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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 NumberS010
Date Received02/14/2006
Decision Date03/10/2006
Product Code
NCD[ Registered Establishments with NCD ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for lableing change to the wording of the interpretation of the test to remove ambiguity and enhance safe use.
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