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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 NumberS008
Date Received08/27/2012
Decision Date09/05/2012
Product Code OJN 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A DESIGN CHANGE, FOR A LARGER REAGENT VOLUME FORMAT FORTHE T-CELL XTEND REAGENT, AN ACCESSORY TO THE T-SPOT TB TEST, TO INCREASE THE VOLUME FROM 3 X 2ML VIALS IN A PACK TO A 50ML BOTTLE.
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