510(k) DEN250032
DEN250032 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)". The FDA issued a decision of De Novo Granted on December 23, 2025. The device falls under product code SGW (Device To Detect Antibodies To Hepatitis D Virus), a Class II device regulated under 21 CFR 866.3176. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 23, 2025
- Date Received
- July 30, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device To Detect Antibodies To Hepatitis D Virus
- Device Class
- Class II
- Regulation Number
- 866.3176
- Review Panel
- MI
- Submission Type
The device to detect antibodies to hepatitis D Virus is an in vitro diagnostic device intended for prescription use for the detection of antibodies to the hepatitis D virus (anti-HDV) in human clinical specimens. The assay is intended as an aid in the diagnosis of HDV infection in individuals who are at risk for HDV infection. The assay is intended as an aid in diagnosis in conjunction with clinical findings and other diagnostic procedures. The assay is not intended for screening of blood, plasma, cells, or tissue donors.