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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
Regulation Number866.3372
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP940040
Supplement NumberS003
Date Received04/07/2004
Decision Date04/22/2004
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 to the manufacturing process of the device to incorporate a terminal 0. 2um filtration step to the avidin-horseradish peroxidase (hrp) bgg conjugate reagent manufacturing process to ensure the removal of adventitious agents remaining in the reagent following formulation.
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