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 | S003 |
Date Received | 10/01/2009 |
Decision Date | 03/04/2010 |
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 THE INSTITUTION OF THE USE OF SEMI-AUTOMATED SYSTEM FOR THE DISPENSING AND CAPPING STAGES IN THE PRODUCTION OF THE POSITIVE CONTROL, PANEL A REAGENT, AND PANEL B REAGENT OF THE T-SPOT.TB TEST KIT USING THE FF30 DISPENSER/CAPPER FROM FLEXICON. IN ADDITION, THE TYPE OF VIAL CAPS HAS BEEN CHANGED FROM A POPCAN CAP TO A HDPE CAP WHICH IS NOW GAMMA IRRADIATED RATHER THAN AUTOCLAVED TO REDUCE BACTERIAL AND FUNGAL CONTAMINATION. |
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