PMA P180047S045

Device: LIAISON QuantiFERON-TB Gold III; LIAISON Control QuantiFERON-TB Gold III; LIAISON QuantiFERON-TB Gold Plus II; LIAISON C
Applicant: DiaSorin, Inc.
PMA number: P180047
Supplement: S045
Product code: NCD
Decision date: 2026-08-27
Classification: Microbiology
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement: Approval of the addition of a three-tube blood collection configuration of the assay, introduction of the trade name LIAISON QuantiFERON-TB Gold III, LIAISON Control QuantiFERON-TB Gold III, and associated revisions to result interpretation and labeling.

Current openFDA PMA Record#

Device: LIAISON QuantiFERON-TB Gold III; LIAISON Control QuantiFERON-TB Gold III; LIAISON QuantiFERON-TB Gold Plus II; LIAISON C
Applicant: DiaSorin, Inc.
PMA number: P180047
Supplement: S045
Product code: NCD
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date: 2026-08-27
Decision code: APPR
Date received: 2026-05-29
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval of the addition of a three-tube blood collection configuration of the assay, introduction of the trade name LIAISON QuantiFERON-TB Gold III, LIAISON Control QuantiFERON-TB Gold III, and associated revisions to result interpretation and labeling.