PMA P180047S035

Device: LIAISON QuantiFERON -TB Gold Plus and LIAISON Control QuantiFERON -TB Gold Plus
Applicant: DiaSorin, Inc.
PMA number: P180047
Supplement: S035
Product code: NCD
Decision date: 2025-06-04
Classification: Microbiology
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement: Approval for additional Cuvettes supplier and the refinement of a few geometric tolerances of the cuvettes in bulk.

Current openFDA PMA Record#

Device: LIAISON QuantiFERON -TB Gold Plus and LIAISON Control QuantiFERON -TB Gold Plus
Applicant: DiaSorin, Inc.
PMA number: P180047
Supplement: S035
Product code: NCD
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date: 2025-06-04
Decision code: APPR
Date received: 2025-03-12
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for additional Cuvettes supplier and the refinement of a few geometric tolerances of the cuvettes in bulk.