PMA P180047S016

Device: LIAISON® QuantiFERON TB-Gold Plus assay and Control
Applicant: DiaSorin, Inc.
PMA number: P180047
Supplement: S016
Product code: NCD
Decision date: 2022-06-23
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement: Approval for the addition of the alternate supplier, Balda Medical GmbH (Bad Oeynhausen, Germany), to produce vial and frame plastics components of the Reagent Integral.

Current openFDA PMA Record#

Device: LIAISON® QuantiFERON TB-Gold Plus assay and Control
Applicant: DiaSorin, Inc.
PMA number: P180047
Supplement: S016
Product code: NCD
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date: 2022-06-23
Decision code: APPR
Date received: 2022-04-05
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the addition of the alternate supplier, Balda Medical GmbH (Bad Oeynhausen, Germany), to produce vial and frame plastics components of the Reagent Integral.