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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.
 
Trade NameCOBAS AMPLIPREP/COBAS TAQMAN HCV TEST
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP060030
Supplement NumberS022
Date Received08/24/2011
Decision Date09/22/2011
Product Code
MZP[ Registered Establishments with MZP ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Revision of the in-process testing assay validation criteria for the positive control bulk materials used for the device.
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