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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 NumberS004
Date Received02/18/2010
Decision Date03/19/2010
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 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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