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: Orasure HIV-1 Oral Specimen Collection Device
• 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; 8505 sw creekside place; Beaverton , OR 97005
• PMA Number: BP910001
• Supplement Number: S035
• Date Received: 09/09/2021
• Decision Date: 10/04/2021

• 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