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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 NumberS010
Date Received11/05/2008
Decision Date11/25/2008
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  
REPLACEMENT OF TETRAZOLE, AN ACTIVATOR USED IN THE AUTOMATED DNA SYNTHESIS OF RMS OLIGONUCLEOTIDES USE IN THE AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST WITH THE ACTIVATOR 4,5 DICYANOIMIDAZOLE (DCI).
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