PMA P180045S005
- Device
- LIAISON® XL Murex HBc IgM and LIAISON® XL Murex Control HBc IgM
- Applicant
- DiaSorin, Inc.
- PMA number
- P180045
- Supplement
- S005
- Product code
- LOM
- Decision date
- 2021-12-27
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Changes allowing harmonization of product QC workflows.
Current openFDA PMA Record#
- Device
- LIAISON® XL Murex HBc IgM and LIAISON® XL Murex Control HBc IgM
- Applicant
- DiaSorin, Inc.
- PMA number
- P180045
- Supplement
- S005
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2021-12-27
- Decision code
- OK30
- Date received
- 2021-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes allowing harmonization of product QC workflows.