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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 HCV
Classification Nameassay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Generic Nameassay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton, CA 94588-2722
PMA NumberP150015
Supplement NumberS031
Date Received05/09/2019
Decision Date06/06/2019
Product Code
MZP[ Registered Establishments with MZP ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Scale up for manufacturing of a sub-bulk reagent and subsequent changes to filling operations for a critical component.
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