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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 TAQMAN HBV TEST
Classification Namehepatitis viral b dna detection
Generic Namehepatitis viral b dna detection
Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton, CA 94588-2722
PMA NumberP050028
Supplement NumberS051
Date Received04/18/2016
Decision Date05/13/2016
Product Code
MKT[ Registered Establishments with MKT ]
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 
Addition of a new filler system and transfer of the microtube filling operations of controls to a new laboratory.
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