T-SPOT TB TEST
FDA premarket approval P070006/S007 · decided 2011-11-23
Approval details
- PMA number
- P070006
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- T-SPOT TB TEST
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Applicant
- Oxford Immunotec, Ltd.
- Date received
- 2011-11-17
- Decision date
- 2011-11-23
- Days to decision
- 6 days
- Decision code
- APPR
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- APPROVAL FOR THE ADDITION OF A NEW TEST KIT FORMAT WITH INCREASED REAGENT VOLUMES AND 50 ANTIBODY COATED 96-WELL MICROTITRE PLATES TO INCREASE THE KIT CAPACITY TO A TOTAL OF 1200 TESTS.
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