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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 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 NumberS025
Date Received05/30/2012
Decision Date06/29/2012
Product Code
MKT[ Registered Establishments with MKT ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to amplilink software v3. 3. 6.
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