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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002