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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 AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD)
Classification Namesystem, nucleic acid amplification, mycobacterium tuberculosis complex
ApplicantGEN-PROBE, INC.
PMA NumberP940034
Supplement NumberS017
Date Received07/27/2006
Decision Date07/18/2007
Product Code
MWA[ Registered Establishments with MWA ]
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to a quality control release specification for the enzyme reagent, a component of the mycobacterium tuberculosis direct (mtd) test.
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