PMA P180047S039

Device: LIAISON QuantiFERON TB Gold Plus II; LIAISON Control QuantiFERON TB Gold Plus II
Applicant: DiaSorin, Inc.
PMA number: P180047
Supplement: S039
Product code: NCD
Decision date: 2026-01-26
Classification: Microbiology
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement: Approval for changes to the formulation of antibody and buffer reagents, changes to the assay component layout, changes to the assay protocol, introduction of the new trade name LIAISON QuantiFERON - TB Gold Plus II, LIAISON Control QuantiFERON - TB Gold Plus II, the addition of new suppliers for raw materials, and revisions to packaging and device labeling.

Current openFDA PMA Record#

Device: LIAISON QuantiFERON TB Gold Plus II; LIAISON Control QuantiFERON TB Gold Plus II
Applicant: DiaSorin, Inc.
PMA number: P180047
Supplement: S039
Product code: NCD
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date: 2026-01-26
Decision code: APPR
Date received: 2025-07-30
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for changes to the formulation of antibody and buffer reagents, changes to the assay component layout, changes to the assay protocol, introduction of the new trade name LIAISON QuantiFERON - TB Gold Plus II, LIAISON Control QuantiFERON - TB Gold Plus II, the addition of new suppliers for raw materials, and revisions to packaging and device labeling.