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Vaccines, Blood & Biologics
VERSANT HIV-1 RNA 3.0 Assay (bDNA)
Product: VERSANT HIV-1 RNA 3.0 Assay (bDNA)
Applicant: Bayer Corporation, Berkeley, CA
PMA number: BP000028/0
Indication for Use: for the direct quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in plasma of HIV-1 infected individuals
Approval Date: 9/11/2002
Letter - (PDF - 169 KB)
Summary - (PDF - 2 MB)
Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Consumer Affairs Branch (CBER)
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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