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System components, including Reagents, Tubing Sets, Instruments, and PBS/EDTA Buffer, are designed, manufactured and tested under a quality system certified to ISO 13485.

In the EU, the CliniMACS System components are available as CE-marked medical devices for their respective intended use, unless otherwise stated. The CliniMACS Reagents and Biotin Conjugates are intended for

in vitro

use only and are not designated for therapeutic use or direct infusion into patients. The CliniMACS Reagents in combination with the CliniMACS System are intended to separate human cells. Miltenyi Biotec as the manufacturer of the CliniMACS System does not give any recommendations regarding the use of separated cells for therapeutic purposes and does not make any claims regarding a clinical benefit. For the manufacturing and use of target cells in humans the national legislation and regulations - e.g., for the EU the Directive 2004/23/EC ("human tissues and cells"), or the Directive 2002/98/EC ("human blood and blood components") - must be followed. Thus, any clinical application of the target cells is exclusively within the responsibility of the user of a CliniMACS System.

In the US, the CliniMACS CD34 Reagent System, including the CliniMACS Plus Instrument, CliniMACS CD34 Reagent, CliniMACS Tubing Sets TS and LS, and the CliniMACS PBS/EDTA Buffer, is FDA approved as a Humanitarian Use Device (HUD), authorized by U.S. Federal law for use in the treatment of patients with acute myeloid leukemia (AML) in first complete remission. The effectiveness of the device for this indication has not been demonstrated. Other products of the CliniMACS Product Line are available for use only under an approved Investigational New Drug (IND) application, Investigational Device Exemption (IDE) or FDA approval.

CliniMACS GMP MicroBeads are for research use and

ex vivo

cell processing only.

CliniMACS MicroBeads are for research use only and not for human therapeutic or diagnostic use.

从1990年，美天旎发明MACS磁珠细胞分离技术开始，我们已经发展成为一个充满朝气的多元化的公司，公司现有1200多名员工，涉及不同领域，如生物医学、物理学、机械工程和技术服务团队。我们研发和生产了一系列的优秀产品，从独特的细胞标记试剂、复杂的细胞分离和分析设备到创新性的临床应用研究系统。美天旎的激情美天旎一向致力于推进生物医学和细胞治疗的研究进展。我们的激情就在于研发出影响基础科研和临床应用的技术和产品。美天旎的客户也非常重视我们的信誉和多年的经验。美天旎的产品 MACS为您提供了从基础科研到临床应用的完整产品线及完美解决方案，涉及样品制备、细胞分离和分析、分子分析、细胞培养和清血疗法相关的产品和服务。从科研工具到GMP级的试剂，美天旎提供了跨领域的应用产品，比如细胞治疗产品就是我们跨学科专家团队共同研究的成果。美天旎的承诺我们的口号是"Researchers working for researchers"，这是我们一直以来能够满足客户需求的源动力。通过整合研究、开发和制造过程，我们对提供高产品质量有自己独特的理解和认识。客户可以完全相信我们的专业知识和我们的技术支持及服务。

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