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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOBAS AMPLICOR HCV TEST V2.0,COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
Generic NameAssay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Regulation Number866.3170
ApplicantRoche Molecular Systems, Inc.
4300 HACIENDA DR.
PLEASANTON, CA 94588-0900
PMA NumberP000012
Supplement NumberS042
Date Received05/21/2013
Decision Date06/07/2013
Withdrawal Date 08/26/2016
Product Code MZP 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO UPDATE THE SPECIFICATIONS FOR RECEIVING ACCEPTANCE OF A SUPPLIER¿S MATERIAL USED IN THE DEVICE.
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