BEUDAMED
    Eu Ivdr Eu Ivd Class A On The Market 🇺🇸 United States

    NOVEOS® Immunoassay System

    Hycor Biomedical LLC · 🇺🇸 United States
    View on EUDAMED
    Devices (same UDI-DI)
    2
    Certificates
    0
    Countries
    8
    Notified Bodies
    0

    Basic Information

    Primary DI
    00816879022995
    Basic UDI-DI Code
    081687902NOVINST37
    Reference
    63000
    Device Types
    None provided
    Regulation
    Eu Ivdr
    Classification
    Eu Ivd Class A
    Status
    On The Market
    Manufacturer
    Hycor Biomedical LLC

    Additional Description

    The NOVEOS® Immunoassay System is an in vitro diagnostic medical device used, in combination with NOVEOS® Software and accessories, for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. It is an automated device to be used by professional users in a clinical laboratory setting.

    CND Nomenclature Codes

    Code Description
    W0201020192 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
    W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)

    Available In Countries

    🇧🇪 Belgium 🇩🇪 Germany 🇬🇷 Greece 🇪🇸 Spain 🇫🇷 France 🇱🇺 Luxembourg 🇳🇱 Netherlands 🇹🇷 Türkiye

    Related Devices

    The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

    NOVEOS flex Immunoassay System

    Device
    EU IVDR · Eu Ivd Class A ·Hycor Biomedical LLC·On the market·8 countries

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