T-SPOT. TB Test
FDA premarket approval P070006/S012 · decided 2020-03-03
Approval details
- PMA number
- P070006
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- T-SPOT. TB Test
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Applicant
- Oxford Immunotec, Ltd.
- Date received
- 2019-12-05
- Decision date
- 2020-03-03
- 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 extension of the shelf life of the T-SPOT.TB50 kit, including Panel A, Panel B, and Positive Control, from 12 months to 18 months.
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