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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 NumberS003
Date Received02/20/2003
Decision Date03/17/2003
Product Code
NCD[ Registered Establishments with NCD ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the instructions for use that enhance the safe use of the quantiferon-tb by incorporating recommendations from the "cdc guidelines for using the quantiferon-tb test for diagnosing latent mycobacterium tuberculosis infection" (mmwr dispatch, vol. 51/december 18, 2002).
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