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    Certificate number: MD 686778
    Scope: The design, development, manufacture and distribution of in-vitro diagnostic analysers, manufacture of in-vitro diagnostic reagents, 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.

    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 and distribution of in-vitro diagnostic analysers, manufacture of in-vitro diagnostic reagents, 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.

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