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    Roche Molecular Systems, Inc.

    Roche Molecular Systems, Inc.
    1080 US Highway 202 South
    Branchburg
    08876
    USA
    BSI logo

    Certificate number: MDSAP 739944
    Scope: Manufacture, Warehouse, and Distribution. Quality and Complaint Management.

    Standard/Scheme number or name Start Date Expiry Date
    MDSAP 2018-07-01 2027-06-30

    Certificate number: MD 739945
    Scope: Design, manufacture, packaging, warehouse, and distribution of In Vitro Diagnostic Kits, integrated systems and associated software used in the diagnosis and management of disease status of infectious diseases, donor screening associated with infectious diseases, primary screening associated with oncogenic viruses, detection of biomarkers for companion diagnostics, microbiology, and genetic testing.

    Standard/Scheme number or name Start Date Expiry Date
    ISO 13485: 2016 2021-03-05 2027-06-30