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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement.
 
Device Roche Amplicor HIV-1 Monitor (tm) Test
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 NumberS037
Date Received11/07/2007
Decision Date04/29/2008
Decision Approved
Product Code
QUM[ Registered Establishments with QUM ]
Advisory Committee Clinical Chemistry
Supplement TypeSpecial Supplement
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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