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  • Certified Management System

    • Management Systems

      EN ISO 13485

    • Certificate Holder

      Chembio Diagnostics GmbH

    • Test Mark Number


    The certificate holder's Management System corresponds to standard EN ISO 13485:2016.

    Certificate scope

    • EN ISO 13485

      Design and development, manufacture and distribution of instruments used in combination with in vitro diagnostic lateral flow assays

    Certificate for this Management System

    Contact to the certificate holder

    Chembio Diagnostics GmbH

    Schwarzschildstr. 1
    12489 Berlin