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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 NumberS007
Date Received01/14/2004
Decision Date02/10/2004
Product Code
NCD[ Registered Establishments with NCD ]
Advisory Committee Microbiology
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the manufacturing process of the quantiferon-tb to allow the use of k-blue max substrate as an alternative substrate reagent to increase the shelf life of the kit to 3 years.
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