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  1. Safety & Availability (Biologics)

Testing Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases

Table of Contents
Additional Resources
Information about tests currently recommended to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents and diseases under § 1271.80 and § 1271.85:

Note:

  • See product inserts for specific instructions regarding specimen collection.
  • Abbreviations:
    • ChLIA - Chemiluminescent immunoassay
    • CMIA - Chemiluminescent magnetic microparticle immunoassay
    • ECLIA - Electrochemiluminescence immunoassay
    • EIA - Enzyme immunoassay
    • ELISA - Enzyme-linked immunosorbent assay
    • NAT - Nucleic Acid Test
    • PCR - Polymerase chain reaction
    • RPR - Rapid plasma reagin
    • SDA - Strand displacement amplification
    • TMA - Transcription-mediated amplification

Licensed Donor Screening Tests

Hepatitis B Virus (HBV)

HBsAg Assays
(Detects Hepatitis B surface Antigen)

TradenameInfectious AgentFormatSpecimenUseManufacturerLicensure DateSTN
Elecsys HBsAg II and HBsAg II Auto ConfirmHBVECLIALiving: Plasma, serumDonor Screening:HBsAg
Confirmatory: To confirm the presence of HBsAg in samples repeatedly reactive when tested with the Elecsys HBsAg II assay
Roche Diagnostics, US License 23052/21/2024125802
ABBOTT Alinity s HBsAg; ABBOTT Alinity s HBsAg ConfirmatoryHBVCMIA
CMIA –
specific
antibody neutralization
Living: 
Plasma, Serum
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 Alinity s HBsAg assay
Abbott Ireland Diagnostics Division
Sligo, Ireland
US License 2094
6/14/2019BL125674
ABBOTT PRISM HBsAg; ABBOTT PRISM HBsAg ConfirmatoryHBVChLIA
ChLIA –
specific
antibody neutralization
Living: 
Plasma, Serum
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
7/18/2006BL103766
Genetic Systems HBsAg EIA 3.0; Genetic Systems HBsAg Confirmatory Assay 3.0HBVEIALiving:
Plasma, Serum
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
1/23/2003BL103590

Anti-HBc Assays
(Detects antibodies to Hepatitis B core antigen)

Note: The following anti-HBc donor screening assays detect total antibody (IgG + IgM) to HBc.

TradenameInfectious AgentFormatSpecimenUseManufacturerLicensure DateSTN
Elecsys Anti-HBc IIHBVECLIALiving: Plasma, SerumDonor Screening: Qualitative detection of antibodies to hepatitis B core antigenRoche Diagnostics, US License 23052/27/2024125804
ABBOTT Alinity s Anti-HBcHBVCMIALiving:
Plasma, Serum
Cadaveric:
Serum
Donor Screening: Qualitative detection of total antibody to hepatitis B core antigenAbbott GmbH & Co KG
Wiesbaden, Germany
US License 2095
8/09/2019BL125681
ABBOTT PRISM HBcoreHBVChLIALiving:
Plasma, Serum
Donor Screening: Qualitative detection of total antibody to hepatitis B core antigenAbbott Laboratories
Abbott Park, IL
US License 0043
10/13/2005BL103785
ORTHO HBc ELISA Test SystemHBVELISALiving:
Plasma, Serum
In Vitro Diagnostic, Donor screening: Qualitative detection of total antibody to hepatitis B core antigenOrtho-Clinical Diagnostics, Inc.
Raritan, NJ
4/23/1998BL103062

Hepatitis C Virus (HCV)

Anti-HCV Assays
(Detects antibodies to HCV)

TradenameInfectious AgentFormatSpecimenUseManufacturerLicensure DateSTN
Elecsys Anti-HCV IIHCVECLIALiving:
Plasma,
serum
Donor Screening:
Qualitative detection of antibodies to hepatitis C virus
Roche Diagnostics,
US License 2305
2/28/2024125803
Alinity s Anti- HCV II assayHCVCMIALiving:
Plasma, Serum
Cadaveric:
Plasma, Serum
Donor Screening:
Qualitative  detection of antibodies to hepatitis C virus
Abbott GmbH & Co KG
Wiesbaden, Germany
US License 2095
7/15/2022BL125759
ABBOTT Alinity s Anti-HCVHCVCMIALiving:
Plasma, Serum
Cadaveric:
Serum
Donor Screening: Qualitative detection of antibodies to hepatitis C virusAbbott GmbH & Co KG
Wiesbaden, Germany
US License 2095
7/15/2019BL125677
Ortho HCV Version 3.0 ELISA Test SystemHCVEIALiving: 
Plasma, Serum
Cadaveric:
Plasma, Serum
Donor Screening: Qualitative detection of antibodies to hepatitis C virusOrtho-Clinical Diagnostics, Inc.
Raritan, NJ
US License 1236
2/18/2009
4/23/1998
BL103065
Abbott PRISM HCVHCVChLIALiving: 
Plasma, Serum 
Cadaveric:
Serum
Donor screening: Qualitative detection of antibodies to hepatitis C virusAbbott Laboratories Abbott Park, IL
US License 0043
7/11/2007BL103762

Human Immunodeficiency Virus (HIV)-1 and 2

Anti-HIV-1 and Anti-HIV-2 Assays
(Detects antibodies to HIV Types 1 & 2)

TradenameInfectious AgentFormatSpecimenUseManufacturerLicensure DateSTN
Elecsys HIV DuoHIV-1,
HIV-2
ECLIALiving:
Plasma, Serum
Donor Screening:  Qualitative detection and differentiation of HIV-1 p24 antigen and antibodies to HIV, HIV-1 (groups M and O) and HIV-2Roche Diagnostics Indianapolis, IN                  US License 23056/13/2023125778
ABBOTT Alinity s HIV Ag/Ab ComboHIV-1,
HIV-2
CMIALiving: 
Plasma, Serum
Cadaveric:
Serum
Donor Screening: Simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (including groups O and M) and HIV-2Abbott GmbH & Co KG
Wiesbaden, Germany
US License 2095
7/23/2019BL125679
ABBOTT PRISM HIV O Plus assayHIV-1,
HIV-2
ChLIALiving: 
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-2Abbott Laboratories
Abbott Park, IL
US License 0043
9/18/2009BL125318
Genetic Systems HIV-1/HIV-2 Plus O EIAHIV-1,
HIV-2
EIALiving: 
Plasma, Serum
Cadaveric: 
Serum
In Vitro Diagnostic, Donor Screening: Qualitative detection of antibodies to HIV-1 (Groups M and O) and/or HIV-2Bio-Rad Laboratories
Redmond, WA
US License 1109
8/5/2003BL125030

HBV/HCV/HIV Multiplex NAT

(Detects HBV/HCV/HIV Nucleic Acids)


Tradename
Infectious AgentFormatSpecimenUseManufacturerLicensure DateSTN
cobas MPX TestHBV, HCV, HIV-1, HIV-2PCRLiving: 
Plasma, Serum
Cadaveric: 
Plasma, Serum
Donor Screening: Simultaneous qualitative detection of HBV DNA, HIV-1 Group M and Group O RNA, HIV-2 RNA, and HCV RNARoche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
1/17/2020
9/21/2017
10/21/2016
BL125576
Procleix Ultrio Elite AssayHBV, HCV, HIV-1, HIV-2Nucleic Acid Test
(TMA)
Living: 
Plasma, Serum
Cadaveric: 
Plasma, Serum
Donor Screening: Simultaneous qualitative detection of HBV DNA, HCV RNA, HIV-1 RNA and HIV-2 RNA (see package insert for more information on detection of HIV-1 Group O RNA)Grifols Diagnostics Solutions, Inc.
San Diego, CA
US License 2032
5/03/2018BL125652
cobas TaqScreen MPX Test version 2.0HBV, HCV, HIV-1, HIV-2PCRLiving: 
Plasma
Cadaveric: 
Plasma, Serum
Donor Screening: Simultaneous qualitative detection of HBV DNA, HIV-1 Group M and Group O RNA, HIV-2 RNA, and HCV RNARoche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
9/21/2017
12/19/2014
BL125459
Procleix Ultrio Plus AssayHBV, HCV, HIV-1Nucleic Acid Test
(TMA)
Living: 
Plasma, Serum
Cadaveric: 
Plasma, Serum
Donor Screening: Simultaneous qualitative detection of HBV DNA, HCV RNA, and HIV-1 RNA (see package insert for more information on detection of HIV-1 Group O RNA)Grifols Diagnostics Solutions, Inc.
San Diego, CA
US License 2032
5/25/2012BL125113
cobas TaqScreen MPX TestHBV, HCV, HIV-1, HIV-2PCRLiving: 
Plasma
Cadaveric: 
Plasma, Serum
Donor Screening: Simultaneous qualitative detection of HBV DNA, HIV-1 Group M and Group O RNA, HIV-2 RNA, and HCV RNARoche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
8/27/2009
12/30/2008
BL125255
Procleix Ultrio AssayHBV, HCV, HIV-1Nucleic Acid Test
(TMA)
Living: 
Plasma, Serum
Cadaveric:
Plasma, Serum
Donor Screening: Simultaneous qualitative detection of HBV DNA, HCV RNA, and HIV-1 RNA (see package insert for more information on detection of HIV-1 Group O RNA)Grifols Diagnostics Solutions, Inc.
San Diego, CA
US License 2032
10/3/2006BL125113

West Nile Virus (WNV)

WNV NAT
(Detects WNV RNA)

TradenameInfectious AgentFormatSpecimenUseManufacturerLicensure DateSTN
cobas WNV AssayWNVPCRLiving: 
Plasma
Cadaveric: 
Plasma, Serum
Donor Screening: Qualitative detection of West Nile Virus (WNV) RNARoche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
1/17/2020
11/2/2016
BL125575
cobas TaqScreen West Nile Virus TestWNVPCRLiving: 
Plasma
Cadaveric: 
Plasma
Donor Screening: Qualitative detection of West Nile Virus (WNV) RNARoche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
8/28/2007BL125245
Procleix West Nile Virus (WNV) AssayWNVNucleic Acid Test
(TMA)
Living: 
Plasma
Cadaveric: 
Plasma, Serum
Donor Screening: Qualitative detection of West Nile Virus (WNV) RNAGen-Probe, Inc.
San Diego, CA
US License 1592
12/1/2005BL125121

Human T-Lymphotropic Virus Types I & II (HTLV-I & II)

Anti-HTLV-I and Anti-HTLV-II Assays
(Detects antibodies to HTLV-I & II)

TradenameInfectious AgentFormatSpecimenUseManufacturerLicensure DateSTN
Elecsys HTLV-I/IIHTLV-1, HTLV-2ECLIALiving: 
Plasma, Serum
Donor Screening: Qualitative detection of antibodies to HTLV-I and HTLV-IIRoche Diagnostics Indianapolis, IN
US License 2305
10/17/2023BL125792
ABBOTT Alinity s HTLV-I/II AssayHTLV-1, HTLV-2CMIALiving: 
Plasma, Serum
Cadaveric: 
Serum
Donor Screening: Qualitative detection of antibodies to HTLV-I and HTLV-IIAbbott GmbH & Co KG
Wiesbaden, Germany
US License 2095
6/27/2019BL125675
Avioq HTLV-I/II Microelisa SystemHTLV-1, HTLV-2EIALiving: 
Plasma, Serum
Cadaveric: 
Plasma, Serum
In Vitro Diagnostic, Donor Screening: Qualitative detection of antibodies to HTLV-I and HTLV-IIAvioq, Inc.
Research Triangle Park, NC
US License 1856
03/26/2012BL125394
ABBOTT PRISM HTLV-I/HTLV-IIHTLV-1, HTLV-2ChLIALiving: 
Plasma, Serum
Donor Screening: Qualitative detection of antibodies to HTLV-I and HTLV-IIAbbott Laboratories
Abbott Park, IL
US License 0043
1/16/2008BL103761

Cleared NAT for Chlamydia trachomatis and Neisseria gonorrhoeae

Chlamydia trachomatis/Neisseria gonorrhoeae

Note: Although there are diagnostic tests available, there are currently no FDA-licensed, approved, or cleared tests for donor screening. In the absence of such screening tests, you must use an FDA-licensed, approved, or cleared diagnostic test labeled for the detection of these organisms in an asymptomatic, low-prevalence population (§ 1271.80(c)). The use of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) tests utilizing NAT technology adequately and appropriately reduces the risk of transmission of these relevant communicable disease agents (§ 1271.80(c)). The lists below are not complete. For additional CT/NG diagnostic tests meeting the regulations in § 1271.80(c), you may search the database at 510(k) Premarket Notification (fda.gov). For example, the term “Chlamydia” can be entered in the “Device Name” field to search for those tests.

C. trachomatis and N. gonorrhoeae NAT
(Detects C. trachomatis and N. gonorrhoeae DNA)

TradenameInfectious AgentFormatSpecimenUseManufacturerClearance DateSTN
Aptima Combo 2 AssayC. trachomatis, N. gonorrhoeaeTMALiving: 
Endocervical and vaginal swabs, male urethral swabs, swabs of extragenital sites (i.e. throat, rectum), female and male urine specimens
In Vitro qualitative detection rRNA from C. trachomatis and/or N. gonorrhoeae to aid in the diagnosis of chlamydial and/or gonococcal disease using the Panther® SystemHologic Inc.
San Diego, CA
6/13/2019K180681
Xpert CT/NG AssayC. trachomatis, N. gonorrhoeaePCRLiving: 
Endocervical and vaginal swabs, pharyngeal and rectal swabs, female and male urine specimens
In vitro qualitative detection and differentiation of DNA from C. trachomatis and/or N. gonorrhoeae to aid in the diagnosis of chlamydial and/or gonococcal disease using the GeneXpert Instrument SystemCepheid
Sunnyvale, CA
5/23/2019K190441
COBAS CT/NG AssayC. trachomatis, N. gonorrhoeaePCRLiving: 
Endocervical and vaginal swabs, female and male urine specimens, cervical specimens
In vitro qualitative detection of C. trachomatis and/or N. gonorrhoeae DNA to aid in the diagnosis of chlamydial and/or gonococcal disease using the cobas® 6800/8800 systemRoche Molecular Systems
Pleasanton, CA
3/21/2018K173887
Aptima Combo 2 Assay

CDRH Summary
C. trachomatis, N. gonorrhoeaeTMALiving: 
Endocervical and vaginal swabs, male urethral swabs, and urine specimens
In vitro qualitative assay for the detection and differentiation of ribosomal RNA (rRNA) from C. trachomatis and/or N. gonorrhoeae in specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal and/or chlamydial urogenital disease using the TIGRIS DTS Automated Analyzer or semi-automated instrumentation as specifiedGen-Probe, Inc.
San Diego, CA
8/9/2005K043224
BD ProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA AssaysC. trachomatis, N. gonorrhoeaeSDALiving: 
Endocervical swabs, male urethral swabs, urine specimens
In Vitro qualitative detection of C. trachomatis and N. gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in male and female urine specimens as evidence of infection with one or both organismsBecton, Dickinson & Co.
Sparks, MD
9/18/2001K012351

Chlamydia trachomatis

C. trachomatis NAT
(Detects C. trachomatis DNA)

TradenameInfectious AgentFormatSpecimenUseManufacturerClearance DateSTN
BD ProbeTec Chlamydia trachomatis (CT Q* amplified DNA assay)C. trachomatisSDALiving: 
Endocervical and vaginal swabs, male urethral swabs, and male and female urine specimens
Direct qualitative detection of C. trachomatisBecton, Dickinson & Co.
Sparks, MD
5/20/2014K140446
AMPLICOR CT/NG Test for Chlamydia trachomatisC. trachomatisPCRLiving: 
Endocervical swabs, male urethral swabs, urine specimens
In vitro qualitative in vitro test for the detection of C. trachomatis plasmid DNA to aid in the diagnosis of chlamydial diseaseRoche Diagnostics Corporation
Indianapolis, IN
4/16/2007K070174
Aptima Assay for Chlamydia trachomatisC. trachomatisTMALiving: 
Endocervical and vaginal swabs, male urethral swabs, and urine specimens
In vitro qualitative detection of C. trachomatis ribosomal RNA (rRNA) to aid in the diagnosis of chlamydial diseaseGen-Probe, Inc.
San Diego, CA
1/22/2007K063451

Neisseria gonorrhoeae

N. gonorrhoeae NAT
(Detects N. gonorrhoeae DNA)

TradenameInfectious AgentFormatSpecimenUseManufacturerClearance DateSTN
BD ProbeTec Neisseria gonorrhoeae (GC Q* amplified DNA assay)N. gonorrhoeaeSDALiving: 
Endocervical and vaginal swabs, male urethral swabs, and female and male urine specimens
Direct qualitative detection of N. gonorrhoeaeBecton, Dickinson & Co.
Sparks, MD
5/20/2014K140448
Amplicor CT/NG Test for Neisseria gonorrhoeaeN. gonorrhoeaePCRLiving: 
Endocervical and urethral swab
In vitro qualitative in vitro test for the detection of N. gonorrhoeae DNA to aid in the diagnosis of chlamydial diseaseRoche Diagnostics Corporation
Indianapolis, IN
4/17/2007K070172
Aptima Assay for Neisseria gonorrhoeaeN. gonorrhoeaeTMALiving: 
Endocervical and vaginal swabs, male urethral swabs, and urine specimens
In vitro qualitative detection of ribosomal RNA (rRNA) from N. gonorrhoeae to aid in the diagnosis of gonococcal urogenital diseaseGen-Probe, Inc.
San Diego, CA
1/25/2007K063664
COBAS AMPLICOR test for Neisseria gonorrhoeaeN. gonorrhoeaePCRLiving: 
Endocervical swabs, male urethral swabs, urine specimens
In vitro qualitative detection of N. gonorrhoeae in clinical specimens. The test is intended for use with the COBAS AMPLICOR Analyzer (K964506)Roche Molecular Systems
Somerville, NJ
5/28/1999K974342

Cleared Donor Screening Tests for Cytomegalovirus

Cytomegalovirus (CMV)

Note: The following CMV donor screening assays detect total antibody (IgG + IgM) to CMV. Though CMV is not a relevant communicable disease agent or disease, you must test a specimen from donors of viable, leukocyte-rich HCT/Ps for evidence of infection due to CMV, to adequately and appropriately reduce the risk of transmission (§ 1271.85(b)(2)). You must establish and maintain a standard operating procedure governing the release of an HCT/P from a donor whose specimen tests reactive for CMV (§ 1271.85(b)(2)). A reactive CMV antibody test does not necessarily make a donor ineligible.

Anti-CMV Assays

(Detects antibodies to CMV)
*Duplicate trade names may appear in table below due to updates to the assay.

Tradename*Infectious AgentFormatSpecimenUseManufacturerClearance DateSTN
Elecsys Anti-CMV; PreciControl Anti-CMV; PreciControl Release Anti-CMVCMVECLIALiving: 
Plasma, Serum
Donor Screening: Qualitative detection of antibodies to CMVRoche Diagnostics Indianapolis, IN US License 230511/3/2023BK230840
Capture-CMVCMVSolid phase red cell adherenceLiving: 
Plasma, Serum
Donor Screening: Qualitative detection of IgG and IgM antibodies to CMVImmucor, Inc.
Norcross, GA
2/8/2021BK200542
PK CMV-PA SystemCMVPassive particle agglutinationLiving: 
Plasma, Serum
Donor Screening: Qualitative detection of IgG and IgM antibodies to CMVFujirebio Diagnostics, Inc.
Malvern, PA
10/19/2020BK200476
Capture-CMVCMVSolid phase red cell adherenceLiving: 
Plasma, Serum
Donor Screening: Qualitative detection of IgG and IgM antibodies to CMVImmucor, Inc.
Norcross, GA
11/20/2018BK180247
Olympus PK CMV-PA SystemCMVPassive particle agglutinationLiving: 
Plasma, Serum
Donor Screening: Qualitative detection of IgG and IgM antibodies to CMVFujirebio Diagnostics, Inc.
Malvern, PA
9/20/2007BK070030
Abbott CMV Total AB EIACMVEIALiving: 
Plasma, Serum
Donor Screening: detection of antibodies to CMVAbbott Laboratories
Abbott Park, IL
03/24/1997K954301
BD CMV scan Card TestCMVLatex AgglutinationLiving: 
Plasma, Serum
Donor Screening: Qualitative detection of IgM and IgG antibodies to CMVBecton, Dickinson & Company
Franklin Lakes, NJ
12/22/1995BK950068
Capture-CMVCMVSolid phase red cell adherenceLiving: 
Plasma, Serum
Donor Screening: Qualitative detection of IgG and IgM antibodies to CMVImmucor, Inc.
Norcross, GA
12/22/1995BK950029

Cleared Donor Screening Tests for  Treponema pallidum

Treponema pallidum (T. pallidum)

Note: T. pallidum is the etiologic agent of syphilis. You may determine to be eligible a donor whose specimen tests negative or nonreactive on a non-treponemal screening test for syphilis. Under § 1271.80(d)(1), you may also determine to be eligible a donor whose specimen tests positive or reactive on a non-treponemal screening test for syphilis and negative or nonreactive on a specific treponemal confirmatory test, so long as all other required testing and screening are negative or nonreactive. A donor whose specimen tests positive or reactive on either a specific treponemal confirmatory test for syphilis or on a treponemal screening test is not eligible.

Specific Treponemal Confirmatory and Non-treponemal Screening Assays
(Detects antibodies to T. pallidum and other serological assays)

*Duplicate trade names may appear in table below due to updates to the assay.

Tradename*Infectious AgentFormatSpecimenUseManufacturerClearance DateSTN
Elecsys Syphilis; PreciControl Syphilis; PreciControl Release SyphilisT. pallidumSerology (Treponemal)Living:
Serum and Plasma
Donor Screening:    Qualitative detection of IgG and IgM antibodies to T. pallidumRoche Diagnostics Indianapolis, IN7/31/2023BK230839
ASI Automated RPR test for Syphilis for use on the ASI EvolutionT. pallidumRapid Plasma Reagin (RPR) Test
RPR (Non-treponemal)
Living: 
Plasma, Serum
Cadaveric:
Plasma, Serum
Donor Screening: Qualitative detection of reagin antibodiesArlington Scientific, Inc.
Springville, UT
2/2/2021BK200539
ASI Automated RPR test for Syphilis for use on the ASI EvolutionT. pallidumRapid Plasma Reagin (RPR) Test
RPR (Non-treponemal)
Living: 
Plasma, Serum
Donor Screening: Qualitative detection of reagin antibodiesArlington Scientific, Inc. Springville, UT9/30/2020BK200488
PK7400 TP HA Controls and PK7400 TP HA ReagentT. pallidumHemagglutination
(Treponemal)
Living: 
Plasma, Serum
Donor Screening: detection of IgG and IgM antibodies to T. pallidumNewmarket Biomedical, Ltd.
United Kingdom
8/1/2019BK180301
ASiManager-AT™T. pallidumRapid Plasma Reagin (RPR) Test
RPR (Non-treponemal)
Living: 
Plasma, Serum
Cadaveric: Plasma, Serum
Donor Screening: Qualitative detection of reagin antibodiesArlington Scientific, Inc.
Springville, UT
2/19/2015BK140192
TPHA ScreenT. pallidumHemagglutination
(Treponemal)
Living: 
Plasma, Serum
Donor Screening: Qualitative detection of IgG and IgM antibodies to T. pallidumImmucor, Inc.
Norcross, GA
10/24/2012BK120021
Olympus PK TP SystemT. pallidumMicro-hemagglutination
(Treponemal)
Living: 
Plasma, Serum
Donor Screening: Qualitative detection of IgG and IgM antibodies to T. pallidumFujirebio Diagnostics Inc.
Malvern, PA
2/21/2003BK030007
ASI TPHA TestT. pallidumMicro-hemagglutination
(Treponemal)
Living: 
Serum
Donor Screening: Qualitative detection of IgG and IgM antibodies to T. pallidumArlington Scientific, Inc.
Springville, UT
1/30/2003BK020031
CAPTIA Syphilis (T. Pallidum)-GT. pallidumEIA
(Treponemal)
Living: 
Plasma, Serum
Donor Screening: Qualitative detection of IgG antibodies to T. pallidumTrinity Biotech
Wicklow, Ireland
01/24/2002K014233

 

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