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: Bio-Rad Geenius HIV 1/2 Supplemental Assay
• 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: Bio-Rad Laboratories, Inc.; 6565 185th avenue ne; Redmond , WA 98052
• PMA Number: BP140120
• Supplement Number: S008
• Date Received: 07/18/2017
• Decision Date: 08/15/2017

• 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