- Device
- LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus
- Applicant
- DiaSorin, Inc.
- PMA number
- P180047
- Supplement
- S011
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2022-01-21
- Decision code
- APPR
- Date received
- 2021-11-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to allow an additional supplier of reaction cuvettes used with the assays on the LIAISON XL Analyzer.