OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
PMA: BP010047
Proper Name: OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
Tradename: None
Manufacturer: OraSure Technologies
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
Product Information
- Label - OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
- Control Kit - OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
- Subject Information - OraQuick ADVANCE Rapid HIV-1/2 Antibody Test