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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 NumberS012
Date Received03/16/2007
Decision Date11/28/2007
Product Code
NCD[ Registered Establishments with NCD ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at celestis limited, victoria, australia for the bulk formulation of peptides.
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