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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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New Search Biologics Premarket Approvals (PMAs) Back to Search Results
Note: this medical device record is a supplement.
 
Device AMPLICOR® HIV-1 MONITOR Test, v1.5; COBAS® AMPLICOR® HIV-1 MONITOR Test, v1.5; COBAS® AmpliPrep/COBAS® AMPLICOR® HIV-1 MONITOR Test, v1.5
Classification Namehuman immunodeficiency virus (hiv) viral load monitoring test
Generic Namehuman immunodeficiency virus (hiv) viral load monitoring test
Regulation Number866.3958
Applicant
Roche Molecular Systems, Inc.
1080 us highway 202
Branchburg, Somerville , NJ 08876 -3771
PMA NumberBP950005
Supplement NumberS058
Date Received12/12/2011
Decision Date10/26/2012
Decision Approved
Product Code
QUM[ Registered Establishments with QUM ]
Advisory Committee Clinical Chemistry
Supplement Type135 Day Track for 30 Day Notification
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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