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. |
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Device | T-SPOT .TB TEST |
Generic Name | Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test |
Applicant | OXFORD IMMUNOTEC,LTD. 94C INNOVATION DRIVE MILTON PARK, ABINGDON OXFORDSHIRE OX14 |
PMA Number | P070006 |
Supplement Number | S008 |
Date Received | 08/27/2012 |
Decision Date | 09/05/2012 |
Product Code |
OJN |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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