T-SPOT.TB Test
FDA premarket approval P070006/S028 · decided 2025-08-04
Approval details
- PMA number
- P070006
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- T-SPOT.TB Test
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Applicant
- Oxford Immunotec, Ltd.
- Date received
- 2025-07-07
- Decision date
- 2025-08-04
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- a supplier increase in manufacturing scale
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