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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.
 
DeviceAMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST
Generic Namesystem, nucleic acid amplification, mycobacterium tuberculosis complex
Regulation Number866.3372
ApplicantRoche Molecular Systems, Inc.
4300 hacienda dr.
pleasanton, CA 94588-0900
PMA NumberP940040
Supplement NumberS003
Date Received04/07/2004
Decision Date04/22/2004
Withdrawal Date 09/06/2013
Product Code MWA 
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO THE MANUFACTURING PROCESS OF THE DEVICE TO INCORPORATE A TERMINAL 0.2UM FILTRATION STEP TO THE AVIDIN-HORSERADISH PEROXIDASE (HRP) BGG CONJUGATE REAGENT MANUFACTURING PROCESS TO ENSURE THE REMOVAL OF ADVENTITIOUS AGENTS REMAINING IN THE REAGENT FOLLOWING FORMULATION.
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