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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.
Classification Namesystem, nucleic acid amplification, mycobacterium tuberculosis complex
Generic Namesystem, nucleic acid amplification, mycobacterium tuberculosis complex
Regulation Number866.3372
10210 genetic center dr.
san diego, CA 92121
PMA NumberP940034
Supplement NumberS005
Date Received07/02/1997
Decision Date01/07/1998
Product Code
MWA[ Registered Establishments with MWA ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for physician prescribing information to be considered a component of the labeling for mtd. At this time there are no provisions for "in vitro" device labeling other than prescribed 21 cfr 809. 10 (b); however, the physician prescribing information may be used as promotional and advertising material.