510(k) DEN250032

LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) by DiaSorin, Inc. — Product Code SGW

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.

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