- Device
- LIAISON QuantiFERON - TB Gold Plus, LIAISON XL Control QuantiFERON - TB Gold Plus
- Applicant
- DiaSorin, Inc.
- PMA number
- P180047
- Supplement
- S032
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2025-04-25
- Decision code
- APPR
- Date received
- 2025-01-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change from the LIAISON XL software version 4.2.3.3SP1 to software version 4.2.4.4.