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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceT-SPOT. TB Test
Generic NameMycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
ApplicantOxford Immunotec, Ltd.
94c Innovation Dr.
Milton Park, Abingdon Oxfordshire OX14 4RZ
PMA NumberP070006
Supplement NumberS012
Date Received12/05/2019
Decision Date03/03/2020
Product Code OJN 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for extension of the shelf life of the T-SPOT.TB50 kit, including Panel A, Panel B, and Positive Control, from 12 months to 18 months.
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