PMA P070006S018

Device: T-SPOT.TB Test
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S018
Product code: OJN
Decision date: 2023-03-20
Classification: Microbiology
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Approval order statement: Approval for [the inclusion of the Allsheng Auto-Pure (AP) 20B and Auto-Pure (AP) 24 for use with the T-Cell Select in the preparation of specimens for use with the T-SPOT.TB test

Current openFDA PMA Record#

Device: T-SPOT.TB Test
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S018
Product code: OJN
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Decision date: 2023-03-20
Decision code: APPR
Date received: 2022-12-21
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for [the inclusion of the Allsheng Auto-Pure (AP) 20B and Auto-Pure (AP) 24 for use with the T-Cell Select in the preparation of specimens for use with the T-SPOT.TB test