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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 KIT
Classification Nametest, immunity, cell mediated, mycobacterium tuberculosis
ApplicantCELLESTIS LIMITED
PMA NumberP010033
Supplement NumberS005
Date Received04/18/2003
Decision Date05/12/2003
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 the supplier for phytohaemagglu-tinin (pha-p), which is used to formulate the mitogen component in the quantiferon-tb kit.
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