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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameAMPLIFED MYCOBACTERIUM TUBERCULOSIS DIRECTOR (MTD) TEST
ApplicantGEN-PROBE, INC.
PMA NumberP940034
Supplement NumberS009
Date Received10/19/1998
Decision Date12/01/1998
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional text under warnings: "sediments prepared using alpha-tec systems, inc. Nac-pac(tm) xpr-plus(tm) a. F. B. Processing buffer have been shown to interfere with amplification. ".
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