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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 NameAMPLICOR HCV TEST V2.0
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Generic Nameroche amplicor hepatitis c virus (hcv) test version 2.0
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP000010
Supplement NumberS022
Date Received05/31/2011
Decision Date12/29/2011
Product Code
MZP[ Registered Establishments with MZP ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at roche molecular systems, inc. In somerville, new jersey.
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