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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)
Classification Namesystem, nucleic acid amplification, mycobacterium tuberculosis complex
Generic Namearget amplification test for the direct detection of mycobacterium tuberculosis
Regulation Number866.3372
ApplicantGEN-PROBE, INC.
PMA NumberP940034
Supplement NumberS001
Date Received02/23/1996
Decision Date04/23/1996
Product Code
MWA[ Registered Establishments with MWA ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1)a component (nalc) in a liquid reagent (enzyme dilution buffer) is moved to a lyophilized reagent (enzyme reagent), resulting in a stability shelf life of 1 year for the reagents and 1 year for the kit; 2) add an additional vendor of reverse transcriptase; and, 3) insignificant changes to the package insert.
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