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Vaccines, Blood & Biologics
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L
Applicant: Roche Molecular Systems, Inc
Product: COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests
COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L
PMA number: BP050069/0
Indication for Use: Quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid in human plasma for use in conjunction with clinical presentation and other laboratory markers
Approval Date: 5/11/2007
Summary of Safety and Effectiveness (PDF - 319 KB)
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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