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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(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
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 NumberS003
Date Received06/17/1996
Decision Date08/22/1996
Reclassified Date 06/23/2014
Product Code MWA 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGING THE PACKAGE INSERT FOR THE MTD KIT TO INCLUDE AN ADDITIONAL WARNING AND AN EXPANDED LIMITATION REGARDIGN LOW POSITIVE RESULTS WITH MOTT.
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