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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
Roche Molecular Systems, Inc.
4300 hacienda dr.
pleasanton, CA 94588-0900
PMA NumberP940040
Supplement NumberS005
Date Received03/08/2005
Decision Date04/22/2005
Product Code
MWA[ Registered Establishments with MWA ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at roche molecular systems, inc. , sommerville, new jersey, for kit packaging and staging activities.