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FDA- Approved Tests for HIV
Antibody to Human Immunodeficiency Virus (HIV-1 Antigen Assay)
Tradename(s) Format Sample Use Manufacturer Approval Date
Abbott HIVAG-1 Monoclonal EIA Serum / Plasma Donor Screen / Prognosis & Neut. Kit Abbott Laboratories
Abbott Park, IL
US License 0043 		4/23/1996
Coulter HIV-1 p24 Ag Assay;
HIV-1 p24 Antigen ELISA Test System 		EIA Serum / Plasma Donor Screen / Prognosis & Neut. Kit Coulter Corporation
Miami, FL
US License 1185 		3/14/1996
Abbott HIVAG-1 EIA Serum / Plasma Prognosis & Neut. Kit Abbott Laboratories 8/3/1989
Coulter HIV-1 p24 Ag Assay EIA Viral Culture Supernatant Prognosis (Quantitative) & Neut. Kit Coulter Corporation 3/14/1996

Anti-HIV-1 Oral Specimen Collection Device
Tradename(s) Format Sample Use Manufacturer Approval Date
Epitope OraSure HIV-1 Oral Specimen Collection Device Oral Specimen Collection Device Oral Fluid For Use in Designated Non-Donor Screen and Non-Donor Supplemental Assays Epitope, Inc.
Beaverton, OR 		5/9/1991

Anti-HIV-1 Testing Service
Tradename(s) Format Sample Use Manufacturer Approval Date
Home Access HIV-1 Test System Dried Blood Spot Collection Device Dried Blood Spot Non-Donor Screen Home Access Health Corp.
Hoffman Estates, IL 		7/22/1996

Human Immunodeficiency Virus Type 1 (Anti-HIV-1 Assay)
Tradename(s) Format Sample Use Manufacturer Approval Date
HIVAB HIV-1 EIA EIA Serum / Plasma Donor Screen Abbott Laboratories
Abbott Park, IL
US License 0043 		3/1/1985
Genetic Systems rLAV EIA EIA Serum / Plasma Donor Screen Bio-Rad Laboratories Blood Virus Division
Redmond, WA
US License 1109 		6/29/1998
Murex SUDS HIV-1 Test Rapid EIA Serum / Plasma Donor Screen Murex Diagnostics, Inc.
Norcross, GA
US License 1152 		5/22/1992
Vironostika HIV-1 Microelisa System EIA Serum / Plasma Donor Screen Organon Teknika Corp.
Durham, NC
US License 0956 		12/18/1987
Novapath HIV-1 Immunoblot WB Serum / Plasma Donor Supplemental Bio-Rad Laboratories
Hercules, CA
US License 1109 		6/15/1990
Cambridge Biotech HIV-1 Western Blot Kit WB Serum / Plasma Donor Supplemental Calypte Biomedical Corp.
Berkeley, CA
US License 1207 		1/3/1991
Genetic Systems HIV-1 Western Blot WB Serum / Plasma Donor Supplemental Bio-Rad Laboratories Blood Virus Division 11/13/1998
EPIblot HIV-1 WB Serum / Plasma Donor Supplemental Epitope, Inc.
Beaverton, OR
US License 1133 		3/20/1991
Fluorognost HIV-1 IFA IFA Serum / Plasma Donor Supplemental Waldheim Pharmazeutika G.m.b.H.
Vienna, Austria
US License 1150 		2/5/1992
HIVAB HIV-1 EIA EIA Dried Blood Spot Non-Donor Screen Abbott Laboratories 4/22/1992
HIV-1 Urine EIA EIA Urine Screen Non-Donor Screen Calypte Biomedical Corp. 8/6/1996
Genetic Systems rLAV EIA EIA Dried Blood Spot Non-Donor Screen Bio-Rad Laboratories Blood Virus Division 6/29/1998
Vironostika HIV-1 Microelisa System EIA Dried Blood Spot Non-Donor Screen Organon Teknika Corp. 4/11/1990
Oral Fluid Vironostika HIV-1 Microelisa System EIA Oral Fluid Non-Donor Screen Organon Teknika Corp. 12/23/1994
Cambridge Biotech HIV-1 Western Blot Kit WB Urine Non-Donor Supplemental Calypte Biomedical Corp. 5/28/1998
Genetic Systems HIV-1 Western Blot WB Dried Blood Spot Non-Donor Supplemental Bio-Rad Laboratories Blood Virus Division 11/13/1998
OraSure HIV-1 Western Blot Kit WB Oral Fluid Non-Donor Supplemental Epitope, Inc. 6/3/1996
Fluorognost HIV-1 IFA IFA Dried Blood Spot Non-Donor Supplemental Waldheim Pharmazeutika G.m.b.H. 5/14/1996

Human Immunodeficiency Virus Types 1 & 2 (Anti-HIV-1/2 Assay)
Tradename(s) Format Sample Use Manufacturer Approval Date
Abbott HIVAB HIV-1/HIV-2 (rDNA) EIA EIA Serum / Plasma Donor Screen Abbott Laboratories
Abbott Park, IL
US License 0043 		2/14/1992
Genetic Systems HIV-1/HIV-2 Peptide EIA EIA Serum / Plasma / Cadaveric Serum Donor Screen Bio-Rad Laboratories Blood Virus Division
Redmond, WA
US License 1109 		12/9/2000

Human Immunodeficiency Virus Type 2 (Anti-HIV-2 Assay)
Tradename(s) Format Sample Use Manufacturer Approval Date
Genetic Systems HIV-2 EIA EIA Serum / Plasma Donor Screen Bio-Rad Laboratories Blood Virus Division
Redmond, WA
US License 1109 		4/25/1990

Human T-Lymphotropic Virus Types I & II (Anti-HTLV-I/II Assay)
Tradename(s) Format Sample Use Manufacturer Approval Date
Abbott HTLV-I/HTLV-II EIA EIA Serum / Plasma Donor Screen Abbott Laboratories
Abbott Park, IL
US License 0043 		8/15/1997
Vironostika HTLV-I/II Microelisa System EIA Serum / Plasma Donor Screen Organon Teknika Corp.
Durham, NC
US License 0956 		1/17/1998

Source
US Food and Drug Administration (FDA)
 

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