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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
Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton, CA 94588-2722
PMA NumberP050028
Supplement NumberS007
Date Received01/08/2010
Decision Date02/04/2010
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 
ELIMINATION OF IN-PROCESS CHEMICAL TESTING OF A BUFFER CONCENTRATE USED TO PREPARE THE MASTER MIX COMPONENT OF THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM.
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