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Vaccines, Blood & Biologics
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HIV-1
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Nucleic Acid Testing
- Roche Amplicor HIV-1 Monitor Test
Roche Molecular Systems, Inc - NucliSens HIV-1 QT
bioMerieux, Inc - COBAS AmpliScreen HIV-1 Test
Roche Molecular Systems - Procleix HIV-1/HCV Assay
Gen-Probe, Inc - UltraQual HIV-1 RT-PCR Assay
National Genetics Institute - ViroSeq HIV-1 Genotyping System with the 3700 Genetic Analyzer
Celera Diagnostics - VERSANT HIV-1 RNA 3.0 Assay (bDNA)
Bayer Corporation - APTIMA HIV-1 RNA Qualitative Assay
- Procleix Ultrio Assay
Gen-Probe, Inc - Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) Assay
Manufacturer: BioLife Plasma Services, L.P. - Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit
ABBOTT Molecular, Inc - COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L
Roche Molecular Systems, Inc - COBAS TaqScreen MPX Test
Roche Molecular Systems, Inc
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Human Immunodeficiency Virus Type 1 (Anti-HIV-1 Assay)
- Avioq HIV-1 Microelisa System
Avoiq Inc. - Genetic Systems rLAV EIA
Manufacturer: Bio-Rad Laboratories - Cambridge Biotech HIV-1 Western Blot Kit
Manufacturer: Maxim Biomedical, Inc - OraSure HIV-1 Western Blot Kit
Epitope, Inc - MedMira Reveal Rapid HIV-1 Antibody Test
MedMira Laboratories, Inc - Trinity Biotech Uni-Gold Recombigen HIV Uni-Gold Recombigen HIV Positive and Negative Controls
Trinity Biotech plc
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Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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