Skip to contentDe Novo DEN250032
- Device
- LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)
- Contact
- kerrie oetter
- De Novo number
- DEN250032
- Product code
- SGW
- Regulation
- 866.3176
- Classification name
- device to detect antibodies to hepatitis d virus
- Decision
- granted (DENG)
- Decision date
- 2025-12-23
- Date received
- 2025-07-30
- Classification advisory
- Immunology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- SGW
- Device name
- Device To Detect Antibodies To Hepatitis D Virus
- Medical specialty
- Immunology
- Device class
- 2
- Regulation
- 866.3176
- Implant
- N
- Life sustain/support
- N