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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 NumberS018
Date Received03/31/2010
Decision Date04/23/2010
Product Code
MWA[ Registered Establishments with MWA ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change of location for a qc lab to segregate the pre- and post-amplification steps into separate rooms.