- Device
- LIAISON XL MUREX Anti-HBs, LIAISON XL MUREX Control Anti-HBs and LIAISON XL MUREX Anti-HBs Verifiers
- Applicant
- DiaSorin, Inc.
- PMA number
- P180039
- Supplement
- S004
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2021-08-10
- Decision code
- APPR
- Date received
- 2021-05-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a software version change for the LIAISON XL Analyzer from the approved LIAISON XL version 4.2.2.3 SP1 to software version 4.2.2.4.