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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 TAQMAN 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 Drive
Pleasanton, CA 94588-2722
PMA NumberP060030
Supplement NumberS005
Date Received09/15/2009
Decision Date10/13/2009
Reclassified Date 12/22/2021
Product Code MZP 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
INCREASE IN THE MAXIMUM BULK BATCH SIZE FOR THE LOW POSITIVE CONTROL AND THE HIGH POSITIVE CONTROLS AND TO ELIMINATE REDUNDANT IN-PROCESS TESTING USED IN THE PREPARATION OF THE LOW AND HIGH POSITIVE CONTROLS.
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