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    Biobase Biodustry(Shandong) Co., Ltd.

    Biobase Biodustry(Shandong) Co., Ltd.
    Mingshui Economic Development Zone
    Zhangqiu District, Jinan City(Biobase Industrial Park in a
    intersection of East Jingshi Road and
    Mingbu Road)
    250200
    China
    BSI logo

    Certificate number: MD 767775
    Scope: The design, development, manufacture of IVD kits, calibrators and controls for Clinical Chemistry and Immunochemistry, reagents for hematology analyzer.
    临床化学和免疫化学的体外诊断试剂盒、校准品和质控品,血细胞分析仪配套试剂的设计、开发及生产。

    Standard/Scheme number or name Start Date Expiry Date
    ISO 13485:2016 2022-07-14 2028-07-13

    Certificate number: FM 767776
    Scope: The design, development, manufacture of IVD kits, calibrators and controls for Clinical Chemistry and Immunochemistry, reagents for hematology analyzer.
    临床化学和免疫化学的体外诊断试剂盒、校准品和质控品,血细胞分析仪配套试剂的设计、开发及生产。

    Standard/Scheme number or name Start Date Expiry Date
    ISO 9001:2015 2022-06-21 2028-06-21