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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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
Date Received07/11/1994
Decision Date12/15/1995
Reclassified Date 06/23/2014
Product Code MWA 
Docket Number 97M-0184
Notice Date 06/18/1997
Advisory Committee Microbiology
Expedited Review Granted? Yes
Combination ProductNo
Supplements:  S018 S009 S010 S011 S017 S016 S013 S005 S006 S015 S012 
S019 S004 S002 S003 S001 S007 S008 
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