- Device
- LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus
- Applicant
- DiaSorin, Inc.
- PMA number
- P220034
- Supplement
- S004
- Product code
- MYL
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Decision date
- 2025-04-25
- Decision code
- APPR
- Date received
- 2025-01-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change from the LIAISON XL software version 4.2.3.3SP1 to software version 4.2.4.4.