BEUDAMED
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    Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·August 8, 2018

    Beckman Coulter Ireland Inc.

    Manufacturer
    🇮🇪 Ireland·78 Basic UDI-DIs·102 Devices

    Biotech Europe Meditech Inc Limited

    Manufacturer
    🇮🇪 Ireland·1 Basic UDI-DI·1 Device

    Beckman Coulter Ireland Inc.

    Authorized representative
    🇮🇪 Ireland·3 Manufacturers·1177 Devices

    Biotech Europe Meditech Inc Limited

    Authorized representative
    🇮🇪 Ireland·1 Manufacturer·5 Devices

    AQUIOS Flow-Count

    Device
    EU IVDR · Eu Ivd Class C ·Beckman Coulter Ireland Inc.·On the market·32 countries

    ISE Low Serum Standard

    Device
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·On the market·32 countries

    ISE High Serum Standard

    Device
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·On the market·32 countries

    ISE Internal Reference

    Device
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·On the market·32 countries

    ISE Low/High Urine Standard

    Device
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·On the market·32 countries

    ISE Na+/K+ Selectivity Check

    Device
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·On the market·32 countries

    Digoxin Calibrator

    Device
    EU IVDR · Eu Ivd Class C ·Beckman Coulter Ireland Inc.·On the market·32 countries

    Digoxin

    Device
    EU IVDR · Eu Ivd Class C ·Beckman Coulter Ireland Inc.·On the market·32 countries

    Digitoxin Calibrator

    Device
    EU IVDR · Eu Ivd Class C ·Beckman Coulter Ireland Inc.·On the market·32 countries

    Digitoxin

    Device
    EU IVDR · Eu Ivd Class C ·Beckman Coulter Ireland Inc.·On the market·32 countries

    ISE BUFFER

    Device
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·On the market·32 countries

    ISE MID STANDARD

    Device
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·On the market·32 countries

    ISE Reference

    Device
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·On the market·32 countries

    Myoglobin

    Device
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·On the market·32 countries

    Myoglobin

    Device
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·On the market·32 countries