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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(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
ApplicantGEN-PROBE, INC.
PMA NumberP940034
Supplement NumberS011
Date Received10/25/2000
Decision Date11/21/2000
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the enzyme dilution buffer and tentatie reconstituted stability (pending completion of real-time studies) of the enzyme reagent for 30 days with an added precaution, and other minor changes to the labeling (including clarification of control testing procedures).
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