Applicant: OraSure Technologies, Bethlehem, PA
Product: OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
PMA number: BP010047 / 16
Indication for Use: Added labeling claim for the detection of HIV-2 antibodies in oral fluid and a change in the name of the device to OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
Approval Date: 6/22/2004

Letter - (Text)

Label - (PDF)

Summary - (PDF)

Control Kit - (PDF)

Subject Information - (PDF)