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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 NameT-SPOT .TB TEST
Classification Namemycobacterium tuberculosis, cell mediated immune response, enzyme-linked immunospot test
ApplicantOXFORD IMMUNOTEC,LTD.
PMA NumberP070006
Supplement NumberS004
Date Received02/22/2010
Decision Date03/19/2010
Product Code
OJN[ Registered Establishments with OJN ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an extra approved supplier (us biological, inc. ) of phytohemagglutinin and of another supplier (thermo fisher scientific gmbh) of antigen peptides (panels a and b) for the t-spot®. Tb kits.
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