BEUDAMED
    Eu Ivdr Eu Ivd Class C On The Market 🇨🇳 China

    SCCA CLIA Microparticles

    Autobio Diagnostics Co., Ltd. · 🇨🇳 China
    View on EUDAMED
    Devices (same UDI-DI)
    4
    Certificates
    0
    Countries
    3
    Notified Bodies
    0

    Basic Information

    Primary DI
    06942359517065
    Basic UDI-DI Code
    697015090000014GT
    Reference
    CMB1307
    Device Types
    None provided
    Regulation
    Eu Ivdr
    Classification
    Eu Ivd Class C
    Status
    On The Market
    Manufacturer
    Autobio Diagnostics Co., Ltd.

    Additional Description

    The SCCA CLIA Microparticles assay and AutoLumo SCCA Calibrators are used together based on the fully automated chemiluminescent microparticle immunoassay (CLIA Microparticles) system for the quantitative determination of SCCA (squamous cell carcinoma antigen) in human serum. Clinical determination of SCCA is used as for dynamic monitoring of patients, which acts as an aid of disease progression or treatment determination of squamous cell carcinoma.

    CND Nomenclature Codes

    Code Description
    W0102030116 SQUAMOUS CELL CARCINOMA ANTIGEN

    Available In Countries

    🇮🇹 Italy 🇷🇴 Romania 🇹🇷 Türkiye

    Related Devices

    The Basic UDI-DI associated with this device has 4 devices in total. Below are some other devices sharing the same Basic UDI-DI.

    AutoLumo SCCA Calibrators

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    EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

    AutoLumo SCCA Calibrators

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    EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

    SCCA CLIA Microparticles

    Device
    EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

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