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: Abbott RealTime HIV-1 Amplification Reagent Kit; Abbott RealTime HIV-1 Calibrator Kit; Abbott RealTime HIV-1 Control Kit
• Classification Name: human immunodeficiency virus (hiv) viral load monitoring test
• Generic Name: human immunodeficiency virus (hiv) viral load monitoring test
• Regulation Number: 866.3958
• Applicant: Abbott Molecular; 1300 e. touhy avenue; Des Plaines , IL 60018
• PMA Number: BP060002
• Supplement Number: S009
• Date Received: 12/06/2007
• Decision Date: 05/30/2008

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