PMA P180047S026

Device: LIAISON® QuantiFERON® - TB Gold Plus, LIAISON® XL Control QuantiFERON-TB Gold Plus
Applicant: DiaSorin, Inc.
PMA number: P180047
Supplement: S026
Product code: NCD
Decision date: 2024-07-12
Classification: Microbiology
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement: to change the cleaning process for equipment used to manufacture critical assay components

Current openFDA PMA Record#

Device: LIAISON® QuantiFERON® - TB Gold Plus, LIAISON® XL Control QuantiFERON-TB Gold Plus
Applicant: DiaSorin, Inc.
PMA number: P180047
Supplement: S026
Product code: NCD
Generic name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date: 2024-07-12
Decision code: OK30
Date received: 2024-06-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to change the cleaning process for equipment used to manufacture critical assay components