PMA P180047S017
- Device
- LIAISON® QuantiFERON TB-Gold Plus assay and Control
- Applicant
- DiaSorin, Inc.
- PMA number
- P180047
- Supplement
- S017
- Product code
- NCD
- Decision date
- 2022-07-08
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- Approval for a software version change to the LIAISON XS Software.
Current openFDA PMA Record#
- Device
- LIAISON® QuantiFERON TB-Gold Plus assay and Control
- Applicant
- DiaSorin, Inc.
- PMA number
- P180047
- Supplement
- S017
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2022-07-08
- Decision code
- APPR
- Date received
- 2022-04-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a software version change to the LIAISON XS Software.