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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. 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 cobas HIV-1
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.
Pleasanton,  , CA  94588  -2722
PMA NumberBP150262
Supplement NumberS044
Date Received02/07/2020
Decision Date02/26/2020
Decision 30-Day Notice - No 135-Day Supplement Needed
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 ProductNo
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