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    ISO 13485: 2016

    Randox Laboratories Limited
    55 Diamond Road
    Crumlin
    County Antrim
    BT29 4QY
    United Kingdom
    BSI logo

    Certificate Number: MD 686778
    Scope: The design, development, manufacture, service, installation and distribution of in-vitro diagnostic medical devices, in-vitro diagnostic test kits, in-vitro diagnostic reagents, calibrators and controls and in-vitro diagnostic analysers used in diagnosis and management of cancer, diagnosis of immune status, disease status and autoimmune status, and the identification of drugs of abuse, cardiac markers, protein metabolism, endocrine disorders, blood analytes, blood components, blood gases, coagulation, transmissible agents, sexually transmissible agents, fertility and for immunological typing and therapeutic drug monitoring. The design, development, manufacture and distribution of companion diagnostics.

    Original Registration Date Effective Date Last Revision Date Expiry Date
    2018-03-19 2025-11-06 2026-07-21 2028-11-05