DEN250032
- 510(k) number
- DEN250032
- Device name
- LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)
- Applicant
- DiaSorin, Inc. MN · US
- Product code
- SGW — Device To Detect Antibodies To Hepatitis D Virus
- Decision date
- 2025-12-23
- Date received
- 2025-07-30
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Immunology
Official FDA record: DEN250032
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.