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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 NumberS005
Date Received04/06/2011
Decision Date05/04/2011
Product Code OJN 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF A SECOND APPROVED SUPPLIER OF ANTIBODY COATED PLATES FOR THE DEVICE.
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