Cytek Biosciences’ San Diego reagent manufacturing facility has been awarded EN ISO 13485:2016 Quality Management System (QMS) certification. This certification encompasses the design, development, manufacturing, and distribution of reagents and accessories.

Cytek Biosciences的圣地亚哥试剂制造厂已获得EN ISO 13485:2016质量管理体系（QMS）认证。该认证包括试剂和配件的设计，开发，制造和分销。

The ISO 13485 certification achievement is a crucial step towards Cytek’s entry into the U.S. clinical market.

ISO 13485认证成果是Cytek进入美国临床市场的关键一步。

Cytek’s comprehensive suite of reagents is tailored for flow cytometry applications. Cytek recently moved its reagent manufacturing from its Fremont headquarters to San Diego to harmonize processes and respond swiftly to market demands and technology advancements.

Cytek的全套试剂是为流式细胞仪应用量身定制的。Cytek最近将其试剂制造业从弗里蒙特总部迁至圣地亚哥，以协调流程并迅速响应市场需求和技术进步。

The San Diego facility manufactures Cytek’s cFluor, Guava, Muse, and Tonbo reagents.

圣地亚哥工厂生产Cytek的cFluor、Guava、Muse和Tonbo试剂。

'Receiving ISO 13485 certification is a major step in our journey toward making clinical grade reagents readily available and sets the foundation for our continued market expansion,' said Chris Williams, chief operating officer for Cytek Biosciences. 'This certification is a testament to the hard work and dedication of our team, who have worked tirelessly to meet stringent quality standards.

Cytek Biosciences首席运营官克里斯·威廉姆斯（ChrisWilliams）说：“获得ISO 13485认证是我们向临床级试剂供应迈出的重要一步，并为我们继续扩大市场奠定了基础。”这一认证证明了我们团队的辛勤工作和奉献精神，他们为达到严格的质量标准而不懈努力。

It reassures our customers of our commitment to providing high-quality products. We anticipate that our planned expansion into the clinical market in the U.S. will enhance our service offerings and contribute to our revenue growth.”.

它让我们的客户放心，我们致力于提供高质量的产品。我们预计，我们计划在美国临床市场的扩张将增强我们的服务产品，并有助于我们的收入增长。”。

The EN ISO 13485:2016 certification was awarded following a thorough assessment and audit of the facility's QMS by TÜV Rheinland, a leading independent certification body.

EN ISO 13485:2016认证是在领先的独立认证机构TÜV Rheinland对设施的QMS进行全面评估和审核后授予的。

ISO 13485 is a globally recognized standard that outlines the requirements for a comprehensive QMS specific to the medical device industry. The standard covers all aspects of a product's lifecycle, from initial design and development through production and distribution, to promote product safety and reliability..

ISO 13485是全球公认的标准，概述了针对医疗器械行业的全面质量管理体系的要求。该标准涵盖了产品生命周期的各个方面，从最初的设计和开发到生产和分销，以提高产品的安全性和可靠性。。

This certification also facilitates access to international markets by aligning with various regulatory requirements.

该认证还通过与各种监管要求保持一致，有助于进入国际市场。

Cytek’s manufacturing facilities in Wuxi, China, and its headquarters in Fremont, California are also EN ISO 13485:2016 certified.

Cytek在中国无锡的制造工厂及其在加利福尼亚州弗里蒙特的总部也通过了EN ISO 13485:2016认证。