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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 NameAMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST
Classification Namesystem, nucleic acid amplification, mycobacterium tuberculosis complex
Generic Namemycobacterium tuberculosis test
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP940040
Supplement NumberS010
Date Received11/05/2008
Decision Date11/25/2008
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 
Replacement of tetrazole, an activator used in the automated dna synthesis of rms oligonucleotides use in the amplicor mycobacterium tuberculosis (mtb) test with the activator 4,5 dicyanoimidazole (dci).
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