41906 13 07 01 03 DNA in situ Hybridisation reagents
Anti-deoxyribonucleic acid antibody control 41907 12 50 01 14 Rheumatoid/Autoimmune Controls
Echinococcus calibrator 41908 15 50 01 05 Parasitology Controls - Inf.Imm.
Echinococcus control 41909 15 50 01 05 Parasitology Controls - Inf.Imm.
Enterovirus calibrator 41923 15 50 01 04 Other Virology Controls - Inf.Imm.
Enterovirus control 41924 15 50 01 04 Other Virology Controls - Inf.Imm.
Fatty acid binding protein (FABP) calibrator 41925 12 50 01 07 Cardiac Marker Standards / Calibrators
Fatty acid binding protein (FABP) control 41926 12 50 01 08 Cardiac Marker Controls
Ferritin calibrator 41927 12 50 01 11 Anaemia Related/Vitamin Standards and Calibrators
Ferritin control 41928 12 50 01 12 Anaemia Related/Vitamin Controls
Fibronectin calibrator 41929 12 50 01 05 Specific Protein Standards / Calibrators
Fibronectin control 41930 12 50 01 06 Specific Protein Controls

Page 91 of 108
Folate calibrator 41931 12 50 01 11 Anaemia Related/Vitamin Standards and Calibrators

Folate control 41932 12 50 01 12 Anaemia Related/Vitamin Controls
Glutamic acid decarboxylase II antibody/islet cell antibody calibrator 41933 12 50 01 15 Individual and Specified Hormones Calibrators
Glutamic acid decarboxylase II antibody/islet cell antibody control 41934 12 50 01 16 Individual and Specified Hormones Controls
GalNAc calibrator 41935 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
GalNAc control 41936 12 50 01 14 Rheumatoid/Autoimmune Controls
Gliadin antibody calibrator 41940 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Gliadin antibody control 41941 12 50 01 14 Rheumatoid/Autoimmune Controls
Glucagon calibrator 41942 12 50 01 15 Individual and Specified Hormones Calibrators
Glucagon control 41943 12 50 01 16 Individual and Specified Hormones Controls
Glycogen phosphorylase BB calibrator 41944 12 50 01 07 Cardiac Marker Standards / Calibrators
Glycogen phosphorylase BB control 41945 12 50 01 08 Cardiac Marker Controls
Gonococcus total antibody calibrator 41946 15 50 01 01 Bacteriology Controls - Inf.Imm.
Gonococcus total antibody control 41947 15 50 01 01 Bacteriology Controls - Inf.Imm.
Gonococcus antigen calibrator 41948 15 50 01 01 Bacteriology Controls - Inf.Imm.
Gonococcus antigen control 41949 15 50 01 01 Bacteriology Controls - Inf.Imm.
Gonococcus nucleic acid calibrator 41950 15 50 01 01 Bacteriology Controls - Inf.Imm.
Gonococcus nucleic acid control 41951 15 50 01 01 Bacteriology Controls - Inf.Imm.
Goodpasture antibody calibrator 41952 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Goodpasture antibody control 41953 12 50 01 14 Rheumatoid/Autoimmune Controls
Fixative, <specify> 41954 13 07 01 05 Fixing reagents (Histology/Cytology)
Blood diluting fluid 41955 13 01 01 01 CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)
Hepatitis A virus immunoglobulin G calibrator 41957 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis A virus immunoglobulin G control 41958 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis A virus immunoglobulin M calibrator 41959 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis A virus immunoglobulin M control 41960 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis A virus total antibody calibrator 41961 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis A virus total antibody control 41962 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis A virus antigen confirmatory calibrator 41964 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis A virus antigen confirmatory control 41965 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis C virus antibody confirmatory calibrator 41966 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis C virus antibody confirmatory control 41967 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis C virus immunoglobulin G calibrator 41968 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis C virus immunoglobulin G control 41969 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis C virus immunoglobulin M calibrator 41970 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis C virus immunoglobulin M control 41971 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis C virus total antibody calibrator 41972 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis C virus total antibody control 41973 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis C virus antigen calibrator 41974 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis C virus antigen control 41975 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.

Page 92 of 108
Hepatitis C virus nucleic acid calibrator 41979 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis C virus nucleic acid control 41980 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus core immunoglobulin M calibrator 41981 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus core immunoglobulin M control 41982 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus core total antibody calibrator 41983 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus core total antibody control 41984 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus core antigen calibrator 41985 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus core antigen control 41986 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus core antigen confirmatory calibrator 41987 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus core antigen confirmatory control 41988 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus core immunoglobulin G calibrator 41989 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus core immunoglobulin G control 41990 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus core nucleic acid calibrator 41991 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus core nucleic acid control 41992 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus surface immunoglobulin G calibrator 41993 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus surface immunoglobulin G control 41994 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus surface immunoglobulin M calibrator 41995 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus surface immunoglobulin M control 41996 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus surface total antibody calibrator 41997 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus surface total antibody control 41998 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus surface antigen calibrator 41999 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus surface antigen control 42000 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus e antibody immunoglobulin G calibrator 42001 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus e antibody immunoglobulin G control 42002 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus e antibody immunoglobulin M calibrator 42003 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus e antibody immunoglobulin M control 42004 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus e antigen total antibody calibrator 42005 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus e antigen total antibody control 42006 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus e antigen calibrator 42007 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus e antigen control 42008 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus e antigen nucleic acid calibrator 42009 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis B virus e antigen nucleic acid control 42010 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis D virus immunoglobulin G calibrator 42011 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis D virus immunoglobulin G control 42012 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis D virus total antibody calibrator 42013 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis D virus total antibody control 42014 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis D virus antigen calibrator 42015 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis D virus antigen control 42016 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis D virus nucleic acid calibrator 42017 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis D virus nucleic acid control 42018 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.

Page 93 of 108
Hepatitis E virus immunoglobulin G calibrator 42020 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.

Hepatitis E virus immunoglobulin G control 42021 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis E virus immunoglobulin M calibrator 42022 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis E virus immunoglobulin M control 42023 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis E virus total antibody calibrator 42024 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis E virus total antibody control 42025 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis E virus antigen calibrator 42026 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis E virus antigen control 42027 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis E virus nucleic acid calibrator 42028 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis E virus nucleic acid control 42029 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis G virus immunoglobulin G calibrator 42030 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis G virus immunoglobulin G control 42031 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis G virus immunoglobulin M calibrator 42032 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis G virus immunoglobulin M control 42033 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis G virus total antibody calibrator 42034 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis G virus total antibody control 42035 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis G virus antigen calibrator 42036 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis G virus antigen control 42037 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis G virus nucleic acid calibrator 42040 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Hepatitis G virus nucleic acid control 42041 15 50 01 02 Hepatitis Virus Controls - Inf.Imm.
Vitamin D calibrator, cholecalciferol 42052 12 50 01 11 Anaemia Related/Vitamin Standards and Calibrators
Vitamin D control, cholecalciferol 42053 12 50 01 12 Anaemia Related/Vitamin Controls
Vasopressin calibrator 42055 12 50 01 15 Individual and Specified Hormones Calibrators
Vasopressin control 42056 12 50 01 16 Individual and Specified Hormones Controls
Vasointestinal peptide calibrator 42058 12 50 01 15 Individual and Specified Hormones Calibrators
Vasointestinal peptide control 42059 12 50 01 16 Individual and Specified Hormones Controls
Uro/coproporphyrin calibrator 42061 11 50 03 02 Calibrators Single Component (CC)
Uro/coproporphyrin control 42062 11 50 02 90 Other Specific Control Sera (CC)
Urine sediment test calibrator 42064 11 50 90 02 Urine Control
Urine sediment test control 42065 11 50 90 02 Urine Control
U1-small nuclear ribonucleoprotein antibody calibrator 42073 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
U1-small nuclear ribonucleoprotein antibody control 42074 12 50 01 14 Rheumatoid/Autoimmune Controls
Tumour necrosis factor calibrator 42076 13 06 01 04 Tumour Necrosis Factors (TNFa,TNFb)
Tumour necrosis factor control 42077 13 06 01 04 Tumour Necrosis Factors (TNFa,TNFb)
Thyroid stimulating hormone receptor antibody calibrator 42079 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Thyroid stimulating hormone receptor antibody control 42080 12 50 01 14 Rheumatoid/Autoimmune Controls
Neonatal trypsin calibrator 42082 12 50 01 05 Specific Protein Standards / Calibrators
Neonatal trypsin control 42083 12 50 01 06 Specific Protein Controls
Transcobalamin S calibrator 42085 12 50 01 05 Specific Protein Standards / Calibrators
Transcobalamin S control 42086 12 50 01 06 Specific Protein Controls

Page 94 of 108
Histone calibrator 42087 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators

Histone control 42088 12 50 01 14 Rheumatoid/Autoimmune Controls
Human anti-mouse antibody calibrator 42089 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Human anti-mouse antibody control 42090 12 50 01 14 Rheumatoid/Autoimmune Controls
Insulin calibrator 42091 12 50 01 05 Specific Protein Standards / Calibrators
Insulin control 42092 12 50 01 06 Specific Protein Controls
Human T-cell leukaemia virus I antibody calibrator 42093 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human T-cell leukaemia virus I antibody control 42094 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human T-cell leukaemia virus I antigen calibrator 42095 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human T-cell leukaemia virus I antigen control 42096 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human T-cell leukaemia virus I nucleic acid calibrator 42097 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human T-cell leukaemia virus I nucleic acid control 42098 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human T-cell leukaemia virus II antibody calibrator 42099 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human T-cell leukaemia virus II antibody control 42100 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human T-cell leukaemia virus II antigen calibrator 42101 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human T-cell leukaemia virus II antigen control 42102 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human T-cell leukaemia virus II nucleic acid calibrator 42103 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human T-cell leukaemia virus II nucleic acid control 42104 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human T-cell leukaemia virus multiple antigen calibrator 42105 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human T-cell leukaemia virus multiple antigen control 42106 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human T-cell leukaemia virus multiple antibody calibrator 42107 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human T-cell leukaemia virus multiple antibody control 42108 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human T-cell leukaemia virus multiple antigen nucleic acid calibrator 42109 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human T-cell leukaemia virus multiple antigen nucleic acid control 42110 15 50 01 03 Retrovirus Controls - Inf.Imm.
Human leukocyte antigen antibody screening calibrator 42117 13 04 01 04 HLA Control Cells
Human leukocyte antigen antibody screening control 42118 13 04 01 04 HLA Control Cells
Human leukocyte antigen typing calibrator 42119 13 04 01 04 HLA Control Cells
Human leukocyte antigen typing control 42120 13 04 01 04 HLA Control Cells
Human leukocyte antigen control cells calibrator 42121 13 04 01 04 HLA Control Cells
Human leukocyte antigen control cells control 42122 13 04 01 04 HLA Control Cells
Human leukocyte antigen nucleic acid calibrator 42123 13 04 01 04 HLA Control Cells
Human leukocyte antigen nucleic acid control 42124 13 04 01 04 HLA Control Cells
Herpes simplex virus total antibody calibrator 42125 15 50 01 04 Other Virology Controls - Inf.Imm.
Herpes simplex virus total antibody control 42126 15 50 01 04 Other Virology Controls - Inf.Imm.
Herpes simplex virus calibrator 42127 15 50 01 04 Other Virology Controls - Inf.Imm.
Herpes simplex virus control 42128 15 50 01 04 Other Virology Controls - Inf.Imm.
Herpes simplex virus immunoglobulin G calibrator 42129 15 50 01 04 Other Virology Controls - Inf.Imm.
Herpes simplex virus immunoglobulin G control 42130 15 50 01 04 Other Virology Controls - Inf.Imm.
Herpes simplex virus immunoglobulin M calibrator 42131 15 50 01 04 Other Virology Controls - Inf.Imm.
Herpes simplex virus immunoglobulin M control 42132 15 50 01 04 Other Virology Controls - Inf.Imm.

Page 95 of 108
Herpes simplex virus nucleic acid calibrator 42133 15 50 01 04 Other Virology Controls - Inf.Imm.
Herpes simplex virus nucleic acid control 42134 15 50 01 04 Other Virology Controls - Inf.Imm.
Rubella virus nucleic acid calibrator 42135 15 50 01 04 Other Virology Controls - Inf.Imm.
Rubella virus nucleic acid control 42136 15 50 01 04 Other Virology Controls - Inf.Imm.
Rubella virus total antibody calibrator 42137 15 50 01 04 Other Virology Controls - Inf.Imm.
Rubella virus total antibody control 42138 15 50 01 04 Other Virology Controls - Inf.Imm.
Rubella virus immunoglobulin G calibrator 42139 15 50 01 04 Other Virology Controls - Inf.Imm.
Rubella virus immunoglobulin G control 42140 15 50 01 04 Other Virology Controls - Inf.Imm.
Rubella virus immunoglobulin M calibrator 42141 15 50 01 04 Other Virology Controls - Inf.Imm.
Rubella virus immunoglobulin M control 42142 15 50 01 04 Other Virology Controls - Inf.Imm.
Rotavirus calibrator 42143 15 50 01 04 Other Virology Controls - Inf.Imm.
Rotavirus control 42144 15 50 01 04 Other Virology Controls - Inf.Imm.
Leishmania calibrator 42145 15 50 01 05 Parasitology Controls - Inf.Imm.
Leishmania control 42146 15 50 01 05 Parasitology Controls - Inf.Imm.
Borrelia total antibody calibrator 42148 15 50 01 01 Bacteriology Controls - Inf.Imm.
Borrelia total antibody control 42149 15 50 01 01 Bacteriology Controls - Inf.Imm.
Borrelia antigen calibrator 42150 15 50 01 01 Bacteriology Controls - Inf.Imm.
Borrelia antigen control 42151 15 50 01 01 Bacteriology Controls - Inf.Imm.
Borrelia nucleic acid calibrator 42152 15 50 01 01 Bacteriology Controls - Inf.Imm.
Borrelia nucleic acid control 42153 15 50 01 01 Bacteriology Controls - Inf.Imm.
Legionella antibody calibrator 42154 15 50 01 01 Bacteriology Controls - Inf.Imm.
Legionella antibody control 42155 15 50 01 01 Bacteriology Controls - Inf.Imm.
Legionella antigen calibrator 42156 15 50 01 01 Bacteriology Controls - Inf.Imm.
Legionella antigen control 42157 15 50 01 01 Bacteriology Controls - Inf.Imm.
Legionella nucleic acid calibrator 42158 15 50 01 01 Bacteriology Controls - Inf.Imm.
Legionella nucleic acid control 42159 15 50 01 01 Bacteriology Controls - Inf.Imm.
Leptospira calibrator 42160 15 50 01 01 Bacteriology Controls - Inf.Imm.
Leptospira control 42161 15 50 01 01 Bacteriology Controls - Inf.Imm.
Toxoplasma immunoglobulin M calibrator 42163 15 50 01 05 Parasitology Controls - Inf.Imm.
Toxoplasma immunoglobulin M control 42164 15 50 01 05 Parasitology Controls - Inf.Imm.
Toxoplasma immunoglobulin G calibrator 42166 15 50 01 05 Parasitology Controls - Inf.Imm.
Toxoplasma immunoglobulin G control 42167 15 50 01 05 Parasitology Controls - Inf.Imm.
Toxoplasma total antibody calibrator 42169 15 50 01 05 Parasitology Controls - Inf.Imm.
Toxoplasma total antibody control 42170 15 50 01 05 Parasitology Controls - Inf.Imm.
Schistosoma calibrator 42171 15 50 01 05 Parasitology Controls - Inf.Imm.
Schistosoma control 42172 15 50 01 05 Parasitology Controls - Inf.Imm.
Salmonella antibody calibrator 42173 15 50 01 01 Bacteriology Controls - Inf.Imm.
Salmonella antibody control 42174 15 50 01 01 Bacteriology Controls - Inf.Imm.
Salmonella antigen calibrator 42175 15 50 01 01 Bacteriology Controls - Inf.Imm.
Salmonella antigen control 42176 15 50 01 01 Bacteriology Controls - Inf.Imm.

Page 96 of 108
Salmonella nucleic acid calibrator 42177 15 50 01 01 Bacteriology Controls - Inf.Imm.

Salmonella nucleic acid control 42178 15 50 01 01 Bacteriology Controls - Inf.Imm.
Rickettsia calibrator 42179 15 50 01 01 Bacteriology Controls - Inf.Imm.
Rickettsia control 42180 15 50 01 01 Bacteriology Controls - Inf.Imm.
Sex hormone binding globulin calibrator 42181 12 50 01 03 Hormone Standards / Calibrators
Sex hormone binding globulin control 42182 12 50 01 04 Hormone Controls
Hydroxyproline calibrator 42184 12 50 01 15 Individual and Specified Hormones Calibrators
Hydroxyproline control 42185 12 50 01 16 Individual and Specified Hormones Controls
Osteocalcine calibrator 42187 12 50 01 15 Individual and Specified Hormones Calibrators
Osteocalcine control 42188 12 50 01 16 Individual and Specified Hormones Controls
Pyridinoline calibrator 42189 12 50 01 15 Individual and Specified Hormones Calibrators
Pyridinoline control 42190 12 50 01 16 Individual and Specified Hormones Controls
Human growth hormone calibrator 42191 12 50 01 15 Individual and Specified Hormones Calibrators
Human growth hormone control 42192 12 50 01 16 Individual and Specified Hormones Controls
Insulin-like growth factor binding protein 1 calibrator 42193 12 50 01 15 Individual and Specified Hormones Calibrators
Insulin-like growth factor binding protein 1 control 42194 12 50 01 16 Individual and Specified Hormones Controls
Insulin-like growth factor I, somatomedin C calibrator 42196 12 50 01 15 Individual and Specified Hormones Calibrators
Insulin-like growth factor I, somatomedin C control 42197 12 50 01 16 Individual and Specified Hormones Controls
Neopterine calibrator 42198 12 50 01 15 Individual and Specified Hormones Calibrators
Neopterine control 42199 12 50 01 16 Individual and Specified Hormones Controls
Prostaglandin calibrator 42200 12 50 01 15 Individual and Specified Hormones Calibrators
Prostaglandin control 42201 12 50 01 16 Individual and Specified Hormones Controls
Pepsinogen calibrator 42202 12 50 01 15 Individual and Specified Hormones Calibrators
Pepsinogen control 42203 12 50 01 16 Individual and Specified Hormones Controls
Parathyroid hormone intact calibrator 42207 12 50 01 15 Individual and Specified Hormones Calibrators
Parathyroid hormone intact control 42208 12 50 01 16 Individual and Specified Hormones Controls
Parathyroid hormone-related peptide calibrator 42209 12 50 01 15 Individual and Specified Hormones Calibrators
Parathyroid hormone-related peptide control 42210 12 50 01 16 Individual and Specified Hormones Controls
Parathyroid hormone fragment calibrator 42211 12 50 01 15 Individual and Specified Hormones Calibrators
Parathyroid hormone fragment control 42212 12 50 01 16 Individual and Specified Hormones Controls
Polymyositis-scleroderma antibody calibrator 42213 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Polymyositis-scleroderma antibody control 42214 12 50 01 14 Rheumatoid/Autoimmune Controls
Retinol binding protein calibrator 42217 12 50 01 05 Specific Protein Standards / Calibrators
Retinol binding protein control 42218 12 50 01 06 Specific Protein Controls
Parietal cell antibody calibrator 42219 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Parietal cell antibody control 42220 12 50 01 14 Rheumatoid/Autoimmune Controls
Sperm antibody calibrator 42221 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Sperm antibody control 42222 12 50 01 14 Rheumatoid/Autoimmune Controls
Systemic lupus erythematosis calibrator 42224 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Systemic lupus erythematosis control 42225 12 50 01 14 Rheumatoid/Autoimmune Controls

Page 97 of 108
Scleroderma-70 antibody calibrator 42226 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators

Scleroderma-70 antibody control 42227 12 50 01 14 Rheumatoid/Autoimmune Controls
Oxytocin calibrator 42228 12 50 01 15 Individual and Specified Hormones Calibrators
Oxytocin control 42229 12 50 01 16 Individual and Specified Hormones Controls
Rheumatoid factor calibrator 42230 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Rheumatoid factor control 42231 12 50 01 14 Rheumatoid/Autoimmune Controls
Reticulocyte calibrator 42232 13 01 20 06 Reticulocyte Control
Rhesus phenotype calibrator 42233 13 03 20 02 Control Kits (Immunohaematology)
Rhesus phenotype control 42234 13 03 20 02 Control Kits (Immunohaematology)
Monospecific antihuman serum calibrator 42235 13 03 20 02 Control Kits (Immunohaematology)
Monospecific antihuman serum control 42236 13 03 20 02 Control Kits (Immunohaematology)
Mycobacterium susceptibility test calibrator 42242 14 50 01 Controls/Standards/Calibrators - Microbiology
Mycobacterium susceptibility test control 42243 14 50 01 Controls/Standards/Calibrators - Microbiology
Respiratory syncytial virus calibrator 42247 15 50 01 04 Other Virology Controls - Inf.Imm.
Respiratory syncytial virus control 42248 15 50 01 04 Other Virology Controls - Inf.Imm.
Myeloperoxidase antineutrophil cytoplasmic autoantibody calibrator 42249 12 50 01 13 Rheumatoid/Autoimmune Standards / Calibrators
Myeloperoxidase antineutrophil cytoplasmic autoantibody control 42250 12 50 01 14 Rheumatoid/Autoimmune Controls
Incubator, laboratory, <specify> 42358 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Clinical chemistry analyser, automated, continuous-flow 42362 21 01 10 01 CH Hardware + dedicated accessories + software
Counter, colony 42363 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Creatinine analyser 42364 21 01 10 01 CH Hardware + dedicated accessories + software
Fertility analyser, thermometric 42367 21 02 10 01 IC Hardware + dedicated accessories + software
Hydrogen gas analyser 42370 00 00 00 00 Not for IVD use
Nephelometric immunoassay analyser 42371 21 02 10 01 IC Hardware + dedicated accessories + software
Carbon dioxide monitor, laboratory incubator 42429 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Tissue flotation bath 42437 00 00 00 00 Not for IVD use
Blood bank centrifuge 42460 28 01 10 01 SP Hardware + accessories + software
Cell washing centrifuge 42461 28 01 10 01 SP Hardware + accessories + software
Uric acid electrode 42544 11 04 03 90 Other Substrate - Electrodes / Biosensors
Endoscopic light source 42572 00 00 00 00 Not for IVD use
Thymol 42621 11 02 01 27 Thymol
Fecal Occult Blood -Rapid Test 42649 11 70 03 01 Faecal Occult Blood (CC) IC =>12.03.90.04
Sm 42669 12 10 01 11 Sm
Meningitis causative agent 42718 15 04 80 90 Other Viral Antigen/Antibody Detection
Hemoglobinometer 42753 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Analyser, blood grouping 42755 23 03 10 01 BG Hardware + dedicated accessories + software
Sample processor 42761 28 01 10 01 SP Hardware + accessories + software
Clinical chemistry sample processor 42762 28 01 10 01 SP Hardware + accessories + software
Haematology sample processor 42763 28 01 10 01 SP Hardware + accessories + software
Microbiology sample processor 42764 28 01 10 01 SP Hardware + accessories + software

Page 98 of 108
Mean corpuscular haemoglobin concentration kit 42817 13 01 01 01 CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)

Aluminium kit 42818 11 03 01 90 Other Electrolytes
Fluorimetric immunoassay analyser 42819 21 02 10 01 IC Hardware + dedicated accessories + software
Type I procollagen-C-propeptide kit 42822 12 06 03 03 Collagen Type I C-terminal Propeptide
CLIA (ChemiLuminescent Immunoassay Analyser) 42823 21 02 10 01 IC Hardware + dedicated accessories + software
Sialyl Lex antigen kit 42825 12 03 01 90 Other Cancer Antigens
Pipette shield 42827 00 00 00 00 Not for IVD use
Blender, clinical laboratory 42828 00 00 00 00 Not for IVD use
Separator, plasma 42832 28 01 10 01 SP Hardware + accessories + software
Counter, cell, differential 42835 23 01 10 01 CC Hardware + dedicated accessories + software
Analyser, point-of-care, breath, methane 42836 00 00 00 00 Not for IVD use
Laboratory equipment, agitator 42837 00 00 00 00 Not for IVD use
Analyser operating system software 42838 41 01 01 01 Diagnostics & Clinical Interpretation Supporting Software
Escherichia coli vero toxin kit 42846 15 01 15 01 E. Coli Direct Antigen Detection
Urea nitrogen kit, unrinalysis 42849 11 02 01 04 Urea/Blood Urea Nitrogen
Proinsulin kit 42852 12 06 01 08 Proinsulin
Heart fatty acid binding protein kit 42860 12 13 01 03 Fatty Acid Binding Protein
Gastrin kit 42862 12 06 90 01 Gastrin
Acid phosphatase isoenzyme activity kit 42864 11 01 01 02 Acid Phosphatase (CC) IC => 12.03.01.37
Glycoholic acid kit 42868 11 02 01 02 Bile acids
Monoamine oxidase kit 42870 12 08 02 90 Other Central Nervous System TDM
Laboratory equipment, petri dish filler 42872 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Software, operating system, analyser 42873 41 01 01 01 Diagnostics & Clinical Interpretation Supporting Software
Pipette, micro 42875 00 00 00 00 Not for IVD use
Selenium kit 42876 11 03 01 90 Other Electrolytes
Intrinsic coagulation factor kit 42889 12 07 02 10 Intrinsic Factor (blocking Antibody)
2-5A synthetase kit 42890 00 00 00 00 Not for IVD use
Bacteria counter 42897 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Anti-SS-B/La antibody kit 42899 12 10 01 13 SS-B
Aspartate aminotransferase isoenzyme activity kit 42901 11 01 01 10 Aspartate Amino-Transferase
Lactate dehydrogenase isoenzyme activity kit 42907 11 01 01 21 Lactate Dehydrogenase Isoenzymes
Isepamicin kit 42920 12 08 03 90 Other Antibiotics TDM
Haloperidol kit 42921 12 08 02 90 Other Central Nervous System TDM
Aprinidine kit 42925 12 08 03 90 Other Antibiotics TDM
West Nile virus kit 42926 15 04 80 90 Other Viral Antigen/Antibody Detection
Zonisamide kit 42928 12 08 03 90 Other Antibiotics TDM
Arbekacin kit 42929 12 08 03 90 Other Antibiotics TDM
Cobalt kit 42930 11 02 01 90 Other Substrates
Bromperidol kit 42931 12 09 01 90 Other drugs of abuse
Culture medium, antimicrobial susceptibility test, dilution method 42935 14 02 05 01 MIC Systems - Manual

Page 99 of 108
Type I collagen-C-telopeptide kit 42941 12 06 03 03 Collagen Type I C-terminal Propeptide

Endotoxin kit 42947 14 02 03 01 Serotyping (E.coli, Salmonella, Shigella, etc.)
Stirrer 42952 00 00 00 00 Not for IVD use
Vibrio parahaemolyticus serotyping kit 42957 14 02 03 01 Serotyping (E.coli, Salmonella, Shigella, etc.)
Apolipoprotein E kit 42978 12 01 04 11 Apolipoprotein E Genotyping Sub-typing GT=>16 01 02 03 00
APR score kit 42986 12 30 01 90 Other Multiple Immunochemistry Reagents
Cholesteryl ester transfer protein kit 42993 12 01 03 90 Other Transport Proteins
SV5 virus antibody kit 42994 15 04 80 90 Other Viral Antigen/Antibody Detection
Lipid peroxide kit 42998 12 01 04 90 Other Lipoproteins
SV5 virus kit 43009 15 04 80 90 Other Viral Antigen/Antibody Detection
1,5-Anhydroglucitol kit 43010 12 06 01 90 Other Diabetes tests
Pipette, sahli 43023 00 00 00 00 Not for IVD use
Pipette, diluting 43024 00 00 00 00 Not for IVD use
Pipette, quantitative, hematology 43029 00 00 00 00 Not for IVD use
Pipette, pasteur 43033 00 00 00 00 Not for IVD use
Cancer antigen 602 kit 43034 12 03 01 90 Other Cancer Antigens
Separator, automated, blood cell 43037 28 01 10 01 SP Hardware + accessories + software
Factor Xa inhibitor kit 43046 13 02 06 06 Coagulation factor X Inhibitor
B cell kit 43047 13 05 01 01 Antibodies for B and T-cell subtyping
Tau protein kit, cerebrospinal fluid 43049 12 01 90 90 Other Other Plasma Proteins
Leukocyte kit 43052 13 01 01 01 CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)
Monocyte kit 43055 13 01 01 01 CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)
Amniotic fluid pH kit 43056 11 90 01 90 Other, Other Clinical Chemistry Reagents
Thymocyte kit 43059 13 05 01 01 Antibodies for B and T-cell subtyping
Natural killer cell kit 43062 13 06 01 90 Other Lymphokines /Immunmodulators
Basophil count kit 43065 13 01 01 01 CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)
Granulocyte kit 43068 13 01 01 01 CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)
Electrode, glycated haemoglobin 43069 11 04 03 03 Glycated Haemoglobin - Electrodes
Hepatocyte growth factor kit 43072 12 03 90 90 Other Other Tumour Markers
Tissue plasminogen activator-plasminogen activator inhibitor-1 43073 13 02 05 07 Tissue Plasminogen Activator
Anti-acetylcholine receptor antibody kit 43074 12 10 90 23 Acetylcholin Receptor Antibodies
Anti-cardiolipin beta-2-glycoprotein I complex antibody kit 43075 12 10 90 01 Anti-Cardiolipin Antibodies
Sodium chloride kit, urinary 43078 11 70 02 90 Other Urine Testing
T cell kit 43079 13 05 01 01 Antibodies for B and T-cell subtyping
Eosinophil count kit 43080 13 01 01 01 CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)
Pan T cell kit 43083 13 05 01 01 Antibodies for B and T-cell subtyping
Delta-aminolevulinic acid kit, urinary 43085 11 02 01 09 Delta-Aminolaevulinic acid
Saliva occult blood kit 43087 12 03 90 04 Fecal Occult Blood (IC) CC =>11.70.03.01
Leukocyte count kit 43091 13 01 01 01 CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)
CALLA-expressing cell kit 43092 12 03 01 90 Other Cancer Antigens

Page 100 of 108
Erythrocyte count kit 43095 13 01 01 01 CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)

LeY-expressing lymphocyte kit 43096 12 03 90 90 Other Other Tumour Markers
Mean corpuscular haemoglobin kit 43097 13 01 01 01 CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)
T cell subset kit 43098 13 05 01 01 Antibodies for B and T-cell subtyping
Ammonia kit, urinary 43101 11 03 01 01 Ammonia
Uropepsin kit, urinary 43103 11 01 01 27 Pepsin
Anti-platelet antibody kit 43105 12 10 90 90 Other Other Auto-Immune Disease Tests
Anti-mitochondrial antibody M2 kit 43106 12 10 90 02 Anti-Mitochondrial Antibodies
A-/B-transferase kit 43108 13 03 01 90 Other ABO Typing Tests
Catalase kit, urinary 43109 11 01 01 90 Other Enzymes
Indirect antiglobulin test kit 43111 13 03 20 01 Coombs Control Cells
Globulin kit, cerebrospinal fluid 43112 11 02 01 30 Total Protein
Irregular antibody kit 43113 00 00 00 00 Not for IVD use
Urine specific gravity kit 43117 11 70 02 90 Other Urine Testing
Anti-glomerular basement membrane antibody kit 43128 12 10 90 15 Antibodies to Glomerular Basal Membrane
B cell subset kit 43129 13 05 01 01 Antibodies for B and T-cell subtyping
Prostate specific antigen/alpha-1-antichymotrypsin complex kit 43145 12 03 01 32 Total Prostatic Specific Antigen
Estrone-3-glucuronide self-test kit 43148 12 70 05 90 Other Fertility/Pregnancy Rapid Tests
Homovanillic acid kit 43149 12 09 02 18 Homovanillic Acid
Pulmonary adenocarcinoma antigen 130 kit 43150 12 03 01 90 Other Cancer Antigens
Dehydroepiandrosterone-sulfate kit 43159 12 05 01 02 Dehydro-epiandrosterone Sulphate (incl. DHEA)
Culture identification kit, fungal 43162 14 03 04 02 Identification Systems for Fungi - Manual
Clostridium perfringens type A kit, heat-resistant 43175 15 01 90 90 Other Other Bacteriology Immunoassays
Software, application program, analyser 43187 41 01 01 01 Diagnostics & Clinical Interpretation Supporting Software
Semen analysis system 43189 21 02 10 01 IC Hardware + dedicated accessories + software
Alkalescens-Dispar identification kit 43193 14 02 03 01 Serotyping (E.coli, Salmonella, Shigella, etc.)
Surfactant protein D kit 43194 12 01 04 90 Other Lipoproteins
Galactose transferase kit 43195 11 01 01 90 Other Enzymes
Cancer antigen 54/61 kit 43196 12 03 01 90 Other Cancer Antigens
Nuclear matrix protein 22 kit 43197 12 03 90 90 Other Other Tumour Markers
Glycosylated haemoglobin kit 43198 12 06 01 06 Glycosylated/Glycated Haemoglobin CC=11.02.01.14
p-Aminobenzoic acid kit 43199 00 00 00 00 Not for IVD use
Phospholipase A2 kit 43200 11 01 01 90 Other Enzymes
Adenosine deaminase kit 43201 11 01 01 90 Other Enzymes
Thymol turbidity test kit 43203 11 02 01 27 Thymol
Zinc sulfate turbidity test kit 43204 11 02 01 33 Zinc
Buret 43211 00 00 00 00 Not for IVD use
Microtome, ultra 43212 23 05 10 01 HC Hardware + dedicated accessories + software
Rotary microtome 43213 23 05 10 01 HC Hardware + dedicated accessories + software
Cryostat microtome 43214 23 05 10 01 HC Hardware + dedicated accessories + software

Page 101 of 108
Laboratory oven, paraffin 43215 00 00 00 00 Not for IVD use

Paraffin dispenser 43217 00 00 00 00 Not for IVD use
Chondrocalcin kit 43224 12 11 01 90 Other Rheumatoid Factors
(1-3)-beta-D-glucan kit 43226 15 06 01 90 Other Mycology Immunoassays
Influenza virus A/B neuraminidase kit 43228 15 04 80 04 Influenza & Para Influenza
Elastase I kit 43237 12 01 90 06 Trypsin-a1-Antitrypsin (Elastase)
Antibiotic susceptibility testing kit, fungal 43242 14 03 06 01 Susceptibility Testing Systems for Yeasts and Fungi
Rickettsia tsutsugamushi antigen kit 43250 15 01 90 05 Rickettsia
Hepatitis B virus DNA polymerase kit 43251 15 02 02 40 Hepatitis B Virus - NA Reagents
Pump, laboratory, high-pressure liquid chromatography 43252 00 00 00 00 Not for IVD use
Complement CH50 kit 43254 12 01 02 11 Total Complement Activity ( CH50 )
Tissue culture bottle 43255 23 05 30 01 HC Consumables
Vacuum culture bottle 43258 24 09 30 01 Other_MCB Consumables
Cortisol kit, serum 43259 12 06 02 04 Cortisol
Ovens, paraffin 43260 00 00 00 00 Not for IVD use
Molybdenum kit 43263 11 03 01 90 Other Electrolytes
Protein fraction kit 43264 11 02 01 35 Protein Electrophoresis
Oven, laboratory, paraffin 43269 00 00 00 00 Not for IVD use
ErbB-2 kit 43270 12 03 03 90 Other Oncoproteins
Cadmium kit 43273 11 03 01 90 Other Electrolytes
Conjugated bilirubin kit 43274 11 02 01 03 Bilirubin
Manganese kit 43275 11 02 01 90 Other Substrates
Blood glucose analyser 43278 21 01 10 01 CH Hardware + dedicated accessories + software
Phosphoenol pyruvate, ADP, NADH, pyruvate kinase 43290 11 02 01 26 Pyruvate
Hyaluronic acid kit 43294 12 11 01 02 Anti-Streptococcal Hyaluronidase
Lecithin-cholesterol acyltransferase kit 43296 11 02 01 19 Lecithin
Thyroxine binding capacity kit 43297 12 04 01 09 Thyroid binding globulin
Type I collagen cross-linked N-telopeptide kit 43299 12 06 03 03 Collagen Type I C-terminal Propeptide
Micro pipette 43300 00 00 00 00 Not for IVD use
Blender/mixer 43302 00 00 00 00 Not for IVD use
Shaker/stirrer 43303 00 00 00 00 Not for IVD use
Factor VIII-associated antigen kit 43305 13 02 02 07 Coagulation factor VIII
Sialyl Tn antigen kit 43306 12 03 01 90 Other Cancer Antigens
NCC-ST-439 antigen kit 43307 12 03 01 90 Other Cancer Antigens
DUPAN-2 antigen kit 43308 12 03 01 90 Other Cancer Antigens
Human tumour associated carbohydrate antigen kit 43309 12 03 01 90 Other Cancer Antigens
Mean corpuscular volume kit 43321 00 00 00 00 Not for IVD use
Cylinder, liquid nitrogen 43324 00 00 00 00 Not for IVD use
Formulations, paraffin, all 43325 00 00 00 00 Not for IVD use
Sliding microtome 43331 23 05 10 01 HC Hardware + dedicated accessories + software

Page 102 of 108
Bottle, roller, tissue culture 43345 23 05 10 01 HC Hardware + dedicated accessories + software

Periodontopathic peptidase kit 43349 15 01 90 90 Other Other Bacteriology Immunoassays
Pancreatic secretory trypsin inhibitor kit 43350 12 01 90 90 Other Other Plasma Proteins
1 to 3-beta-D-glucan kit 43352 15 06 01 90 Other Mycology Immunoassays
Haemophilus capsular typing kit 43353 15 01 90 10 Haemophilus influenzae
Yersinia pseudotuberculosis kit, colony-specific 43354 15 01 90 06 Yersinia
Fibrin/fibrinogen degradation product/fraction E kit 43361 13 02 05 02 Fibrinogen Degradation Products
Type IV collagen kit 43373 12 06 03 90 Other Bone Metabolism Tests
Sample concentrator 43374 28 01 10 01 SP Hardware + accessories + software
Pipette, manual-induction 43375 00 00 00 00 Not for IVD use
Creatine kit 43378 11 02 01 07 Creatinine
Super oxide dismutase kit 43379 11 01 01 90 Other Enzymes
Aluminum kit 43383 11 03 01 90 Other Electrolytes
Porphobilinogen kit, urinalysis 43393 11 02 01 25 Porphobilinogen
Albumin/globulin ratio kit 43394 12 01 03 90 Other Transport Proteins
Culture media bottle 43398 14 01 03 Prepared Media in Bottles (Bacteriology)
Detector, electrochemical, liquid chromatography 43401 21 05 10 02 HPLC Hardware + dedicated accessories + software
Terminal deoxynucleotidyl transferase kit 43412 12 03 90 90 Other Other Tumour Markers
Oven, microwave, plasma-thawing 43418 00 00 00 00 Not for IVD use
Eosinophil basic protein kit 43419 12 01 90 90 Other Other Plasma Proteins
Soluble fibrin monomer complex kit 43421 13 02 03 03 Fibrin sensitivity monomer
Anti-SS-A/Ro antibody kit 43427 12 10 01 12 SS-A
Gamma-seminoprotein kit 43428 12 03 01 90 Other Cancer Antigens
Plasma thawing unit 43434 00 00 00 00 Not for IVD use
Container, frozen donor tissue storage 43436 23 05 30 01 HC Consumables
Active renin kit 43439 12 06 02 05 Renine (Plasma Renine Activity)
BUN analyser 43440 21 01 10 01 CH Hardware + dedicated accessories + software
Laboratory equipment, mixer 43442 00 00 00 00 Not for IVD use
Estriol-16-alpha-glucuronide kit 43443 12 05 02 90 Other Pregnancy Testing Hormones
Renin kit 43444 12 06 02 05 Renine (Plasma Renine Activity)
HIV structural protein-specific antibody kit 43454 15 03 01 07 HIV 1 Antibody - Confirmatory
Beta-human chorionic gonadotropin core kit 43456 12 05 02 06 ß Human Chorionic Gonadotropin (incl. subunit)
Histamine kit 43457 12 02 01 90 Other Allergy Tests
Separator for therapeutic purposes, membrane automated blood 43458 28 01 10 01 SP Hardware + accessories + software
Sialylated carbohydrate antigen KL-6 kit 43462 12 03 01 90 Other Cancer Antigens
Analyser application program software 43472 41 01 01 01 Diagnostics & Clinical Interpretation Supporting Software
Pharmacy balance 43473 00 00 00 00 Not for IVD use
Cystine aminopeptidase kit 43475 12 06 90 90 Other Individual and Specified Hormones
AIDS-associated virus antibody kit 43477 15 03 20 04 HIV Multiple Antibody
AFP-L3 fraction ratio kit 43480 12 03 90 01 Alphafetoprotein

Page 103 of 108
Agitator, ultrasonic, for drug dissolution 43484 00 00 00 00 Not for IVD use
Electrolyte analyser, ion-selective 43636 21 04 10 01 GE Hardware + dedicated accessories + software
Chemiluminescence immunoassay Analyser 43639 21 02 10 01 IC Hardware + dedicated accessories + software
Haematocrit centrifuge 43648 23 09 10 01 Other_HHC Hardware + dedicated accessories + software
Bacteriological incubator 43656 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Laboratory equipment, freezer dryer 43812 00 00 00 00 Not for IVD use
Complement component C3 proactivator kit 43815 12 01 02 03 Complement Component C3/C3c
Shield, pipette 43819 00 00 00 00 Not for IVD use
Laboratory balance 43822 00 00 00 00 Not for IVD use
SPan-1 antigen kit 43823 12 03 01 90 Other Cancer Antigens
Sialyl Lex-i antigen kit 43824 12 03 01 90 Other Cancer Antigens
BCA 225 kit 43825 12 03 01 90 Other Cancer Antigens
Cryobiological storage container 43832 23 05 30 01 HC Consumables
Laboratory equipment, blood plasma thawing unit 43844 00 00 00 00 Not for IVD use
Mixer, laboratory 43845 00 00 00 00 Not for IVD use
Laboratory equipment, staining apparatus 43846 23 05 10 01 HC Hardware + dedicated accessories + software
Laboratory equipment, blood separator 43847 28 01 10 01 SP Hardware + accessories + software
Laboratory equipment, tissue preparation machine 43848 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Laboratory equipment, DNA thermal cycler 43849 26 01 10 01 NA Hardware + dedicated accessories + software
Gel dryer, laboratory 43850 00 00 00 00 Not for IVD use
Laboratory equipment, evaporation apparatus 43852 00 00 00 00 Not for IVD use
Freezer/dryer, laboratory 43853 00 00 00 00 Not for IVD use
Electrophoresis analyser 43854 21 05 10 01 EP Hardware + dedicated accessories + software
Jaundice meter 43856 00 00 00 00 Not for IVD use
Laboratory equipment, shaker 43860 00 00 00 00 Not for IVD use
Laboratory equipment, serum separator 43893 28 01 10 01 SP Hardware + accessories + software
Sample tube vacutip inserting device 43895 28 01 10 01 SP Hardware + accessories + software
Analyser pump, high-pressure liquid chromatography 43898 21 05 10 02 HPLC Hardware + dedicated accessories + software
Analyser injector, high-pressure liquid chromatography 43899 21 05 10 02 HPLC Hardware + dedicated accessories + software
Analyser detector, high-pressure liquid chromatography 43900 21 05 10 02 HPLC Hardware + dedicated accessories + software
Laboratory equipment, sample alternator 43901 28 01 10 01 SP Hardware + accessories + software
Enzyme immunoassay analyser 43902 21 02 10 01 IC Hardware + dedicated accessories + software
Laboratory equipment, cell splitter 43903 28 01 10 01 SP Hardware + accessories + software
Analyser detector, gas chromatography 43905 00 00 00 00 Not for IVD use
Lab-equipment, cooling tank nitrogen 43913 00 00 00 00 Not for IVD use
Laboratory equipment, sample processor 43914 28 01 10 01 SP Hardware + accessories + software
Petri dish processor 43921 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Agitator 43938 00 00 00 00 Not for IVD use
Laboratory equipment, cell separator 43942 28 01 10 01 SP Hardware + accessories + software
SV41 virus kit 43955 15 04 80 90 Other Viral Antigen/Antibody Detection

Page 104 of 108
Vial, challenge, endotoxin 43957 24 09 30 01 Other_MCB Consumables

Dryer, gel, laboratory 43964 00 00 00 00 Not for IVD use
Pipette, mechanical 43982 00 00 00 00 Not for IVD use
Varicella-zoster virus immunoglobulin G kit 44016 15 04 80 10 Varicella Zoster
Papillomavirus nucleic acid kit 44017 15 04 40 03 Human Papilloma Virus - NA Reagents
Endotoxin control 44018 14 50 01 90 Other Controls Microbiology
Measles virus immunoglobulin G kit 44019 15 04 80 07 Measles
Mycobacterium leprae specific antibody kit 44020 15 01 07 03 Mycobacterial Antibody Assays
Bordetella antibody kit 44021 15 01 90 07 Bordetella pertussis / parapertussis
Reovirus antibody kit 44022 15 04 80 90 Other Viral Antigen/Antibody Detection
Escherichia coli 0157 antigen kit 44023 15 01 15 01 E. Coli Direct Antigen Detection
Group A streptococcal polysaccharide kit 44024 15 01 11 01 Streptococcal Direct Antigen Detection
Rotavirus antibody kit 44026 15 04 80 06 Rotavirus
Varicella-zoster virus immunoglobulin M kit 44027 15 04 80 10 Varicella Zoster
Salmonella typhi antibody kit 44028 15 01 10 03 Salmonella Antibody Assays
Group B streptococcus antigen kit 44029 15 01 11 01 Streptococcal Direct Antigen Detection
Escherichia coli H7 antigen kit 44030 15 01 15 01 E. Coli Direct Antigen Detection
Group A beta-hemolytic streptococcus antigen kit 44031 15 01 11 01 Streptococcal Direct Antigen Detection
West Nile virus calibrator 44038 15 50 01 04 Other Virology Controls - Inf.Imm.
West Nile virus nucleic acid kit 44048 15 04 40 90 Other Virology - NA Reagents
West Nile virus control 44049 15 50 01 04 Other Virology Controls - Inf.Imm.
Information system application program software, clinical laboratory 44082 41 01 01 01 Diagnostics & Clinical Interpretation Supporting Software
Software, clinical laboratory information system 44115 41 01 01 01 Diagnostics & Clinical Interpretation Supporting Software
FIA (Fluorescent Immunoassay Analyser) 44146 21 02 10 01 IC Hardware + dedicated accessories + software
EIA (Enzyme Immunoassay Analyser) 44147 21 02 10 01 IC Hardware + dedicated accessories + software
Glycated albumin kit 44153 11 02 01 14 Glycosylated/Glycated Haemoglobin IC=12.06.01.06
Mucoprotein kit 44154 11 02 01 90 Other Substrates
Beta-closslap kit 44155 00 00 00 00 Not for IVD use
Haematological separator, <specify> 44164 28 01 10 01 SP Hardware + accessories + software
Remnant lipoprotein kit 44169 12 01 04 90 Other Lipoproteins
Lipoprotein fraction kit 44170 12 01 04 90 Other Lipoproteins
Guanase kit 44171 11 01 01 90 Other Enzymes
Acid fast bacteria nucleic acid identification kit 44172 14 02 06 Nucleic Acid Identification (Bacteriology)
Amino acid fractionation kit 44174 12 06 90 90 Other Individual and Specified Hormones
Amino acid fractionation kit, urinary 44175 12 06 90 90 Other Individual and Specified Hormones
Branched-chain amino acid/tyrosine molar ratio kit 44176 12 06 90 90 Other Individual and Specified Hormones
p-Aminohippuric acid kit 44177 00 00 00 00 Not for IVD use
Nonprotein nitrogen kit 44178 11 02 01 04 Urea/Blood Urea Nitrogen
Polyamine kit 44179 11 02 01 90 Other Substrates
Methionine kit 44180 12 06 90 90 Other Individual and Specified Hormones

Page 105 of 108
Pheylalanine kit 44181 12 06 90 90 Other Individual and Specified Hormones

Meningitis-causing bacteria capsular polysaccharide antigen kit 44198 15 04 80 90 Other Viral Antigen/Antibody Detection
Hepatitis antigen-albumin receptor complex 44199 15 02 02 90 Other Hepatitis B Reagents
Hepatitis B virus pre-S2 antigen kit 44200 15 02 02 90 Other Hepatitis B Reagents
Anti-Mycobacterium antibody kit 44201 12 10 90 90 Other Other Auto-Immune Disease Tests
Anti-Anisakis immunoglobulin G/immunoglobulin A kit 44202 12 10 90 90 Other Other Auto-Immune Disease Tests
Vibrio parahaemolyticus thermostable direct hemolysin kit 44203 14 02 03 01 Serotyping (E.coli, Salmonella, Shigella, etc.)
Helicobacter pylori urease kit 44204 15 70 01 02 H. Pylori - Rapid Test
Chloridometer 44206 21 04 10 01 GE Hardware + dedicated accessories + software
Methane breath analyser 44210 00 00 00 00 Not for IVD use
Histamine release test kit 44211 12 02 01 90 Other Allergy Tests
Automated blood cell and plasma separator for therapeutic purposes, 44217 28 01 10 01 SP Hardware + accessories + software
Meter, jaundice 44219 00 00 00 00 Not for IVD use
2,3-Diphosphoglycerate kit 44228 13 03 01 90 Other ABO Typing Tests
Prolyl hydroxylase kit 44229 11 01 01 90 Other Enzymes
Unsaturated iron binding capacity kit 44236 12 07 01 05 Iron Binding Capacity - Total (IC) CC =>11.02.01.17
Gastric occult blood kit 44238 12 03 90 04 Fecal Occult Blood (IC) CC =>11.70.03.01
Secretin kit 44239 12 06 90 90 Other Individual and Specified Hormones
Blood specific gravity kit 44250 13 01 09 90 Other Other Haematology Testing Reagents
Separator, semi-automated, blood component 44252 28 01 10 01 SP Hardware + accessories + software
Kit, test, quality control for endotoxin 44253 14 02 03 01 Serotyping (E.coli, Salmonella, Shigella, etc.)
Deoxythymidine kinase kit 44254 12 03 90 12 Thymidine Kinase
Erythrocyte diameter kit 44257 13 01 01 01 CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)
Irradiator, blood, extracorporeal 44259 00 00 00 00 Not for IVD use
Assay, endotoxin activity, chemiluminescent 44275 14 02 03 01 Serotyping (E.coli, Salmonella, Shigella, etc.)
Elisa, antibody, west nile virus 44281 15 04 80 90 Other Viral Antigen/Antibody Detection
Alcohol breath analyser 44289 00 00 00 00 Not for IVD use
Detector, gas chromatography 44290 00 00 00 00 Not for IVD use
Platelet aggregation Analyser 44291 23 02 10 01 HS Hardware + dedicated accessories + software
Hepatitis C virus core protein kit 44292 15 02 03 04 HCV Antibody (Total)
Type IV collagen 7S kit 44293 12 06 03 90 Other Bone Metabolism Tests
Anti-ENA antibody kit 44300 12 10 01 02 ENA Screening
Anti-centromere antibody kit 44308 12 10 01 15 Anti-centromere Antibodies
Differential leukocyte count kit 44309 13 01 01 01 CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)
Immunoglobulin G rheumatoid factor kit 44310 12 11 01 10 Rheumatoid Factors
Cell separator 44311 00 00 00 00 Not for IVD use
Serum separator 44316 28 01 10 01 SP Hardware + accessories + software
Ornithine carbamoly transferase kit 44317 11 01 01 90 Other Enzymes
Japanese encephalitis virus antibody kit 44321 15 04 80 90 Other Viral Antigen/Antibody Detection
Hepatitis C virus core antibody kit 44324 15 02 03 04 HCV Antibody (Total)

Page 106 of 108
Pregnancy specific protein-1 kit 44325 12 05 02 08 Pregnancy Specific B1 -glycoprotein

Arginine vasopressin kit 44329 12 06 04 08 Vasopressin
D-arabinitol kit 44342 15 06 01 02 Candida albicans
Sorbitol kit 44343 11 01 01 29 Sorbitol Dehydrogenase
Lipoprotein lipase kit 44352 11 01 01 23 Lipase
Lipoprotein X kit 44375 12 01 04 90 Other Lipoproteins
MRSA coagulase typing kit 44376 13 03 04 07 Enzymes (e.g. Bromelin / Papain, etc.)
Beta-lipoprotein kit 44378 11 02 01 20 Lipoprotein, Chemical determination/detection
PIVKA-II kit 44379 12 03 90 90 Other Other Tumour Markers
Anti-agalactsyl immunoglobulin G kit 44385 12 10 90 90 Other Other Auto-Immune Disease Tests
Apolipoprotein C-III kit 44391 12 01 04 90 Other Lipoproteins
Apolipoprotein C-II kit 44392 12 01 04 90 Other Lipoproteins
Granulocyte elastase kit 44398 12 01 90 90 Other Other Plasma Proteins
Cortisol kit, urinalysis 44399 12 06 02 04 Cortisol
Injector, laboratory, high-pressure liquid chromatography 44407 21 05 30 02 HPLC Consumables
Culture identification kit, Mycobacterium 44408 14 01 03 10 Mycobacteria media (Bottles)
Processor, petri dish 44413 24 09 10 01 Other_MCB Hardware + dedicated accessories + software
Factor VIII ristocetin cofactor activity kit 44416 13 02 02 07 Coagulation factor VIII
Activated protein C-resisant factor V kit 44418 13 02 06 11 APC Resistance
Platelet aggregation kit 44419 13 02 04 01 Aggregation Factors
Luminescent immunoassay analyser 44420 21 02 10 01 IC Hardware + dedicated accessories + software
Pyruvate kinase kit 44421 11 01 01 90 Other Enzymes
GOR antibody kit 44425 12 10 90 90 Other Other Auto-Immune Disease Tests
Hepatitis C virus group-specific antigen kit 44426 15 02 03 01 HCV Antigen
Rickettsia tsutsugamushi antibody kit 44428 15 01 90 05 Rickettsia
Lung cancer-associated protein kit 44430 12 03 03 90 Other Oncoproteins
Major Bcr-Abl nucleic acid kit 44431 12 03 90 90 Other Other Tumour Markers
L-fucose kit 44432 11 02 01 90 Other Substrates
Pancreatic oncofetal antigen kit 44433 12 03 01 90 Other Cancer Antigens
Glycosylated haemoglobin control 44435 12 50 01 16 Individual and Specified Hormones Controls
Galactose-1-phosphate uridyl transferase kit 44436 14 02 05 90 Other Manual Susceptibility Testing
Progastrin releasing peptide precursor kit 44438 12 06 90 90 Other Individual and Specified Hormones
Thrombomodulin kit 44439 13 02 06 90 Other Coagulation Inhibitors
Basic foetoprotein kit 44440 12 03 90 01 Alphafetoprotein
Surfactant apoprotein A kit 44441 12 01 04 90 Other Lipoproteins
Serum amyloid A protein kit 44442 12 01 90 90 Other Other Plasma Proteins
Human brain natriuretic peptide kit 44443 12 13 01 01 Atrial- Brain Natriuric Peptide (incl. Pro-ANP/BNP)
Procollagen III peptide kit 44444 12 06 03 04 Collagen Type III C-terminal Propeptide
Antibiotic susceptibility testing kit, bacterial 44448 14 02 05 01 MIC Systems - Manual
Bacterial toxin detection kit 44449 14 90 90 90 Other Other Microbiology Tests

Page 107 of 108
Fungal identification kit 44450 14 03 04 02 Identification Systems for Fungi - Manual

Culture identification kit, bacterial 44456 14 02 02 Biochemical Identification - Manual
Antibiotic sensitivity tester 44497 24 01 10 01 SI Hardware + dedicated accessories + software
Chromium kit 44558 11 02 01 90 Other Substrates
3-Hydroxybutyric acid self-test kit 44562 11 70 01 90 Other Blood Test Strips
Vitamin D kit, multiple hydroxylated metabolite 44587 12 06 03 10 25-Hydroxyvitamin D3
Test strip kit, leukocyte, urinalysis 44611 11 70 02 01 Urine Single Test Strips (incl. tablets)
3a-diol-G kit 44612 12 05 01 12 Androstanediol-Glucuronide
Blood culture bottle 44644 14 01 06 01 Adult Bottles (Blood Culture -Autom.)
Pipette, electronic, single-function 44646 00 00 00 00 Not for IVD use
Matrix metalloproteinase-3 kit 44647 12 03 90 16 Matrix-Metalloproteinases
Laboratory equipment, gel dryer 44652 00 00 00 00 Not for IVD use
Cholesterol kit, free 44653 11 02 01 05 Cholesterol

Page 108 of 108

GMDN Edma Codes

Hochgeladen von

Dokumentinformationen

Originaltitel

Copyright

Verfügbare Formate

Dieses Dokument teilen

Dokument teilen oder einbetten

Freigabeoptionen

Stufen Sie dieses Dokument als nützlich ein?

Sind diese Inhalte unangemessen?

Copyright:

Verfügbare Formate

GMDN Edma Codes

Hochgeladen von

Copyright:

Verfügbare Formate

GMDN to EDMA code

GMDN Term GMDN Code EDMA Code EDMA Term

No Equivalent GMDN term 0 11 01 01 09 Angiotensin Converting Enzyme (CC) IC =>12.06.02.03

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

No Equivalent GMDN term 0 11 90 01 10 Electrophoresis Media (unassignable)

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

No Equivalent GMDN term 0 12 07 30 90 Other Multiple Anemia / Vitamine Tests

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

No Equivalent GMDN term 0 12 90 01 70 Buffers (unassignable ), Supplem. Reagents, etc (IC)

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

No Equivalent GMDN term 0 14 01 02 30 Dip Slides (Bacteriology)

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

No Equivalent GMDN term 0 15 02 01 40 Hepatitis A Virus - NA Reagents

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

No Equivalent GMDN term 0 15 04 40 13 LCM Virus - NA Reagents

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

No Equivalent GMDN term 0 16 01 02 05 Hypertension

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

No Equivalent GMDN term 0 27 01 30 01 MA Consumables

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Mixer, clinical laboratory 15161 00 00 00 00 Not for IVD use

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Centrifuge, floor, nonrefrigerated 17177 28 01 10 01 SP Hardware + accessories + software

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Reagent, Neisseria gonorrhoeae detection 17316 15 01 02 01 Gonococcal Antigen Detection

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Reagent, immunoglobulin D 17370 12 01 01 03 Immunoglobulin D

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Analyser, point-of-care, breath, hydrogen 17476 00 00 00 00 Not for IVD use

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Oxalate kit 30175 11 02 01 23 Oxalate

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Clinical chemistry calibrator, multi-component 30216 11 50 03 01 Calibrators Multicomponent (CC)

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Apolipoprotein A-I kit 30256 12 01 04 01 Apolipoprotein A I

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Beta2-microglobulin kit 30296 12 03 90 02 Beta2-Microglobulin

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

C-peptide kit 30336 12 06 01 01 C-Peptide

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Erythropoietin kit 30376 12 07 01 01 Erythropoietin

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Caffeine kit 30416 12 08 04 01 Caffeine

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Anticytoplasmic antibody kit 30456 12 10 01 03 Anti cytoplasmic - Antibodies

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Anti-staphylolysin reaction, quantitative 30496 12 11 01 06 Anti-Staphylolysin (qualititative)

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Platelet control 30536 13 01 20 05 Platelet Control

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

D-dimer kit 30576 13 02 05 03 D-Dimer

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Interferon a/B/y kit 30617 13 06 01 01 Interferons (a,b,y)

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Mycobacterium susceptibility test kit 30658 14 02 05 04 Mycobacteria Susceptibility Testing

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Mycobacterium antigen kit 30698 15 01 07 01 Mycobacterial Antigen Detection

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

Hepatitis B virus e antibody immunoglobulin M kit 30739 15 02 02 26 Hepatitis Be Antibody IgM

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf www.CE-marking.com www.CE-marking.eu