Premarket Approval (PMA)

Note: this medical device record is a supplement.

• Device: Roche Amplicor HIV-1 Monitor (tm) Test
• 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: Roche Molecular Systems, Inc.; 1080 us highway 202; Branchburg, Somerville , NJ 08876 -3771
• PMA Number: BP950005
• Supplement Number: S018
• Date Received: 10/15/2004
• Decision Date: 11/04/2004

• Decision: Approved
• Product Code: QUM [ Registered Establishments with QUM ]
• Advisory Committee: Clinical Chemistry
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Third Party Review Elligble?: No
• Combination Product: No