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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 TEST FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0
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 NumberS024
Date Received03/29/2012
Decision Date06/07/2012
Product Code
MKT[ Registered Establishments with MKT ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., IN SOMERVILLE, NEW JERSEY.
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