PMA P180039S010
- Device
- LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier
- Applicant
- DiaSorin, Inc.
- PMA number
- P180039
- Supplement
- S010
- Product code
- LOM
- Decision date
- 2022-05-06
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Introduce an additional supplier for an assay accessory.
Current openFDA PMA Record#
- Device
- LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier
- Applicant
- DiaSorin, Inc.
- PMA number
- P180039
- Supplement
- S010
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2022-05-06
- Decision code
- OK30
- Date received
- 2022-04-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce an additional supplier for an assay accessory.