An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Approved Blood Products

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

Supporting Documents

Supporting Documents older than three years - VERSANT HIV-1 RNA 3.0 Assay (bDNA)

Top