PMA P180047S014

Device: LIAISON® QuantiFERON TB-Gold Plus assay and Control
Applicant: DiaSorin, Inc.
PMA number: P180047
Supplement: S014
Product code: NCD
Decision date: 2022-05-05
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement: Approval to allow the LIAISON XL Analyzer to be connected to the Beckman DxA 5000, an FDA-cleared third party Laboratory Automation System (LAS).

Current openFDA PMA Record#

Device: LIAISON® QuantiFERON TB-Gold Plus assay and Control
Applicant: DiaSorin, Inc.
PMA number: P180047
Supplement: S014
Product code: NCD
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date: 2022-05-05
Decision code: APPR
Date received: 2022-02-04
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to allow the LIAISON XL Analyzer to be connected to the Beckman DxA 5000, an FDA-cleared third party Laboratory Automation System (LAS).