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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 may have changed. Be sure to look at the supplements 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 Namearget amplification test for the direct detection of mycobacterium tuberculosis
ApplicantGEN-PROBE, INC.
PMA NumberP940034
Date Received07/11/1994
Decision Date12/15/1995
Product Code
MWA[ Registered Establishments with MWA ]
Docket Number 97M-0184
Notice Date 06/18/1997
Advisory Committee Microbiology
Expedited Review Granted? Yes
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S015 S016 S017 S018 S019 
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