PMA P070006S015

Device: T-SPOT. TB Test
Applicant: Oxford Immunotec, Ltd.
Decision date: 2022-08-29
Approval order 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.

Current openFDA PMA Record#

Device: T-SPOT. TB Test
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S015
Decision date: 2022-08-29
Decision code: APPR
Date received: 2020-11-02
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.