T-SPOT. TB TEST
FDA premarket approval P070006/S020 · decided 2023-12-12
Approval details
- PMA number
- P070006
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- 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
- 2023-05-26
- Decision date
- 2023-12-12
- Days to decision
- 200 days
- Decision code
- APPR
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- Approval for the use of a new pair of recombinant mouse monoclonal IgG anti-human IFN-gamma antibodies manufactured by an additional third paty supplier (Absolute Antibody Ltd.) with the T-SPOT.TB test kit
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