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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
Classification Nametest, immunity, cell mediated, mycobacterium tuberculosis
ApplicantCELLESTIS LIMITED
PMA NumberP010033
Supplement NumberS002
Date Received12/02/2002
Decision Date12/17/2002
Product Code
NCD[ Registered Establishments with NCD ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the substrate reagent used in the kit from a two-solution substrate system to a one-solution substrate system.
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