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.
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.