PMA P070006S027

Device: T-SPOT.TB TEST
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S027
Product code: OJN
Decision date: 2025-08-04
Classification: Microbiology
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Approval order statement: Approval for three changes to the T-Cell Select reagent kit: to change the concentration of one antibody reagent, to add an alternative supplier of both antibody reagents, and to extend the open container shelf life.

Current openFDA PMA Record#

Device: T-SPOT.TB TEST
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S027
Product code: OJN
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Decision date: 2025-08-04
Decision code: APPR
Date received: 2025-05-02
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for three changes to the T-Cell Select reagent kit: to change the concentration of one antibody reagent, to add an alternative supplier of both antibody reagents, and to extend the open container shelf life.