T-SPOT.TB Test
FDA premarket approval P070006/S023 · decided 2024-06-04
Approval details
- PMA number
- P070006
- Supplement
- S023
- Supplement type
- Real-Time Process
- 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
- 2024-03-06
- Decision date
- 2024-06-04
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- Approval for the use of in-house manufactured micro-well plates and the use of two alternative micro-well plate membranes in the manufacture of the T-SPOT.TB Test.
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