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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 AND TB GOLD IN-TUBE
Classification Nametest, immunity, cell mediated, mycobacterium tuberculosis
ApplicantCELLESTIS INC
PMA NumberP010033
Supplement NumberS014
Date Received06/24/2009
Decision Date01/29/2010
Product Code
NCD[ Registered Establishments with NCD ]
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of the dry room at scantibodies laboratory, inc. , santee, california, to be used as an alternative method to vacuum drying in the manufacturing process of elisa plates.
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