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: Alere DetermineTM HIV-1/2 Ag/Ab Combo
• 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: Abbott Diagnostics Scarborough, Inc.; 10 southgate road; Scarborough , ME 04074
• PMA Number: BP120037
• Supplement Number: S007
• Date Received: 12/09/2015
• Decision Date: 03/04/2016

• Decision: Approved
• Product Code: QSU [ Registered Establishments with QSU ]
• Advisory Committee: Microbiology
• Supplement Type: Real Time Process
• Expedited Review Granted?: No
• Third Party Review Elligble?: No
• Combination Product: No