PMA P180047S019

Device: LIAISON QuantiFERON-TB Gold Plus
Applicant: DiaSorin, Inc.
Product code: NCD
Decision date: 2023-07-18
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement: Approval for a change in the conjugate reagent in the LIAISON QuantiFERON TB Gold Plus assay from a lyophilized format to a liquid format.

Current openFDA PMA Record#

Device: LIAISON QuantiFERON-TB Gold Plus
Applicant: DiaSorin, Inc.
PMA number: P180047
Supplement: S019
Product code: NCD
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date: 2023-07-18
Decision code: APPR
Date received: 2022-08-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change in the conjugate reagent in the LIAISON QuantiFERON TB Gold Plus assay from a lyophilized format to a liquid format.