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    Check company, site and product certificates - Validation and Verification

    Roche Molecular Systems, Inc.

    Roche Molecular Systems, Inc.
    2 Millennium Way
    Branchburg
    08876
    USA
    BSI logo

    Certificate number: CE 707974
    Scope: Design and manufacture of nucleic acid test kits for Donor Screening for HBV, HCV and HIV. Design and manufacture of nucleic acid test kits to aid in the diagnosis and management of disease status for HBV, HCV or HIV infected individuals. Design and manufacture of nucleic acid test kits to aid in the diagnosis and management of Cytomegalovirus in transplant patients and for detection of HCV, HBV, HIV-1, HIV-2 and Chlamydia Trachomatis.

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV Ex. 4&6 (H7) 2019-03-26 2025-05-26

    Certificate number: MDSAP 739944
    Scope: Warehouse and Distribution.

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

    Certificate number: MD 739945
    Scope: Packaging, Warehouse and distribution

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