- Device
- LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software
- Applicant
- DiaSorin, Inc.
- PMA number
- P180047
- Supplement
- S020
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2022-12-21
- Decision code
- APPR
- Date received
- 2022-09-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software version 4.2.3.2 on the LIAISON XL analyzer.