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    SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·January 2, 2019

    Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·August 30, 2023

    Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays on Clinical Chemistry and Immunoassay systems, Abbott Spectrum, Abbott Aeroset, Abbott Architect i2000, Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, AU800, AU600, AU400, AU2700, AU5400, Selectra Vitalab, Synchron CX4, Synchron CX5, Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira Plus systems

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·November 13, 2019

    Aerogen Ltd

    Manufacturer
    🇮🇪 Ireland·5 Basic UDI-DIs·5 Devices·National Standards Authority of Ireland (NSAI)

    Medifill Ltd

    Manufacturer
    🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·National Standards Authority of Ireland (NSAI)

    Incereb Ltd

    Manufacturer
    🇮🇪 Ireland·4 Basic UDI-DIs·6 Devices

    DentalOrganiser Ltd

    Manufacturer
    🇮🇪 Ireland

    phenox Ltd

    Manufacturer
    🇮🇪 Ireland

    Palliare Ltd

    Manufacturer
    🇮🇪 Ireland

    Rottapharm Ltd

    Manufacturer
    🇮🇪 Ireland·18 Basic UDI-DIs·18 Devices·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

    Ovelle Ltd

    Manufacturer
    🇮🇪 Ireland

    Vasorum Ltd.

    Manufacturer
    🇮🇪 Ireland

    Perfuze Ltd

    Manufacturer
    🇮🇪 Ireland

    Teleatherapy Ltd

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

    HiberGene Diagnostics Ltd

    Manufacturer
    🇮🇪 Ireland

    Class Medical Ltd.

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

    DMC Medical Ltd

    Manufacturer
    🇮🇪 Ireland

    Rehan Electronics Ltd

    Manufacturer
    🇮🇪 Ireland

    FastForm Research Ltd.

    Manufacturer
    🇮🇪 Ireland

    SteriPack Ireland Ltd

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