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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 IN-TUBE
Classification Nametest, immunity, cell mediated, mycobacterium tuberculosis
ApplicantCELLESTIS INC
PMA NumberP010033
Supplement NumberS016
Date Received07/27/2010
Decision Date12/17/2010
Product Code
NCD[ Registered Establishments with NCD ]
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to relocate the peptide formulation for the blood collection tubes from australia to the usa facility in california.
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