T-SPOT TB
FDA premarket approval P070006/S024 · decided 2025-03-31
Approval details
- PMA number
- P070006
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- T-SPOT TB
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Applicant
- Oxford Immunotec, Ltd.
- Date received
- 2024-04-01
- Decision date
- 2025-03-31
- Days to decision
- 364 days
- Decision code
- APPR
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- Approval to include the Allsheng Auto-Pure (AP) 2400 liquid handling instrument with the T-Cell Select reagent kit to automate the isolation and dilution of Peripheral Blood Mononuclear Cells and preparation of assay plates for use with the T-SPOT.TB Test.
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