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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? AmpliPrep/COBAS? TaqMan? HIV-1 Test, v 2.0 and; COBAS? TaqMan? HIV-1 Test v2.0 For Use With The High Pure System
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.
4300 hacienda drive
Pleasanton, , CA 94588 -2722
  
PMA NumberBP050069
Supplement NumberS082
Date Received07/17/2017
Decision Date08/07/2017
Decision 30-Day Notice - No 135-Day Supplement Needed
Product Code
QUM[ Registered Establishments with QUM ]
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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