- Device
- LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus
- Applicant
- DiaSorin, Inc.
- PMA number
- P180047
- Supplement
- S009
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2021-11-16
- Decision code
- APPR
- Date received
- 2021-04-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for migration of the LIAISON QuantiFERON-TB Gold Plus and LIAISON Control QuantiFERON-TB Gold Plus to an additional analyzer platform LIAISON XS.