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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 NameGEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
Classification Namesystem, nucleic acid amplification, mycobacterium tuberculosis complex
Generic Nametarget amplification test for the direct detection of mycobacterium tuberculosis
Regulation Number866.3372
ApplicantGEN-PROBE, INC.
PMA NumberP940034
Supplement NumberS003
Date Received06/17/1996
Decision Date08/22/1996
Product Code
MWA[ Registered Establishments with MWA ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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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