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    Randox Laboratories Ltd

    Randox Laboratories Ltd
    61 Largy Road
    Crumlin
    BT29 4RR
    United Kingdom
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    Certificate number: MD 686778
    Scope: The design, development and manufacture of in-vitro diagnostic medical devices, in-vitro diagnostic test kits, in-vitro diagnostic reagents, calibrators and controls used in diagnosis and management of cancer, diagnosis of immune status, disease status and autoimmune status, cardiac markers, protein metabolism, endocrine disorders, transmissible agents, sexually transmissible agents, fertility and for immunological typing and therapeutic drug monitoring. The design, development, manufacture and distribution of companion diagnostics.

    Standard/Scheme number or name Start Date Expiry Date
    ISO 13485: 2016 2018-03-19 2028-11-05

    Certificate number: MDSAP 699499
    Scope: The design, development and manufacture of in-vitro diagnostic medical devices, in-vitro diagnostic test kits, in-vitro diagnostic reagents, calibrators and controls used in diagnosis and management of cancer, diagnosis of immune status, disease status and autoimmune status, cardiac markers, protein metabolism, endocrine disorders, transmissible agents, sexually transmissible agents, fertility and for immunological typing and therapeutic drug monitoring. The design, development, manufacture and distribution of companion diagnostics.

    Standard/Scheme number or name Start Date Expiry Date
    MDSAP 2019-11-06 2028-11-05