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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.
 
DeviceGEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD)
Generic NameSystem, nucleic acid amplification, mycobacterium tuberculosis complex
Regulation Number866.3372
ApplicantGEN-PROBE, INC.
10210 GENETIC CENTER DR.
SAN DIEGO, CA 92121
PMA NumberP940034
Supplement NumberS017
Date Received07/27/2006
Decision Date07/18/2007
Reclassified Date 06/23/2014
Product Code MWA 
Advisory Committee Microbiology
Supplement Type135 Review Track For 30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO A QUALITY CONTROL RELEASE SPECIFICATION FOR THE ENZYME REAGENT, A COMPONENT OF THE MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST.
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