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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
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 NumberP150015
Supplement NumberS039
Date Received07/24/2020
Decision Date11/02/2020
Reclassified Date 12/22/2021
Product Code MZP 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
changes to the cobas HBV Assay Specific Analytical Package (ASAP) software for use with the cobas HBV test (P150014) and cobas HCV ASAP software for use with the cobas HCV test (P150015) for use with the cobas 6800/8800
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