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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
Generic Namecobas taqman hbv test for use with the high pure system
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP050028
Supplement NumberS015
Date Received03/01/2011
Decision Date07/12/2012
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 a change in the manufacturing process of bulk capg gnr wash reagent.
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