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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 HVC 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 NumberS025
Date Received08/27/2010
Decision Date09/23/2010
Withdrawal Date08/26/2016
Product Code MZP 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGES TO REDUCE THE BATCH SIZE FOR MANUFACTURE OF SUBSTRATE A, SUBATRATE B, STOP REAGENT AND WASH CONCENTRATE BULK SOLUTION.
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