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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 NumberS026
Date Received08/30/2010
Decision Date05/24/2011
Withdrawal Date08/26/2016
Product Code MZP 
Advisory Committee Microbiology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ELIMINATING AURINTRICARBOXYLIC ACID (ATA) ACTIVITY TESTING IN COBAS AMPLIPREP/ COBAS AMPLICOR HCV INTERNAL CONTROL BUFFER AND SPECIMEN DILUENT BULK SOLUTIONS.
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