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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 NameAMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST
Classification Namesystem, nucleic acid amplification, mycobacterium tuberculosis complex
ApplicantGEN-PROBE, INC.
PMA NumberP940034
Supplement NumberS018
Date Received03/31/2010
Decision Date04/23/2010
Product Code
MWA[ Registered Establishments with MWA ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change of location for a qc lab to segregate the pre- and post-amplification steps into separate rooms.
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