PMA P070006S012

Device: T-SPOT. TB Test
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S012
Product code: OJN
Decision date: 2020-03-03
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Approval order 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.

Current openFDA PMA Record#

Device: T-SPOT. TB Test
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S012
Product code: OJN
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Decision date: 2020-03-03
Decision code: APPR
Date received: 2019-12-05
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.