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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 NameROCHE AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST
Classification Namesystem, nucleic acid amplification, mycobacterium tuberculosis complex
Generic Namemycobacterium tuberculosis test
Regulation Number866.3372
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP940040
Supplement NumberS001
Date Received07/26/2000
Decision Date09/12/2000
Product Code
MWA[ Registered Establishments with MWA ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for current facility plans, revised batch records, revised qc specifications, revised packaging orders and revised labels.
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