PMA P180047S021

Device: LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software
Applicant: DiaSorin, Inc.
Product code: NCD
Decision date: 2023-02-01
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement: Approval for a new system configuration featuring internal canisters for the supply of liquids (System Liquid, Wash Buffer, Cleaning solution) and changing from LIAISON XS software version 1.4.9 to software version 1.5.2, in order to support the new hardware components.

Current openFDA PMA Record#

Device: LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software
Applicant: DiaSorin, Inc.
PMA number: P180047
Supplement: S021
Product code: NCD
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date: 2023-02-01
Decision code: APPR
Date received: 2022-11-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a new system configuration featuring internal canisters for the supply of liquids (System Liquid, Wash Buffer, Cleaning solution) and changing from LIAISON XS software version 1.4.9 to software version 1.5.2, in order to support the new hardware components.