Bio-Rad Geenius HIV-1/HIV-2 Supplemental Assay HIV PCR Plasma/Serum 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 by donor screening assay. Bio-Rad Laboratories
Redmond, WA
US License 1109 8/26/2019 BL125670 VioOne HIV Profile Supplemental Assay   HIV ELISA Plasma/Serum In vitro Diagnostic: 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. Avioq Inc., Research Triangle Park, NC 10/19/2020 BP180279 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 INSTI HIV-1/HIV-2 Antibody Test HIV-1 and HIV-2 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
  1/28/2015 BP090032/7 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.

Use of ADVIA Centaur XPT System

Use of Atellica IM Analyzer

Siemens Healthcare Diagnostics, Inc.

5/18/2006

11/15/2016

10/4/2018

BP050030

BP140103/2

BP140103/8

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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