Vaccines, Blood & Biologics

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

Return to the Infectious Disease Tests page


HBsAg Assays (detect Hepatitis B Surface Antigen)

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
ABBOTT PRISM HBsAg; ABBOTT PRISM HBsAg Confirmatory HBV ChLIA

 

ChLIA - specific antibody neutralization

Serum/ Plasma/ Cadaveric Serum Donor Screening: Qualitative detection of HBsAg.
Confirmatory: To confirm the presence of HBsAg in samples found to be repeatedly reactive by the ABBOTT PRISM HBsAg assay.
Abbott Laboratories
Abbott Park, IL
US License 0043
7/18/2006 BL103766
Genetic Systems HBsAg EIA 3.0;
Genetic Systems HBsAg Confirmatory Assay 3.0
HBV EIA Serum / Plasma / Cadaveric Serum In Vitro Diagnostic,
Donor Screening: Qualitative detection of HBsAg.
Confirmatory: To confirm the presence of HBsAg in reactive specimens.
Bio-Rad Laboratories
Redmond, WA
US License 1109
1/23/2003 BL103590

Anti-HBc Assays (detect antibodies to Hepatitis B Virus Core Antigen)

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
ORTHO HBc ELISA Test System HBV ELISA Serum / Plasma In Vitro Diagnostic,
Donor screening: Qualitative detection of total antibody to hepatitis B core antigen.
Ortho-Clinical Diagnostics, Inc
Raritan, NJ
4/23/1998 BL103062
ABBOTT PRISM HBcore HBV ChLIA Serum / Plasma Donor Screening: Qualitative detection of total antibody to hepatitis B core antigen Abbott Laboratories
Abbott Park, IL
US License 0043
10/13/2005 BL103785

HBV Nucleic Acid Assays (detect Hepatitis B Virus DNA),see also Multiplex Assays

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
UltraQual™ HBV PCR Assay HBV PCR Plasma Source Plasma Donor Screening: Qualitative detection of HBV DNA. For in-house use only at NGI. National Genetics Institute Los Angeles, CA US License 1582 9/1/2011 BL125193
COBAS AmpliScreen HBV Test HBV PCR Plasma/ cadaveric serum or plasma Donor Screening: Qualitative detection of HBV DNA. Roche Molecular Systems, Inc
Pleasanton, CA
US License 1636
4/21/2005 BL125090

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Anti-HCV Assays (detect antibodies to Hepatitis C Virus Encoded Antigen)

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
Abbott PRISM HCV HCV ChLIA Serum / Plasma/ Cadaveric serum Donor screening: Qualitative detection of antibodies to hepatitis C virus. Abbott Laboratories
Abbott Park, IL
US License 0043
7/11/2007 BL103762
Ortho HCV Version 3.0 ELISA Test System HCV EIA Serum / Plasma Donor Screening: Qualitative detection of antibodies to hepatitis C virus. Ortho-Clinical Diagnostics, Inc
Raritan, NJ
US License 1236
4/23/1998
2/18/2009
BL103065

HCV Nucleic Acid Assays (detect Hepatitis C Virus RNA), see also Multiplex Assays

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
Hepatitis C Virus RT  PCR Assay HCV PCR Plasma Source Plasma Donor Screening: Qualitative detection of HCV RNA. For in house use only by Baxter Healthcare International. BioLife Plasma Services, L.P.
Deerfield, IL
US License 1640
2/9/2007 BL125101
UltraQual HCV RT-PCR Assay HCV PCR Plasma Source Plasma Donor Screening: Qualitative detection of HCV RNA. For in house use only at NGI. National Genetics Institute
Los Angeles, CA
US License 1582
9/18/2001 BL103868
COBAS AmpliScreen HCV Test, ver 2.0 HCV PCR Plasma/ Cadaveric serum or plasma Donor Screening: Qualitative detection of HCV RNA.
Donor 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.
Roche Molecular Systems, Inc
Pleasanton, CA
US License 1636
12/3/2002 BL125045

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Anti-HIV-1 Assays (detect antibodies to Human Immunodeficiency Virus type 1)

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
Fluorognost HIV-1 IFA HIV-1 IFA Serum / Plasma
Dried Blood Spot
Diagnostic and Donor Supplemental: Qualitative detection of antibodies to HIV-1 for use as an additional, more specific test in specimens found to be repeatedly reactive by screening procedures.
Donor Screening: Only in special cases.
Sanochemia Pharmazeutika AG
Vienna, Austria
US License 1631
2/5/1992
5/14/1996
BL103288
BL103651
Cambridge Biotech HIV-1 Western Blot Kit HIV-1 WB Serum / Plasma Diagnostic and Donor Supplemental: Qualitative detection of antibodies to HIV-1 for use as an additional, more specific test in specimens found to be repeatedly reactive by screening procedures. Maxim Biomedical, Inc.
Rockville, MD
US License 1741
5/28/1998 BL103843
GS HIV-1 Western Blot HIV-1 WB Serum / Plasma
Dried Blood Spot
Diagnostic and Donor Supplemental: Qualitative detection of antibodies to HIV-1 for use as an additional, more specific test in specimens found to be repeatedly reactive by screening procedures. Bio-Rad Laboratories
Redmond, WA
US License 1109
11/13/1998 BL103655
Avioq HIV-1 Microelisa System HIV-1 EIA Serum, Plasma, Dried Blood Spot, Oral Fluid In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1. Avioq Inc.,
Rockville, MD
9/21/2009 BP090022
Maxim (Calypte) HIV-1 Urine EIA HIV-1 EIA Urine In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1. Maxim Biomedical, Inc.
Rockville, MD
US License 1741
1/12/2001 BP000009
INSTI™ HIV-1 Antibody Test Kit HIV-1 Rapid Immunoassay Plasma / Whole Blood (veni-puncture and fingerstick) In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1. bioLytical Laboratories Inc.
British Columbia, Canada
11/29/2010 BP090032
Reveal Rapid HIV-1 Antibody Test HIV-1 Rapid Immunoassay Serum / Plasma In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1; point-of-care test. MedMira Laboratories, Inc.
Halifax, Nova Scotia
Canada
4/16/2003 BP000023
OraSure HIV-1 Western Blot Kit HIV-1 WB Oral Fluid Diagnostic Supplemental: Qualitative 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. OraSure Technologies
Bethlehem, PA
6/3/1996 BP950004
Cambridge Biotech HIV-1 Urine Western Blot Kit HIV-1 WB Urine Diagnostic Supplemental: Qualitative detection of antibodies to HIV-1 for use as an additional, more specific test in urine specimens found to be repeatedly reactive by Maxim HIV-1 Urine EIA Maxim Biomedical, Inc.
Rockville, MD
US License 1741
6/21/2001 BP010009

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HIV-1 Nucleic Acid Assays (detect Human Immunodeficiency Virus type 1 RNA), see also Multiplex Assays

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
Human Immunodeficiency Virus, Type 1 RT PCR Assay HIV-1 Qualitative PCR Plasma Source Plasma Donor Screening: Qualitative detection of HIV-1 RNA. For in-house use only by Baxter Healthcare International. BioLife Plasma Services, L.P.
Deerfield, IL
US License 1640
1/31/2007 BL125100
UltraQual HIV-1 RT-PCR Assay HIV-1 Qualitative PCR Plasma Source Plasma Donor Screening: Qualitative detection of HIV-1 RNA. For in house use only at NGI. >National Genetics Institute
Los Angeles, CA
US License 1582
9/18/2001 BL103902
COBAS AmpliScreen HIV-1 Test, ver 1.5 HIV-1 Qualitative PCR Plasma/ Cadaveric serum or plasma Donor Screening: Qualitative detection of HIV-1 RNA. Roche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
12/20/2002 BL125059
APTIMA HIV-1 RNA Qualitative Assay HIV-1 TMA Plasma/ Serum In Vitro Diagnostic: Qualitative detection of HIV-1 RNA. Gen-Probe, Inc.,
San Diego, CA
US License 1592
10/4/2006 BL103966
Abbott RealTime
HIV-1
HIV-1 Quantitative PCR Plasma Patient Monitoring: Quantitation of HIV-1 RNA in plasma of HIV-1 infected individuals. ABBOTT Molecular, Inc., Des Plaines, IL 5/11/2007 BP060002
Amplicor HIV-1 Monitor Test HIV-1 Quantitative PCR Plasma Patient Monitoring: Quantitation of HIV-1 RNA in plasma of HIV-1 infected individuals. Roche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
3/2/1999 BP950005
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test HIV-1 Quantitative PCR Plasma Patient Monitoring: Quantitation of HIV-1 RNA in plasma of HIV-1 infected individuals. Roche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
5/11/2007 BP050069
Versant HIV-1 RNA 3.0 (bDNA) HIV-1 Quantitative PCR Plasma Patient Monitoring: Quantification of HIV-1 RNA in plasma of HIV-1 infected individuals. Siemens Healthcare Diagnostics, Inc. 9/11/2002 BP000028
ViroSeq HIV-1 Genotyping System HIV-1 Genotyping Plasma Patient Monitoring: For detecting HIV 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. Celera Diagnostics
Alameda, CA
6/11/2003
7/10/2008
BK030033,
BK080026
Trugene HIV-1 Genotyping Kit and Open Gene DNA Sequencing System HIV-1 Genotyping Plasma Patient Monitoring: For detecting HIV 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. Siemens Healthcare Diagnostics, Inc. 4/24/2002
3/27/2012
BK020005,
BK120013

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Anti-HIV Specimen Collection Devices, Testing Services, and Home Test Kits

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
Home Access HIV-1 Test System HIV-1 Dried Blood Spot Collection Device Dried Blood Spot In Vitro Diagnostic: Self-use by people who wish to obtain anonymous HIV testing Home Access Health Corp.,
Hoffman Estates, IL
7/22/1996 BP950002
OraSure HIV-1 Oral Specimen Collection Device HIV-1 Oral Specimen Collection Device Oral Fluid For Use with HIV diagnostic assays that have been approved for use with this device. OraSure Technologies
Bethlehem, PA
12/23/1994 BP910001
OraQuick In-Home HIV Test HIV-1, HIV-2 Immunoassa Oral fluid Over-the-counter (OTC) diagnostic home-use test.  A positive result is preliminary and follow-up confirmatory testing is needed. OraSure Technologies
Bethlehem, PA
07/03/2012 BP120001

Anti-HIV-2 Assays(detect antibodies to Human Immunodeficiency Virus type 2)

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
Genetic Systems HIV-2 EIA HIV-2 EIA Serum / Plasma In Vitro Diagnostic,
Donor Screening: Qualitative detection of antibodies to HIV-2.
Bio-Rad Laboratories
Redmond, WA
US License 1109
4/25/1990 BL103227

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Anti-HIV-1/2 Assays (detect antibodies to Human Immunodeficiency Virus types 1 and 2)

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
ABBOTT PRISM HIV O Plus assay HIV-1, HIV-2 ChLIA Plasma / Serum/ Cadaveric Serum In Vitro Diagnostic,
Donor Screening: Qualitative detection of antibodies to HIV-1 groups M and O and/or antibodies to HIV-2.
Abbott Laboratories
Abbott Park, IL
US License 0043
9/18/2009 BL125318
Geenius HIV 1/2 Supplemental Assay HIV-1, HIV-2 HIV Detection Test Blood Used as specific test to confirm the presence of antibodies of HIV-1 and HIV-2 for the detection of specimens to be repeatedly reactive by screening procedures. Bio-Rad Laboratories, Inc
Redmond, WA
US License 1109
10/24/2014 BP140120
Genetic Systems HIV-1/HIV-2 Plus O EIA HIV-1, HIV-2 EIA Serum / Plasma / Cadaveric Serum In Vitro Diagnostic,
Donor Screening: Qualitative detection of antibodies to HIV-1 (Groups M and O) and/or HIV-2.
Bio-Rad Laboratories
Redmond, WA
US License 1109
8/5/2003 BL125030
ADVIA Centaur HIV 1/O/2 Rapid Test HIV-1, HIV-2 Microparticle Chemi-luminometric Immunoassay Plasma/Serum In Vitro Diagnostic: Qualitative determination of antibodies to HIV-1, including Group O, and/or HIV-2. Siemens Healthcare Diagnostics, Inc. 5/18/2006 BP050030
VITROS HIV-1/HIV-2 Reagent Pack and Calibrator HIV-1, HIV-2 Immunometric Plasma/Serum In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2. Ortho-Clinical Diagnostics, Inc
Raritan, NJ
US License 1236
3/27/2008 BP050051
Multispot HIV-1/HIV-2 Rapid Test HIV-1, HIV-2 Rapid Immunoassay Plasma / Serum In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2. Bio-Rad Laboratories
Redmond, WA
US License 1109
11/12/2004 BP040046
SURE CHECK HIV 1/2 ASSAY HIV-1, HIV-2 Rapid Immunoassay Fingerstick & venous whole blood, serum, plasma In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test. Chembio Diagnostic Systems, Inc.
Medford, NY
5/25/2006 BP050009
HIV 1/2 STAT-PAK ASSAY HIV-1, HIV-2 Rapid Immunoassay Fingerstick & venous whole blood, serum, plasma In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test. Chembio Diagnostic Systems, Inc.
Medford, NY
5/25/2006 BP050010
OraQuick ADVANCE Rapid HIV-1/2 Antibody Test HIV-1, HIV-2 Rapid Immunoassay Oral Fluid, Plasma, Whole Blood (venipuncture and fingerstick) In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test. OraSure Technologies
Bethlehem, PA
11/7/2002
6/22/2004
BP010047
Chembio DPP® HIV 1/2 Assay HIV-1, HIV-2 Rapid Immuno-chromatographic Assay Oral Fluid, Serum, Plasma,
Whole Blood (Venipuncture, Fingerstick)
In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test. Chembio Diagnostic Systems, Inc.
Medford, NY
12/19/2012 BP120032
Uni-Gold™ Recombigen® HIV-1/2 HIV-1, HIV-2 Rapid EIA Serum, Plasma,
Whole Blood (Venipuncture, Fingerstick)
In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test. Trinity Biotech
Jamestown, NY
12/23/2003
02/04/2013
BP030025

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Anti-HIV-1/2 and HIV-1 Antigen Combo Assays (detect HIV-1 antigen and antibodies to HIV Types 1 and 2)

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
ARCHITECT HIV Ag/Ab Combo HIV-1, HIV-2 CMIA Plasma / Serum In Vitro Diagnostic: Simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (group M and group O) and/or HIV-2. Abbott Laboratories
Abbott Park, IL
US License 0043
6/18/2010 BP090080
GS HIV Ag/Ab Combo EIA HIV-1, HIV-2 EIA Plasma / Serum In Vitro Diagnostic: Simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (group M and group O) and/or HIV-2. Bio-Rad Laboratories
Redmond, WA
US License 1109
7/22/2011 BP100064
Alere DetermineTM
HIV-1/2 Ag/Ab Combo
HIV-1, HIV-2 Immunoassay Serum, Plasma,
Whole Blood (Venipuncture, Fingerstick)
In Vitro Diagnostic: Simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 and/or HIV-2; point-of-care test. Alere Scarborough, Inc.
Scarborough, ME
8/8/2013 BP120037

Anti-HTLV-I/II Assays (detect antibodies to Human T-Lymphotropic Virus types I and II)

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
Avioq HTLV-I/II Microelisa System HTLV-1, HTLV-2 EIA Lysate Serum / Plasma In Vitro Diagnostic,
Donor Screening: Qualitative detection of antibodies to HTLV-I and HTLV-II.
Avioq, Inc.
Research Triangle Park, NC 27709
US License 1856
03/26/2012 BL125394
ABBOTT PRISM HTLV-I/HTLV-II HTLV-1, HTLV-2 ChLIA Serum / Plasma Donor Screening: Qualitative detection of antibodies to HTLV-I and HTLV-II.  Abbott Laboratories
Abbott Park, IL
US License 0043
1/16/2008 BL103761
MP Diagnostic HTLV Blot 2.4 HTLV-I, HTLV-II WB Serum/Plasma Donor Supplemental: Qualitative detection and differentiation of antibodies to HTLV-I and HTLV-II for use as an additional, more specific test in specimens found to be repeatedly reactive by screening procedures. MP Biomedicals Asia Pacific PTE. LTD 12/11/2014 BL125475

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Anti-T. pallidum Assays (detect antibodies to Treponema pallidum)and other serological tests for Syphilis

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
CAPTIATM Syphilis (T. Pallidum)-G T. pallidum EIA Serum, Plasma Donor Screening: Qualitative detection of IgG antibodies to Treponema pallidum. Trinity Biotech
Jamestown, NY
01/24/2002 K014233
ASI TPHA Test T. pallidum Micro-hemagglutination Serum Donor Screening: Qualitative detection of IgG and IgM antibodies to Treponema pallidum. Arlington Scientific, Inc
Springville,UT
1/30/2003 BK020031
Beckman-Coulter (Olympus) PK TP System T. pallidum Micro-hemagglutination Serum, Plasma Donor Screening: Qualitative detection of IgG and IgM antibodies to Treponema pallidum. Fujirebio Diagnostics Inc..
Malvern, PA
2/21/2003 BK030007
TPHA Screen T. pallidum Hemagglutination Serum, Plasma Donor Screening: Qualitative detection of IgG and IgM antibodies to Treponema pallidum. Immucor, Inc
Norcross, GA
10/24/2012 BK120021
ASiManager-AT™ T. pallidum Rapid Plasma Reagin (RPR) Test Serum, Plasma Donor Screening: Qualitative detection of reagin antibodies. Arlington Scientific, Inc.
Springville, UT.
2/24/2014 BK 130001

Anti- T. cruzi Assays (detect antibodies to Trypanosoma cruzi)

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
Abbott Prism Chagas T. cruzi EIA Serum / Plasma Donor Screening: Qualitative detection of antibodies to T. cruzi. Abbott Laboratories
Abbott Park, IL
US License 0043
4/30/2010 BL125361
ORTHO T. cruzi ELISA Test System T. cruzi EIA Serum / Plasma / Cadaveric Donor Screening: Qualitative detection of antibodies to T. cruzi. Ortho-Clinical Diagnostics, Inc.
Raritan, NJ
US License 1236
12/13/2006 BL125161

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WNV Nucleic Acid Assays (detect West Nile Virus RNA

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
Procleix West Nile Virus (WNV) Assay WNV Nucleic Acid Test (TMA) Plasma/ Cadaveric plasma or serum Donor Screening: Qualitative detection of West Nile Virus (WNV) RNA. Gen-Probe, Inc.,
San Diego, CA
US License 1592
12/1/2005 BL125121
COBAS TaqScreen West Nile Virus Test WNV PCR Plasma/ Cadaveric plasma or serum Donor Screening: Qualitative detection of West Nile Virus (WNV) RNA. Roche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
8/28/2007 BL125245

Anti-CMV Assays (detect antibodies to Cytomegalovirus)

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
Capture - CMV CMV Solid phase red cell adherence Serum, Plasma Donor Screening: Qualitative detection of IgG and IgM antibodies to CMV. Immucor, Inc.
Norcross, GA
12/22/1995 BK950029
Olympus PK CMV-PA System CMV Passive particle agglutination Serum, Plasma Donor Screening: Qualitative detection of IgG and IgM antibodies to CMV. Fujirebio Diagnostics, Inc.
Malvern, PA
9/20/2007 BK070030

Multiplex Assays

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
COBAS TaqScreen MPX Test HBV, HCV, HIV-1, HIV-2 PCR Plasma/ Cadaveric plasma or serum Donor Screening: Simultaneous qualitative detection of HBV DNA, HIV-1 Group M and Group O RNA, HIV-2 RNA, and HCV RNA. Roche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
12/30/2008 BL125255
COBAS TaqScreen MPX Test version 2.0 HBV, HCV, HIV-1, HIV-2 PCR Plasma Donor Screening: Simultaneous qualitative detection of HBV DNA, HIV-1 Group M and Group O RNA, HIV-2 RNA, and HCV RNA Roche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
12/19/2014 BL 125459
Procleix Ultrio Assay HBV, HCV, HIV-1 Nucleic Acid Test (TMA Plasma/ Serum/ Cadaveric plasma or serum Donor Screening: Simultaneous qualitative detection of HBV DNA, HCV RNA, and HIV-1 RNA. Gen-Probe, Inc.,
San Diego, CA
US License 1592
10/3/2006 BL125113
Procleix Ultrio Plus Assay HBV, HCV, HIV-1 Nucleic Acid Test (TMA) Plasma/ Serum/ Cadaveric plasma or serum Donor Screening: Simultaneous qualitative detection of HBV DNA, HCV RNA, and HIV-1 RNA. Gen-Probe, Inc.,
San Diego, CA
US License 1592
5/25/2012 BL125113

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Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 06/18/2015
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