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 | S004 |
Date Received | 02/18/2010 |
Decision Date | 03/19/2010 |
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 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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