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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
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton, CA 94588
PMA NumberP050028
Supplement NumberS016
Date Received03/01/2011
Decision Date03/22/2011
Reclassified Date10/20/2025
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  
DISCONTINUATION OF FINAL BULK TESTING REQUIREMENTS FOR BULK QUANTITATION STANDARD (QS) AND INTERNAL CONTROL (IC) REAGENTS FOR 17 QS/IC PRODUCTS USED WITH THE ASSOCIATED ASSAYS.
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