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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® HBV Test, v2.0
Generic NameHepatitis Viral B DNA Detection
Regulation Number866.3174
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton, CA 94588
PMA NumberP050028
Supplement NumberS089
Date Received12/01/2023
Decision Date12/14/2023
Reclassified Date10/20/2025
Product Code MKT 
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  
to eliminate an in-process test determined to be unnecessary
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