510(k) DEN250032
- Device
- LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)
- Applicant
- DiaSorin, Inc.
- 510(k) number
- DEN250032
- Product code
- SGW
- Decision
- Unknown (DENG)
- Decision date
- 2025-12-23
- Date received
- 2025-07-30
- Regulation
- 866.3176
- Classification name
- Device To Detect Antibodies To Hepatitis D Virus
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Kerrie Oetter
- Address
- 1951 Northwestern Ave. Stillwater MN US 55082 55082
FDA Registration Numbers
- 9610240
- 2243471
Source Documents
510(k) summary PDF not indicated by FDA