T SPOT-TB Test
FDA premarket approval P070006/S014 · decided 2020-08-11
Approval details
- PMA number
- P070006
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- 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
- 2020-03-30
- Decision date
- 2020-08-11
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- Approval for change to the age limitation in the current T-SPOT.TB test labeling to allow use of the test in individuals 2 years of age and older.
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