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    ISO 13485:2016

    Zhejiang DiSigns Diagnostics Technology
    Co., Ltd.
    First Floor, Building 2, Block A and B
    No.321 Jinpeng Street
    Hangzhou
    Xihu District
    310030
    China
    BSI logo

    Certificate Number: MD 704947
    Scope: Design, development and manufacture of in vitro diagnostic kits and reagents including sample pretreatment, calibrators and quality controls for use in clinical applications with mass spectrometry.
    用于临床质谱检测用的体外诊断试剂盒和试剂(包括前处理液、校准品和质控品)的设计、开发和制造。

    Original Registration Date Effective Date Last Revision Date Expiry Date
    2019-07-05 2025-07-05 2025-03-15 2028-07-04