meddevicedb.com FDA Device Reference

LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)

DEN250032 Class II Direct
Decision Date
2025-12-23
Sponsor / Applicant
DiaSorin, Inc.

Technical Specification

510(k) Submission ID DEN250032
Product Code SGW
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.3176
Decision Date 2025-12-23
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) received FDA 510(k) clearance under submission number DEN250032, sponsored by DiaSorin, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2025-12-23.

Classification & Regulation

This clearance is catalogued under FDA product code SGW and 21 CFR 866.3176, within the Immunology review panel as a Class II device.