PMA P070006S024

Device: T-SPOT TB
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S024
Product code: OJN
Decision date: 2025-03-31
Classification: Microbiology
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Approval order statement: Approval to include the Allsheng Auto-Pure (AP) 2400 liquid handling instrument with the T-Cell Select reagent kit to automate the isolation and dilution of Peripheral Blood Mononuclear Cells and preparation of assay plates for use with the T-SPOT.TB Test.

Current openFDA PMA Record#

Device: T-SPOT TB
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S024
Product code: OJN
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Decision date: 2025-03-31
Decision code: APPR
Date received: 2024-04-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to include the Allsheng Auto-Pure (AP) 2400 liquid handling instrument with the T-Cell Select reagent kit to automate the isolation and dilution of Peripheral Blood Mononuclear Cells and preparation of assay plates for use with the T-SPOT.TB Test.