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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCOBAS TAQMAN HBV FOR USE WITH THE HIGH PURE SYSTEM
Classification Namehepatitis viral b dna detection
Generic Namecobas taqman hbv test for use with the high pure system
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP050028
Supplement NumberS033
Date Received05/28/2013
Decision Date06/24/2013
Product Code
MKT[ Registered Establishments with MKT ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the bulk testing requirements for positive control reagents.
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