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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.
Classification Namesystem, nucleic acid amplification, mycobacterium tuberculosis complex
Generic Nametarget amplification test for the direct detection of mycobacterium tuberculosis
Regulation Number866.3372
ApplicantGEN-PROBE, INC.
PMA NumberP940034
Supplement NumberS002
Date Received05/22/1996
Decision Date06/05/1996
Product Code
MWA[ Registered Establishments with MWA ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing the package insert to include more details on adequate vortexing.