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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 TEST)
Classification Namesystem, nucleic acid amplification, mycobacterium tuberculosis complex
ApplicantGEN-PROBE, INC.
PMA NumberP940034
Supplement NumberS013
Date Received12/18/2001
Decision Date01/25/2002
Product Code
MWA[ Registered Establishments with MWA ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the relative light units (rlu) specification for the 0. 2-0. 3 mm washed glass beads (part no. 101321) and filled lysing tubes (part no. 102606).
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