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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 AMPLICOR HCV TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP000012
Supplement NumberS005
Date Received03/08/2005
Decision Date04/22/2005
Product Code
MZP[ Registered Establishments with MZP ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at roche molecular systems, inc. , sommerville, new jersey, for kit packaging and staging activities.
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