- Device
- LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test
- Applicant
- DiaSorin, Inc.
- PMA number
- P190017
- Supplement
- S008
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2022-12-21
- Decision code
- APPR
- Date received
- 2022-09-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software version 4.2.3.2 on the LIAISON XL analyzer.