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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 NumberS005
Date Received09/15/2009
Decision Date10/13/2009
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 
Increase in the maximum bulk batch size for the low positive control and the high positive controls and to eliminate redundant in-process testing used in the preparation of the low and high positive controls.
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