BEUDAMED
    Basic UDI-DI Eu Ivdd Eu Ivd Annex 2 List A 🇺🇸 United States

    OnSite HIV 1/2 Ab Plus Combo Rapid Test

    Code: B-00855402007771
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-00855402007771
    Issuing Agency
    EUDAMED
    Types
    Animal tissues Kit Professional testing
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Annex 2 List A
    Manufacturer
    CTK Biotech Inc.
    Last Updated
    June 13, 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    Expired / Withdrawn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) No.2020-IVD/QS-008 May 26, 2024

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    OnSite HIV 1/2 Ab Plus Combo Rapid Test On the market