Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Device: OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
• Classification Name: point of care hiv serology diagnostic and/or supplemental test
• Generic Name: point of care hiv serology diagnostic and/or supplemental test
• Regulation Number: 866.3956
• Applicant: OraSure Technologies, Inc; 150 webster street; Bethlehem , PA 18015 -1389
• PMA Number: BP010047
• Supplement Number: S074
• Date Received: 08/16/2017
• Decision Date: 09/13/2017

• Decision: 30-Day Notice - No 135-Day Supplement Needed
• Product Code: QSU [ Registered Establishments with QSU ]
• Advisory Committee: Microbiology
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Third Party Review Elligble?: No
• Combination Product: No