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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 TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM
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 NumberP060030
Supplement NumberS015
Date Received02/08/2011
Decision Date02/24/2011
Reclassified Date12/22/2021
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  
ELIMINATION OF THE IN-PROCESS CHEMICAL TESTING OF THE BUFFER CONCENTRATE COMPONENT OF THE MASTER MIX USED WITH THE COBAS TAQMAN HCV TEST, V2.0 WITHIN THE FDA APPROVED PCR MANUFACTURING CENTER (PMC) FACILITY IN BRANCHBURG, NEW JERSEY.
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