PMA P180047S037

Device: LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus
Applicant: DiaSorin, Inc.
PMA number: P180047
Supplement: S037
Product code: NCD
Decision date: 2025-10-10
Classification: Microbiology
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement: Approval for the use of an alternative polypropylene resin for production of the plastic vials hosting the LIAISON assays reagents

Current openFDA PMA Record#

Device: LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus
Applicant: DiaSorin, Inc.
PMA number: P180047
Supplement: S037
Product code: NCD
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date: 2025-10-10
Decision code: APPR
Date received: 2025-07-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the use of an alternative polypropylene resin for production of the plastic vials hosting the LIAISON assays reagents