| Atellica® IM HIV Ag/Ab Combo (CHIV) |
HIV-1/2 |
in vitro qualitative detection test |
Serum, Plasma |
in vitro diagnostic test for the simultaneous qualitative detection of human immunodeficiency virus p24 antigen and antibodies to human immunodeficiency viruses type 1 (including group “O”) and type 2, in serum and plasma using the Atellica CI Analyzer. |
Siemens Healthcare Diagnostics, Inc. |
11/7/2024 |
BK241075 |
| 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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