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: S011
• Date Received: 07/09/2019
• Decision Date: 09/10/2019

• Decision: Approved
• Product Code: QSU [ Registered Establishments with QSU ]
• Advisory Committee: Microbiology
• Supplement Type: Normal 180 Day Track
• Expedited Review Granted?: No
• Third Party Review Elligble?: No
• Combination Product: No