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Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
HBV HBsAg Assays - Hepatitis B Surface Antigen
Anti-HBc Assays - Hepatitis B Virus Core Antigen
HBV Nucleic Acid Assays - Hepatitis B Virus
HCV Anti-HCV Assays - Hepatitis C Virus Encoded Antigen
HCV Nucleic Acid Assays - Hepatitis C Virus
HIV Anti-HIV-1 Assays - Human Immunodeficiency Virus Type 1
HIV-1 Nucleic Acid Assays - Human Immunodeficiency Virus Type 1
Anti-HIV Specimen Collection Devices, Testing Services, and Home Test Kits
Anti-HIV-2 Assays - Human Immunodeficiency Virus Type 2
Anti-HIV-1/2 Assays - Human Immunodeficiency Virus Types 1 and 2
Anti-HIV-1/2 and HIV-1 Antigen Combo Assays
HTLV Anti-HTLV-I/II Assays - Human T-Lymphotropic Virus Types I and II
T. pallidum Anti-T. Pallidum Assays - Treponema pallidum (Syphilis)
T. cruzi Anti- T. cruzi Assays - Trypanosoma cruzi (T. cruzi)
WNV WNV Nucleic Acid Assays - West Nile Virus
CMV Anti-CMV Assays - Cytomegalovirus
Multiplex Multiplex Assays
1
Return to the Infectious Disease Tests page
HBsAg Assays (detect Hepatitis B Surface Antigen)
Tradename Infectious Format Specimen Use Manufacturer Approval STN
Agent Date
ABBOTT PRISM HBV ChLIA Serum/ Donor Abbott 7/18/2006 BL103766
HBsAg; ABBOTT Plasma/ Screening: Laboratories
PRISM HBsAg Cadaveric Qualitative Abbott Park, IL
2 ChLIA - specific Serum detection of US License
Confirmatory
antibody HBsAg. 0043
neutralization Confirmatory:
To confirm the
presence of
HBsAg in
samples found
to be
repeatedly
reactive by the
ABBOTT PRISM
HBsAg assay.
Genetic Systems HBV EIA Serum / In Vitro Bio-Rad 1/23/2003 BL103590
HBsAg EIA 3.0; Plasma / Diagnostic, Laboratories
Genetic Systems Cadaveric Donor Redmond, WA
HBsAg Serum Screening: US License
Confirmatory Qualitative 1109
Assay 3.0
3 detection of
HBsAg.
Confirmatory:
To confirm the
presence of
HBsAg in
reactive
specimens.
Return to TOC
Anti-HBc Assays (detect antibodies to Hepatitis B Virus Core Antigen)
Tradename Infectious Format Specimen Use Manufacturer Approval STN
Agent Date
ORTHO HBc ELISA HBV ELISA Serum / In Vitro Ortho-Clinical 4/23/1998 BL103062
Test System Plasma Diagnostic, Diagnostics,
Donor Inc
screening: Raritan, NJ
Qualitative
detection of
total antibody
to hepatitis B
core antigen.

18/02/2014 11:54:41
ABBOTT PRISM HBV ChLIA Serum / Donor Abbott 10/13/2005 BL103785
HBcore
4 Plasma Screening: Laboratories
Qualitative Abbott Park, IL
detection of US License
total antibody 0043
to hepatitis B
core antigen.
Return to TOC
HBV Nucleic Acid Assays (detect Hepatitis B Virus DNA), see also Multiplex Assays
Tradename Infectious Format Specimen Use Manufacturer Approval STN
Agent Date
UltraQual HBV HBV PCR Plasma Source Plasma National 9/1/2011 BL125193
PCR Assay
5 Donor Genetics
Screening: Institute Los
Qualitative Angeles, CA
detection of US License
HBV DNA. For 1582
in-house use
only at NGI.
COBAS HBV PCR Plasma/ Donor Roche 4/21/2005 BL125090
AmpliScreen HBV cadaveric Screening: Molecular
Test6 serum or Qualitative Systems, Inc
plasma detection of Pleasanton, CA
HBV DNA. US License
1636
Return to TOC
Anti-HCV Assays (detect antibodies to Hepatitis C Virus Encoded Antigen)
Tradename Infectious Format Specimen Use Manufacturer Approval STN
Agent Date
Abbott PRISM HCV ChLIA Serum / Donor Abbott 7/11/2007 BL103762
HCV7 Plasma/ screening: Laboratories
Cadaveric Qualitative Abbott Park, IL
serum detection of US License
antibodies to 0043
hepatitis C
virus.
Ortho HCV HCV EIA Serum / Donor Ortho-Clinical 4/23/1998 BL103065
Version 3.0 ELISA Plasma Screening: Diagnostics, 2/18/2009
Test System8 Qualitative Inc
detection of Raritan, NJ
antibodies to US License
hepatitis C 1236
virus.
Return to TOC
HCV Nucleic Acid Assays (detect Hepatitis C Virus RNA), see also Multiplex Assays
Tradename Infectious Format Specimen Use Manufacturer Approval STN
Agent Date
Hepatitis C Virus HCV PCR Plasma Source Plasma BioLife Plasma 2/9/2007 BL125101
RT PCR Assay
9 Donor Services, L.P.
Screening: Deerfield, IL
Qualitative US License
detection of 1640
HCV RNA. For
in house use
only by Baxter
Healthcare
International.
UltraQual HCV RT- HCV PCR Plasma Source Plasma National 9/18/2001 BL103868
PCR Assay
10 Donor Genetics
Screening: Institute
Qualitative Los Angeles,
detection of CA
HCV RNA. For US License
in house use 1582
only at NGI.
COBAS HCV PCR Plasma/ Donor Roche 12/3/2002 BL125045
AmpliScreen HCV Cadaveric Screening: Molecular
Test11, ver 2.0 serum or Qualitative Systems, Inc
plasma detection of Pleasanton, CA

18/02/2014 11:54:41
 HCV RNA. US License
Donor 1636
Supplemental:
To confirm HCV
infection for
specimens that
are repeatedly
reactive on a
licensed donor
screening test
for antibodies
to HCV, and
reactive on the
COBAS
AmpliScreen
HCV Test,
v2.0.
Return to TOC
Anti-HIV-1 Assays (detect antibodies to Human Immunodeficiency Virus type 1)
Tradename) Infectious Format Specimen Use Manufacturer Approval STN
Agent Date
Fluorognost HIV-1 HIV-1 IFA Serum / Diagnostic and Sanochemia 2/5/1992 BL103288
IFA Plasma Donor Pharmazeutika 5/14/1996 BL103651
Dried Blood Supplemental: AG
Spot Qualitative Vienna,
detection of Austria
antibodies to US License
HIV-1 for use 1631
as an
additional,
more specific
test in
specimens
found to be
repeatedly
reactive by
screening
procedures.
Donor
Screening:
Only in special
cases.
Cambridge HIV-1 WB Serum / Diagnostic and Maxim BL103843
Biotech HIV-1 Plasma Donor Biomedical, 5/28/1998
Western Blot Kit
12 Supplemental: Inc.
Qualitative Rockville, MD
detection of US License
antibodies to 1741
HIV-1 for use
as an
additional,
more specific
test in
specimens
found to be
repeatedly
reactive by
screening
procedures.
GS HIV-1 Western HIV-1 WB Serum / Diagnostic and Bio-Rad 11/13/1998 BL103655
Blot Plasma Donor Laboratories
Dried Blood Supplemental: Redmond, WA
Spot Qualitative US License
detection of 1109
antibodies to
HIV-1 for use
as an
additional,
more specific
test in
specimens
found to be
repeatedly

18/02/2014 11:54:41
 reactive by
screening
procedures.
Avioq HIV-1 HIV-1 EIA Serum, In Vitro Avioq Inc., 9/21/2009 BP090022
Microelisa Plasma, Dried Diagnostic: Rockville, MD
System
13 Blood Spot, Qualitative
Oral Fluid detection of
antibodies to
HIV-1.
Maxim (Calypte) HIV-1 EIA Urine In Vitro Maxim BP000009
HIV-1 Urine EIA Diagnostic: Biomedical, 1/12/2001
Qualitative Inc.
detection of Rockville, MD
antibodies to US License
HIV-1. 1741
INSTI HIV-1 HIV-1 Rapid Plasma / In Vitro bioLytical 11/29/2010 BP090032
Antibody Test Immunoassay Whole Blood Diagnostic: Laboratories
Kit14 (veni-puncture Qualitative Inc.
and detection of British
fingerstick) antibodies to Columbia,
HIV-1. Canada
Reveal Rapid HIV- HIV-1 Rapid Serum / In Vitro MedMira 4/16/2003 BP000023
1 Antibody Test15 Immunoassay Plasma Diagnostic: Laboratories,
Qualitative Inc.
detection of Halifax, Nova
antibodies to Scotia
HIV-1; point-of Canada
-care test.
OraSure HIV-1 HIV-1 WB Oral Fluid Diagnostic OraSure 6/3/1996 BP950004
Western Blot Kit16 Supplemental: Technologies
Qualitative Bethlehem, PA
detection of
antibodies to
HIV-1 for use
as an
additional,
more specific
test in oral
fluid specimens
found to be
repeatedly
reactive by the
Oral Fluid
Vironostika HIV
-l Microelisa
System.
Cambridge HIV-1 WB Urine Diagnostic Maxim 6/21/2001 BP010009
Biotech HIV-1 Supplemental: Biomedical,
Urine Western Qualitative Inc.
Blot Kit
17 detection of Rockville, MD
antibodies to US License
HIV-1 for use 1741
as an
additional,
more specific
test in urine
specimens
found to be
repeatedly
reactive by
Maxim HIV-1
Urine EIA.
Return to TOC
HIV-1 Nucleic Acid Assays (detect Human Immunodeficiency Virus type 1 RNA), see also Multiplex Assays
Tradename Infectious Format Specimen Use Manufacturer Approval STN
Agent Date
Human HIV-1 Qualitative PCR Plasma Source Plasma BioLife Plasma 1/31/2007 BL125100
Immunodeficiency Donor Services, L.P.
Virus, Type 1 RT Screening: Deerfield, IL
PCR Assay18 Qualitative US License
detection of 1640

18/02/2014 11:54:41
 HIV-1 RNA. For
in-house use
only by Baxter
Healthcare
International.
UltraQual HIV-1 HIV-1 Qualitative PCR Plasma Source Plasma National 9/18/2001 BL103902
RT-PCR Assay
19 Donor Genetics
Screening: Institute
Qualitative Los Angeles,
detection of CA
HIV-1 RNA. For US License
in house use 1582
only at NGI.
COBAS HIV-1 Qualitative PCR Plasma/ Donor Roche 12/20/2002 BL125059
AmpliScreen HIV- Cadaveric Screening: Molecular
1 Test, ver 1.520 serum or Qualitative Systems, Inc.
plasma detection of Pleasanton, CA
HIV-1 RNA. US License
1636
APTIMA HIV-1 HIV-1 TMA Plasma/ In Vitro Gen-Probe, 10/4/2006 BL103966
RNA Qualitative Serum Diagnostic: Inc.,
Assay21 Qualitative San Diego, CA
detection of US License
HIV-1 RNA. 1592
Abbott RealTime HIV-1 Quantitative PCR Plasma Patient ABBOTT 5/11/2007 BP060002
HIV-122 Monitoring: Molecular,
Quantitation of Inc., Des
HIV-1 RNA in Plaines, IL
plasma of HIV-
1 infected
individuals.
Amplicor HIV-1 HIV-1 Quantitative PCR Plasma Patient Roche 3/2/1999 BP950005
Monitor Test23 Monitoring: Molecular
Quantitation of Systems, Inc.
HIV-1 RNA in Pleasanton, CA
plasma of HIV- US License
1 infected 1636
individuals.
COBAS HIV-1 Quantitative PCR Plasma Patient Roche 5/11/2007 BP050069
AmpliPrep/COBAS Monitoring: Molecular
TaqMan HIV-1 Quantitation of Systems, Inc.
Test
24 HIV-1 RNA in Pleasanton, CA
plasma of HIV- US License
1 infected 1636
individuals.
Versant HIV-1 HIV-1 Quantitative PCR Plasma Patient Siemens 9/11/2002 BP000028
RNA 3.0 (bDNA)
25 Monitoring: Healthcare
Quantification Diagnostics,
of HIV-1 RNA Inc.
in plasma of
HIV-1 infected
individuals.
ViroSeq HIV-1 HIV-1 Genotyping Plasma Patient Celera 6/11/2003 BK030033,
Genotyping Monitoring: For Diagnostics 7/10/2008 BK080026
System
26 detecting HIV Alameda, CA
genomic
mutations (in
the protease
and part of the
reverse
transcriptase
regions of HIV)
that confer
resistance to
specific types
of antiretroviral
drugs, as an
aid in
monitoring and
treating HIV
infection.

18/02/2014 11:54:41
Trugene HIV-1 HIV-1 Genotyping Plasma Patient Siemens 4/24/2002 BK020005,
Genotyping Kit Monitoring: For Healthcare 3/27/2012
and Open Gene detecting HIV Diagnostics, BK120013
DNA Sequencing genomic Inc.
System
27 mutations (in
the protease
and part of the
reverse
transcriptase
regions of HIV)
that confer
resistance to
specific types
of antiretroviral
drugs, as an
aid in
monitoring and
treating HIV
infection.
Return to TOC
Anti-HIV Specimen Collection Devices, Testing Services, and Home Test Kits
Tradename Infectious Format Specimen Use Manufacturer Approval STN
Agent Date
Home Access HIV- HIV-1 Dried Blood Spot Dried Blood In Vitro Home Access 7/22/1996 BP950002
1 Test System28 Collection Device Spot Diagnostic: Health Corp.,
Self-use by Hoffman
people who Estates, IL
wish to obtain
anonymous
HIV testing
OraSure HIV-1 HIV-1 Oral Specimen Oral Fluid For Use with OraSure 12/23/1994 BP910001
Oral Specimen Collection Device HIV diagnostic Technologies
Collection Device assays that Bethlehem, PA
have been
approved for
use with this
device.
OraQuick In- HIV-1, HIV Immunoassay Oral fluid Over-the- OraSure 07/03/2012 BP120001
Home HIV Test29 -2 counter (OTC) Technologies
diagnostic Bethlehem, PA
home-use
test. A
positive result
is preliminary
and follow-up
confirmatory
testing is
needed.
Return to TOC
Anti-HIV-2 Assays(detect antibodies to Human Immunodeficiency Virus type 2)
Tradename Infectious Format Specimen Use Manufacturer Approval STN
Agent Date
Genetic Systems HIV-2 EIA Serum / In Vitro Bio-Rad 4/25/1990 BL103227
HIV-2 EIA Plasma Diagnostic, Laboratories
Donor Redmond, WA
Screening: US License
Qualitative 1109
detection of
antibodies to
HIV-2.
Return to TOC
Anti-HIV-1/2 Assays (detect antibodies to Human Immunodeficiency Virus types 1 and 2)
Tradename Infectious Format Specimen Use Manufacturer Approval STN
Agent Date
ABBOTT PRISM HIV-1, HIV ChLIA Plasma / In Vitro Abbott 9/18/2009 BL125318
HIV O Plus -2 Serum/ Diagnostic, Laboratories
assay30 Cadaveric Donor Abbott Park, IL
Serum Screening: US License
Qualitative 0043
detection of

18/02/2014 11:54:41
 antibodies to
HIV-1 groups
M and O
and/or
antibodies to
HIV-2.
Genetic Systems HIV-1, HIV EIA Serum / In Vitro Bio-Rad 8/5/2003 BL125030
HIV-1/HIV-2 Plus -2 Plasma / Diagnostic, Laboratories
O EIA
31 Cadaveric Donor Redmond, WA
Serum Screening: US License
Qualitative 1109
detection of
antibodies to
HIV-1 (Groups
M and O)
and/or HIV-2.
ADVIA Centaur HIV-1, HIV Microparticle Plasma/Serum In Vitro Siemens 5/18/2006 BP050030
HIV 1/O/2 Rapid32 -2 Chemi- Diagnostic: Healthcare
Test luminometric Qualitative Diagnostics,
Immunoassay determination Inc.
of antibodies to
HIV-1,
including
Group O,
and/or HIV-2.
VITROS HIV- HIV-1, HIV Immunometric Plasma/Serum In Vitro Ortho-Clinical 3/27/2008 BP050051
1/HIV-2 Reagent -2 Diagnostic: Diagnostics,
Pack and Qualitative Inc
Calibrator33 detection of Raritan, NJ
antibodies to US License
HIV-1 and/or 1236
HIV-2.
Multispot HIV- HIV-1, HIV Rapid Plasma / In Vitro Bio-Rad 11/12/2004 BP040046
1/HIV-2 Rapid -2 Immunoassay Serum Diagnostic: Laboratories
Test34 Qualitative Redmond, WA
detection of US License
antibodies to 1109
HIV-1 and/or
HIV-2.
SURE CHECK HIV HIV-1, HIV Rapid Fingerstick & In Vitro Chembio 5/25/2006 BP050009
1/2 ASSAY
35 -2 Immunoassay venous whole Diagnostic: Diagnostic
blood, serum, Qualitative Systems, Inc.
plasma detection of Medford, NY
antibodies to
HIV-1 and/or
HIV-2; point-of
-care test.
HIV 1/2 STAT-PAK HIV-1, HIV Rapid Fingerstick & In Vitro Chembio 5/25/2006 BP050010
ASSAY
36 -2 Immunoassay venous whole Diagnostic: Diagnostic
blood, serum, Qualitative Systems, Inc.
plasma detection of Medford, NY
antibodies to
HIV-1 and/or
HIV-2; point-of
-care test.
OraQuick HIV-1, HIV Rapid Oral Fluid, In Vitro OraSure 11/7/2002 BP010047
ADVANCE Rapid -2 Immunoassay Plasma, Whole Diagnostic: Technologies 6/22/2004
HIV-1/2 Antibody Blood Qualitative Bethlehem, PA
Test
37 (venipuncture detection of
and antibodies to
fingerstick) HIV-1 and/or
HIV-2; point-of
-care test.
Chembio DPP HIV-1, HIV Rapid Immuno- Oral Fluid, In Vitro Chembio 12/19/2012 BP120032
HIV 1/2 Assay
38 -2 chromatographic Serum, Diagnostic: Diagnostic
Assay Plasma, Qualitative Systems, Inc.
Whole Blood detection of Medford, NY
(Venipuncture, antibodies to
Fingerstick) HIV-1 and/or
HIV-2; point-of
-care test.

18/02/2014 11:54:41
Uni-Gold HIV-1, HIV Rapid EIA Serum, In Vitro Trinity Biotech 12/23/2003 BP030025
Recombigen -2 Plasma, Diagnostic: Jamestown, 02/04/2013
HIV-1/2 Whole Blood Qualitative NY
(Venipuncture, detection of
Fingerstick) antibodies to
HIV-1 and/or
HIV-2; point-of
-care test.
Return to TOC
Anti-HIV-1/2 and HIV-1 Antigen Combo Assays (detect HIV-1 antigen and antibodies to HIV Types 1 and
2)
Tradename Infectious Format Specimen Use Manufacturer Approval STN
Agent Date
ARCHITECT HIV HIV-1, HIV CMIA Plasma / In Vitro Abbott 6/18/2010 BP090080
Ag/Ab Combo39 -2 Serum Diagnostic: Laboratories
Simultaneous Abbott Park, IL
qualitative US License
detection of 0043
HIV p24
antigen and
antibodies to
HIV-1 (group M
and group O)
and/or HIV-2.
GS HIV Ag/Ab HIV-1, HIV EIA Plasma / In Vitro Bio-Rad 7/22/2011 BP100064
Combo EIA40 -2 Serum Diagnostic: Laboratories
Simultaneous Redmond, WA
qualitative US License
detection of 1109
HIV p24
antigen and
antibodies to
HIV-1 (group M
and group O)
and/or HIV-2.

Alere HIV-1, HIV Immunoassay Serum, In Vitro Alere 8/8/2013 BP120037

DetermineTM -2 Plasma, Diagnostic: Scarborough,
HIV-1/2 Ag/Ab Whole Blood Simultaneous Inc.
Combo41 (Venipuncture, qualitative Scarborough,
Fingerstick) detection of ME
HIV p24
antigen and
antibodies to
HIV-1 and/or
HIV-2; point-of
-care test.
Return to TOC
Anti-HTLV-I/II Assays (detect antibodies to Human T-Lymphotropic Virus types I and II)
Tradename Infectious Format Specimen Use Manufacturer Approval STN
Agent Date
Avioq HTLV-I/II HTLV-1, EIA Lysate Serum / In Vitro Avioq, Inc. 03/26/2012 BL125394
Microelisa HTLV-2 Plasma Diagnostic, Research
42
System Donor Triangle Park,
Screening: NC 27709
Qualitative US License
detection of 1856
antibodies to
HTLV-I and
HTLV-II.
ABBOTT PRISM HTLV-1, ChLIA Serum / Donor Abbott 1/16/2008 BL103761
43 HTLV-2 Plasma Screening: Laboratories
HTLV-I/HTLV-II
Qualitative Abbott Park, IL
detection of US License
antibodies to 0043
HTLV-I and
HTLV-II.
Return to TOC
Anti-T. pallidum Assays (detect antibodies to Treponema pallidum)and other serological tests for Syphilis

18/02/2014 11:54:41
Tradename Infectious Format Specimen Use Manufacturer Approval STN
Agent Date
CAPTIATM T. pallidum EIA Serum, Plasma Donor Trinity Biotech 01/24/2002 K014233
Syphilis (T. Screening: Jamestown,
Pallidum)-G Qualitative NY
detection of
IgG antibodies
to Treponema
pallidum.
44
ASI TPHA Test T. pallidum Micro- Serum Donor Arlington 1/30/2003 BK020031
hemagglutination Screening: Scientific, Inc
Qualitative Springville,
detection of UT
IgG and IgM
antibodies to
Treponema
pallidum.
Beckman-Coulter T. pallidum Micro- Serum, Plasma Donor Fujirebio 2/21/2003 BK030007
(Olympus) PK TP hemagglutination Screening: Diagnostics
System45 Qualitative Inc..
detection of Malvern, PA
IgG and IgM
antibodies to
Treponema
pallidum.

TPHA Screen46 T. pallidum Hemagglutination Serum, Plasma Donor Immucor, Inc 10/24/2012 BK120021
Screening: Norcross, GA
Qualitative
detection of
IgG and IgM
antibodies to
Treponema
pallidum.
Return to TOC
Anti- T. cruzi Assays (detect antibodies to Trypanosoma cruzi)
Tradename Infectious Format Specimen Use Manufacturer Approval STN
Agent Date
Abbott Prism T. cruzi EIA Serum / Donor Abbott 4/30/2010 BL125361
47
Chagas Plasma Screening: Laboratories
Qualitative Abbott Park, IL
detection of US License
antibodies to T. 0043
cruzi.
ORTHO T. cruzi T. cruzi EIA Serum / Donor Ortho-Clinical 12/13/2006 BL125161
ELISA Test Plasma / Screening: Diagnostics,
48
System Cadaveric Qualitative Inc.
detection of Raritan, NJ
antibodies to T. US License
cruzi. 1236
Return to TOC
WNV Nucleic Acid Assays (detect West Nile Virus RNA
Tradename Infectious Format Specimen Use Manufacturer Approval STN
Agent Date
Procleix West Nile WNV Nucleic Acid Test Plasma/ Donor Gen-Probe, 12/1/2005 BL125121
Virus (WNV) (TMA) Cadaveric Screening: Inc.,
49 plasma or Qualitative San Diego, CA
Assay
serum detection of US License
West Nile Virus 1592
(WNV) RNA.
COBAS TaqScreen WNV PCR Plasma/ Donor Roche 8/28/2007 BL125245
West Nile Virus Cadaveric Screening: Molecular
50 plasma or Qualitative Systems, Inc.
Test
serum detection of Pleasanton, CA
West Nile Virus US License
(WNV) RNA. 1636
Return to TOC
Anti-CMV Assays (detect antibodies to Cytomegalovirus)

18/02/2014 11:54:41
Tradename Infectious Format Specimen Use Manufacturer Approval STN
Agent Date
Capture - CMV CMV Solid phase red Serum, Plasma Donor Immucor, Inc. 12/22/1995 BK950029
cell adherence Screening: Norcross, GA
Qualitative
detection of
IgG and IgM
antibodies to
CMV.
Olympus PK CMV- CMV Passive particle Serum, Plasma Donor Fujirebio 9/20/2007 BK070030
PA System
51 agglutination Screening: Diagnostics,
Qualitative Inc.
detection of Malvern, PA
IgG and IgM
antibodies to
CMV.
Return to TOC
Multiplex Assays
Tradename Infectious Format Specimen Use Manufacturer Approval STN
Agent Date
COBAS TaqScreen HCV, HIV- PCR Plasma/ Donor Roche 12/30/2008 BL125255
MPX Test52 1, HIV-2 Cadaveric Screening: Molecular
plasma or Simultaneous Systems, Inc.
serum qualitative Pleasanton, CA
detection of US License
HIV-1 Group M 1636
and Group O
RNA, HIV-2
RNA, and HCV
RNA.
Procleix Ultrio HBV, HCV, Nucleic Acid Test Plasma/ Donor Gen-Probe, 10/3/2006 BL125113
Assay53 HIV-1 (TMA) Serum/ Screening: Inc.,
Cadaveric Simultaneous San Diego, CA
plasma or qualitative US License
serum detection of 1592
HBV DNA, HCV
RNA, and HIV-
1 RNA.
Procleix Ultrio HBV, HCV, Nucleic Acid Test Plasma/ Donor Gen-Probe, 5/25/2012 BL125113
Plus Assay54 HIV-1 (TMA) Serum/ Screening: Inc.,
Cadaveric Simultaneous San Diego, CA
plasma or qualitative US License
serum detection of 1592
HBV DNA, HCV
RNA, and HIV-
1 RNA.

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Infectious Disease Tests55

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23. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091626.htm
24. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091618.htm
25. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091618.htm
26. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation
27. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation
28. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091475.htm
29. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm310436.htm
30. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/I
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32. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091217.htm
33. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091601.htm
34. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091222.htm
35. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091240.htm
36. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091243.htm

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39. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/I
40. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm264723.htm
41. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm364651.htm
42. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/I
43. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/I
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45. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation
46. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation
47. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/I
48. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/I
49. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/I
50. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/I
51. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation
52. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/I
53. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/I
54. /BiologicsBloodVaccines/ucm335203.htm
55. /BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/I

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