T-SPOT.TB Test
FDA premarket approval P070006/S018 · decided 2023-03-20
Approval details
- PMA number
- P070006
- Supplement
- S018
- 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
- 2022-12-21
- Decision date
- 2023-03-20
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- Approval for [the inclusion of the Allsheng Auto-Pure (AP) 20B and Auto-Pure (AP) 24 for use with the T-Cell Select in the preparation of specimens for use with the T-SPOT.TB test
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