BEUDAMED
    Basic UDI-DI Eu Ivdd Eu Ivd General 🇺🇸 United States

    ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control

    Code: B-00816784020307
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-00816784020307
    Issuing Agency
    EUDAMED
    Device Model
    2015-0072
    Types
    Kit Human tissues Microbial substances Professional testing
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd General
    Manufacturer
    LGC Clinical Diagnostics, Inc.
    Last Updated
    March 14, 2023

    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) CE 572689 May 26, 2025

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control On the market