PMA P190017S028
- Device
- LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual
- Applicant
- DiaSorin, Inc.
- PMA number
- P190017
- Supplement
- S028
- Product code
- LOM
- Decision date
- 2025-08-28
- Classification
- Microbiology
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- to add another packaging line in one of DiaSorin’s locations
Current openFDA PMA Record#
- Device
- LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual
- Applicant
- DiaSorin, Inc.
- PMA number
- P190017
- Supplement
- S028
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2025-08-28
- Decision code
- OK30
- Date received
- 2025-08-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add another packaging line in one of DiaSorin’s locations