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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 TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0
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 NumberS023
Date Received12/12/2011
Decision Date09/18/2012
Product Code
MKT[ Registered Establishments with MKT ]
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the manufacturing changes to the dna synthesizer instrument platform for the vialed master mix and probe reagent components.
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