T-SPOT.TB TEST
FDA premarket approval P070006/S027 · decided 2025-08-04
Approval details
- PMA number
- P070006
- Supplement
- S027
- 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
- 2025-05-02
- Decision date
- 2025-08-04
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- Approval for three changes to the T-Cell Select reagent kit: to change the concentration of one antibody reagent, to add an alternative supplier of both antibody reagents, and to extend the open container shelf life.
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