PMA P070006S023

Device: T-SPOT.TB Test
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S023
Product code: OJN
Decision date: 2024-06-04
Classification: Microbiology
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Approval order statement: Approval for the use of in-house manufactured micro-well plates and the use of two alternative micro-well plate membranes in the manufacture of the T-SPOT.TB Test.

Current openFDA PMA Record#

Device: T-SPOT.TB Test
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S023
Product code: OJN
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Decision date: 2024-06-04
Decision code: APPR
Date received: 2024-03-06
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the use of in-house manufactured micro-well plates and the use of two alternative micro-well plate membranes in the manufacture of the T-SPOT.TB Test.