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迈克生物股份有限公司是中国具规模的临床体外诊断产品研发、生产企业之一。始创于1994年的迈克生物股份有限公司一直以来专注于体外诊断产品的研究、生产、销售和服务。
公司是经国家相关部门认证的“高新技术企业”，先后通过了CMD ISO13485、CQC ISO14001、TUV ISO13485 认证和部分产品CE认证。公司拥有研发、生产和管理运营团队；已完成从生物原材料、医学实验室产品到专业化服务的全产业链发展布局；具备研发制造体外诊断设备、试剂、校准品和质控品的系统化专业能力；产品涵盖生化、免疫、检测、血液、分子诊断、病理等技术平台。
公司是国际临床化学与检验医学联合会（IFCC）企业会员，是获得CNAS医学参考实验室认可的企业，是进入国际溯源联合委员会（JCTLM）医学参考测量实验室列表的企业，是欧盟标准物质委员会（IRMM）合作成员，承担国际参考物质赋值工作。
公司与国内、外的研究开发机构紧密结合，通过引进研发、生产及检测设备，逐渐形成了有特色的创新体系；与社会相关优势单位、实验室及个人合作，构建面向21世纪检验医学的创新型开放实验室。公司拥有丰富的市场管理经验和渠道管理能力，为产品经销商及终端客户提供完善的专业化服务。
公司以“科技服务人类健康”为使命，坚持量值溯源能力及医学实验室建设能力的提升，把为客户提供优质的产品作为企业的尊严和责任，将人类生命健康事业作为企业不断前进的动力和方向。
英文翻译：Mike biology Co., Ltd. is one of the large-scale clinical in vitro diagnostic product R & D and production enterprises in China. Founded in 1994, Mike biology Co., Ltd. has been focusing on the research, production, sales and service of in vitro diagnostic products. The company is a "high-tech enterprise" certified by relevant national departments, and has successively passed the certification of cmdiso13485, cqcsiiso14001, tuviso13485 and CE certification of some products. The company has a R & D, production and management operation team; has completed the whole industrial chain development layout from biological raw materials, medical laboratory products to professional services; has a systematic professional ability to develop and manufacture in vitro diagnostic equipment, reagents, calibrators and quality control products; products cover biochemical, immune, detection, blood, molecular diagnosis, pathology and other technical platforms. The company is an enterprise member of the International Federation of clinical chemistry and laboratory medicine (IFCC), an enterprise recognized by CNAs medical reference laboratory, an enterprise entering the list of medical reference measurement laboratories of JCTLM, and a cooperative member of IRMM, undertaking the assignment of international reference materials. The company is closely connected with research and development institutions at home and abroad. Through the introduction of R & D, production and testing equipment, the company has gradually formed a distinctive innovation system. It cooperates with relevant social advantageous units, laboratories and individuals to build an innovative and open laboratory for laboratory medicine in the 21st century. The company has rich experience in market management and channel management capabilities, and provides perfect professional services for product distributors and end customers. The company takes "science and technology serve human health" as its mission, adheres to the improvement of the capacity of traceability and medical laboratory construction, takes providing customers with high-quality products as the dignity and responsibility of the enterprise, and takes human life and health as the driving force and direction of the enterprise's continuous progress.
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