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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 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
PMA NumberP000012
Supplement NumberS034
Date Received09/01/2011
Decision Date09/29/2011
Withdrawal Date08/26/2016
Product Code MZP 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE REVISION OF THE PACKAGE INSERT FOR THE COBAS AMPIPREP/COBAS AMPLICOR HCV TEST, V2.0.
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