PMA P180038S002
- Device
- LIAISON XL MUREX Anti-HBc
- Applicant
- DiaSorin, Inc.
- PMA number
- P180038
- Supplement
- S002
- Product code
- LOM
- Decision date
- 2020-08-06
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Approval for software version change to the LIAISON XL analyzer software.
Current openFDA PMA Record#
- Device
- LIAISON XL MUREX Anti-HBc
- Applicant
- DiaSorin, Inc.
- PMA number
- P180038
- Supplement
- S002
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2020-08-06
- Decision code
- APPR
- Date received
- 2020-06-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software version change to the LIAISON XL analyzer software.