T-SPOT. TB Test
FDA premarket approval P070006/S015 · decided 2022-08-29
Approval details
- PMA number
- P070006
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- T-SPOT. TB Test
- Applicant
- Oxford Immunotec, Ltd.
- Date received
- 2020-11-02
- Decision date
- 2022-08-29
- Days to decision
- 665 days
- Decision code
- APPR
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- Approval for the T-Cell Select kit. The device is intended for use with the T-SPOT.TB test for the isolation of mononuclear immune cells from whole blood stored at room temperature (18 25 °C), using positive selection via a magnetic bead-based cell separation system.
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