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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 NameQUANTIFERON-TB GOLD IN-TUBE
Classification Nametest, immunity, cell mediated, mycobacterium tuberculosis
ApplicantCELLESTIS INC
PMA NumberP010033
Supplement NumberS017
Date Received08/30/2010
Decision Date05/26/2011
Product Code
NCD[ Registered Establishments with NCD ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revisions to the device package insert and marketing booklet subsequent to the publication ofthe cdc's updated guidelines for using interferon gamma release assays to detect mycobacterium tuberculosis infection - united states, 2010, in accordance with the original pma post-approval requirement.
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