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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
Classification Nametest, immunity, cell mediated, mycobacterium tuberculosis
ApplicantCELLESTIS INC
PMA NumberP010033
Supplement NumberS019
Date Received08/04/2011
Decision Date10/20/2011
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 changes to the labeling: instructions for use section, specimen collection and handling section, and abbreviated test procedure section for use of the quantiferon® blood collection tubes.
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