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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.
 
DeviceROCHE COBAS TAQMAN HBV TESTS
Generic NameHepatitis Viral B DNA Detection
Regulation Number866.3174
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton, CA 94588
PMA NumberP050028
Supplement NumberS020
Date Received07/01/2011
Decision Date03/20/2012
Reclassified Date10/20/2025
Product Code MKT 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO YOUR ASSAY INSTRUMENTATION AND SOFTWARE PLATFORM COLLECTIVELY REFERRED TO AS THE CAP/CTM SECOND GENERATION SYSTEM.
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