T-SPOT.TB Test
FDA premarket approval P070006/S017 · decided 2021-07-26
Approval details
- PMA number
- P070006
- Supplement
- S017
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2021-05-03
- Decision date
- 2021-07-26
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- Approval to include an additional manufacturing site establishment to perform manufacturing of the device.
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