Vaccines, Blood & Biologics
OraQuick Rapid HIV-1/2 Antibody Test
Applicant: OraSure Technologies, Bethlehem, PA
Product: OraQuick Rapid HIV-1/2 Antibody Test
PMA number: BP010047
Approval Date: 3/26/2004
PMA number: BP010047/10
Indication for Use: Allow for an added labeling claim for the detection of antibodies to HIV-1 and HIV-2 in plasma specimens and the detection of HIV-1 antibodies in oral fluid specimen.
March 26, 2004 Approval Letter
Subject Information (PDF - 257 KB)
Approval Date: 3/19/2004
PMA number: BP010047/12
Indication for Use: Addition to the intended use statement to include detection of antibodies to HIV-2.
March 19, 2004 Approval Letter
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