- Device
- LIAISON QuantiFERON-TB Gold Plus; LIAISON XL Control QuantiFERON-TB Gold Plus; LIAISON QuantiFERON-TB Gold Plus II; LIAI
- Applicant
- DiaSorin, Inc.
- PMA number
- P180047
- Supplement
- S043
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2026-08-27
- Decision code
- APPR
- Date received
- 2026-03-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the LIAISON diluteX as an accessory for use with the LIAISON XL analyzer with the LIAISON QuantiFERON-TB Gold Plus and LIAISON QuantiFERON-TB Gold Plus II assays