PMA P180038S014
- Device
- LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control anti-HBc
- Applicant
- DiaSorin, Inc.
- PMA number
- P180038
- Supplement
- S014
- Product code
- LOM
- Decision date
- 2022-12-08
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Elimination of a manufacturing step for kit component.
Current openFDA PMA Record#
- Device
- LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control anti-HBc
- Applicant
- DiaSorin, Inc.
- PMA number
- P180038
- Supplement
- S014
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2022-12-08
- Decision code
- OK30
- Date received
- 2022-11-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Elimination of a manufacturing step for kit component.