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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.
Classification Namemycobacterium tuberculosis, cell mediated immune response, enzyme-linked immunospot test
PMA NumberP070006
Supplement NumberS003
Date Received11/16/2009
Decision Date03/04/2010
Product Code
OJN[ Registered Establishments with OJN ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the institution of the use of semi-automated system for the dispensing and capping stages in the production of the positive control, panel a reagent, and panel b reagent of the t-spot. Tb test kit using the ff30 dispenser/capper from flexicon. In addition, the type of vial caps has been changed from a popcan cap to a hdpe cap which is now gamma irradiated rather than autoclaved to reduce bacterial and fungal contamination.