Applicant: OraSure Technologies, Inc, Bethlehem, PA
Product: OraQuick Rapid HIV-1 Antibody Test
PMA number: BP010047
Approval Date: 9/5/2003
Indication for Use: Allow for a labeling claim for the detection of antibodies to HIV-1 in venipuncture whole blood specimens and to reduce the maximum read time from 60 minutes to 40 minutes.