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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 FOR USE WITH THE HIGH PURE SYSTEM
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 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 - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE TO THE BULK TESTING REQUIREMENTS FOR POSITIVE CONTROL REAGENTS.
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