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    Luminex Molecular Diagnostics, Inc.

    Luminex Molecular Diagnostics, Inc.
    439 University Avenue
    Toronto
    M5G 1Y8
    Canada
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    Certificate number: MD 800613
    Scope: Design, development, manufacture and distribution of microsphere-based and PCR-based reagents and assays used in the detection, diagnosis and/or management of nucleic acids related to hereditary diseases, drug metabolism and infectious diseases. Contract manufacturer of custom primer mixes for in vitro diagnostic use.

    Standard/Scheme number or name Start Date Expiry Date
    ISO 13485: 2016 2024-01-24 2027-06-21

    Certificate number: MDSAP 800622
    Scope: Design, development and manufacture of in-vitro diagnostic reagents, test kits and associated software used in the detection, diagnosis and/or management of nucleic acids related to hereditary diseases, drug metabolism and infectious diseases.

    Standard/Scheme number or name Start Date Expiry Date
    MDSAP 2024-01-12 2027-06-21