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 | S013 |
Date Received | 03/10/2020 |
Decision Date | 04/03/2020 |
Product Code |
OJN |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of an alternative nonsterile raw material. |
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