PMA P070006S020

Device: T-SPOT. TB TEST
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S020
Product code: OJN
Decision date: 2023-12-12
Classification: Microbiology
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Approval order statement: Approval for the use of a new pair of recombinant mouse monoclonal IgG anti-human IFN-gamma antibodies manufactured by an additional third paty supplier (Absolute Antibody Ltd.) with the T-SPOT.TB test kit

Current openFDA PMA Record#

Device: T-SPOT. TB TEST
Applicant: Oxford Immunotec, Ltd.
PMA number: P070006
Supplement: S020
Product code: OJN
Generic name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
Decision date: 2023-12-12
Decision code: APPR
Date received: 2023-05-26
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the use of a new pair of recombinant mouse monoclonal IgG anti-human IFN-gamma antibodies manufactured by an additional third paty supplier (Absolute Antibody Ltd.) with the T-SPOT.TB test kit