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    Randox Science Park

    Randox Science Park
    30 Randalstown Rd
    Antrim
    BT41 4FL
    United Kingdom
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    Certificate number: MD 686778
    Scope: The design, development, manufacture, service, installation and distribution of in-vitro diagnostic medical devices, invitro diagnostic test kits, in-vitro diagnostic reagents, calibrators and controls used in the diagnosis and management of cancer, diagnosis of immune status, disease status and autoimmune status, and the identifications 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. The design, development, manufacture, service, installation and distribution of in-vitro diagnostic analysers.

    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, manufacture, service, installation and distribution of in-vitro diagnostic medical devices, invitro 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, 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. The design, development, manufacture, service, installation and distribution of in-vitro diagnostic analysers.

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