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    Check company, site and product certificates - Validation and Verification, UK and global companies

    Randox Laboratories Limited

    Randox Laboratories Limited
    36 Largy Road
    Crumlin
    BT29 4RN
    United Kingdom
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    Certificate number: MD 686778
    Scope: The design and development 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, 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 and development 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 and development 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, 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 and development of companion diagnostics.

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