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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 NumberS005
Date Received07/02/1997
Decision Date01/07/1998
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 physician prescribing information to be considered a component of the labeling for mtd. At this time there are no provisions for "in vitro" device labeling other than prescribed 21 cfr 809. 10 (b); however, the physician prescribing information may be used as promotional and advertising material.
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