T-SPOT .TB TEST
FDA premarket approval P070006/S006 · decided 2012-01-04
Approval details
- PMA number
- P070006
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- T-SPOT .TB TEST
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Applicant
- Oxford Immunotec, Ltd.
- Date received
- 2011-07-12
- Decision date
- 2012-01-04
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- APPROVAL FOR THE USE OF T-CELL XTEND REAGENT IN EXTENDING WHOLE BLOOD STORAGE FROM 0-32 HOURS PRIOR TO ASSAYING WITH THE T-SPOT.TB TEST.
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