FREMONT, Calif., Sept. 27, 2023 (GLOBE NEWSWIRE) -- Cytek Biosciences, Inc. (Nasdaq: CTKB), a leading cell analysis solutions company, today announced that it has received EN ISO 13485:2016 Quality Management System (QMS) certification. The certification applies to Cytek’s headquarters and manufacturing operations in Fremont, California for the design, development, manufacturing, distribution, installation and service of flow cytometers, reagents and accessories.

加利福尼亚州弗里蒙特市，2023年9月27日（GLOBE NEWSWIRE）-领先的细胞分析解决方案公司Cytek Biosciences，Inc。（纳斯达克股票代码：CTKB）今天宣布已收到EN ISO 13485:2016质量管理体系（QMS）认证。该认证适用于加利福尼亚州弗里蒙特的Cytek总部和制造业务，用于流式细胞仪，试剂和附件的设计，开发，制造，分销，安装和服务。

The company’s manufacturing facilities in Wuxi, China are also EN ISO 13485:2016 certified..

该公司在中国无锡的制造工厂也获得了EN ISO 13485:2016认证。。

ISO 13485 is the global standard established by the international standards organization to ensure that medical devices meet the proper regulatory compliance laws to keep professionals and customers in clinics, hospitals and other medical settings safe.

ISO 13485是国际标准组织制定的全球标准，旨在确保医疗器械符合适当的法规遵从法律，以确保诊所，医院和其他医疗机构的专业人员和客户安全。

“At Cytek, we have long held a ‘quality first’ mindset – we are constantly striving for higher quality in all that we do, from conception through manufacturing,” said Chris Williams, chief operating officer for Cytek Biosciences. “Having an ISO 13485 certified QMS is a terrific achievement, and bolsters our plans to focus on the translational and clinical markets.

Cytek生物科学首席运营官克里斯·威廉姆斯（Chris Williams）说：“在Cytek，我们长期以来一直保持着“质量优先”的心态-我们一直在努力提高质量，从概念到制造。“拥有ISO 13485认证的质量管理体系是一项了不起的成就，并支持我们专注于转化和临床市场的计划。

This certification sends a strong signal to customers in these segments that we are committed to serving them, and we plan to take every step necessary to responsibly do so in the future.”.

该认证向这些细分市场的客户发出强烈信号，表明我们致力于为他们服务，我们计划在未来采取必要的每一步来负责任地这样做“。

Recognized as a pioneer in spectral flow cytometry, Cytek’s patented Full Spectrum Profiling™ (FSP™) technology empowers scientists, allowing them to go even further with their research – all with greater ease and shorter time to results compared to conventional flow cytometry.

Cytek公司被公认为光谱流式细胞仪的先驱，获得专利的全光谱分析™ （FSP™) 技术赋予科学家权力，允许他们进一步开展他们的研究-与传统的流式细胞仪相比，所有这些都更轻松，更短的时间获得结果。

Cytek’s EN ISO 13485:2016 certification follows extensive analysis and audit of its QMS by TÜV Rheinland®, an independent certification body. Cytek plans to pursue certifications for increasingly stringent standards and regulations, targeting additional geographies to seek authorization to sell its cell analysis solutions for clinical use in countries worldwide.

Cytek的EN ISO 13485:2016认证遵循独立认证机构TÜvRheinland®对其质量管理体系的广泛分析和审核。Cytek计划寻求越来越严格的标准和法规的认证，针对其他地区寻求授权销售其细胞分析解决方案以供全球各国临床使用。

Currently, Cytek solutions are approved for clinical and diagnostic use in China and the European Union, with EN ISO 13485:2016 certification representing a first step to achieve Cytek’s goal of entering the U.S. clinical market..

目前，Cytek解决方案已获中国和欧盟批准用于临床和诊断用途，EN ISO 13485:2016认证是实现Cytek进入美国临床市场目标的第一步。。

Please visit www.cytekbio.com for more information.

请访问www.cytekbio.com了解更多信息。

About Cytek Biosciences, Inc.

关于Cytek生物科学公司。

Cytek Biosciences (Nasdaq: CTKB) is a leading cell analysis solutions company advancing the next generation of cell analysis tools by delivering high-resolution, high-content and high-sensitivity cell analysis utilizing its patented Full Spectrum Profiling™ (FSP™) technology. Cytek’s novel approach harnesses the power of information within the entire spectrum of a fluorescent signal to achieve a higher level of multiplexing with precision and sensitivity.

Cytek Biosciences（纳斯达克股票代码：CTKB）是一家领先的细胞分析解决方案公司，通过利用其专利的全谱分析技术提供高分辨率，高含量和高灵敏度的细胞分析，推动下一代细胞分析工具的发展™ （FSP™) 技术。Cytek的新方法利用荧光信号整个频谱内的信息功率，以精确和灵敏的方式实现更高水平的多路复用。

Cytek’s FSP platform includes its core instruments, the Cytek Aurora™ and Northern Lights™ systems; its cell sorter, the Cytek Aurora™ CS; the flow cytometer and imaging products under the Amnis® and Guava® brands; and reagents, software and services to provide a comprehensive and integrated suite of solutions for its customers.

Cytek的FSP平台包括其核心仪器Cytek Aurora™ 和北灯™ 系统；它的细胞分类器，Cytek Aurora™ 反恐精英；Amnis®和Guava®品牌的流式细胞仪和成像产品；以及试剂，软件和服务，为客户提供全面和集成的解决方案套件。

Cytek is headquartered in Fremont, California with offices and distribution channels across the globe. More information about the company and its products is available at www.cytekbio.com..

Cytek总部设在加利福尼亚州弗里蒙特，拥有遍布全球的办公室和分销渠道。有关公司及其产品的更多信息，请访问www.cytekbio.com。。

Cytek’s products are for research use only and not for use in diagnostic procedures (other than Cytek’s Northern Lights-CLC system and certain reagents, which are available for clinical use in China and the European Union).

Cytek的产品仅供研究使用，不适用于诊断程序（Cytek的Northern Lights CLC系统和某些试剂，可在中国和欧盟临床使用）。

Cytek, Full Spectrum Profiling, FSP, Cytek Aurora, Northern Lights, Amnis and Guava are trademarks of Cytek Biosciences, Inc.

Cytek，Full Spectrum Profiling，FSP，Cytek Aurora，Northern Lights，Amnis和Guava是Cytek Biosciences，Inc。的商标。

In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Cytek uses its website (www.cytekbio.com), LinkedIn page and X (formerly Twitter) account as channels of distribution of information about its company, products, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters.

除了向证券交易委员会（SEC），新闻稿，公开电话和网络广播提交申请外，Cytek还使用其网站（www.cytekbio.com），LinkedIn page和X（以前称为Twitter）帐户作为分发有关其公司，产品，计划财务和其他公告的信息渠道，出席即将举行的投资者和行业会议及其他事项。

Such information may be deemed material information and Cytek may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Cytek’s website, LinkedIn page, and X account in addition to following its SEC filings, news releases, public conference calls and webcasts..

此类信息可能被视为材料信息，Cytek可能会使用这些渠道来遵守FD法规下的披露义务。因此，除了遵循其SEC文件，新闻稿，公共电话会议和网络广播之外，投资者还应监控Cytek的网站，LinkedIn页面和X帐户。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections.

本新闻稿包含1933年“证券法”第27A条（经修订）和1934年“证券交易法”第21E条（经修订）所载1995年“私人证券诉讼改革法”含义内的前瞻性声明。，受这些部分创建的“安全港”的约束。

All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements generally can be identified by the use of forward-looking terminology such as “may,” “might,' 'will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negatives of these terms or variations of them or similar terminology, but the absence of these words does not mean that a statement is not forward-looking.

除历史事实陈述外，所有陈述都可能是前瞻性陈述。前瞻性陈述通常可以通过使用前瞻性术语来识别，例如“可能”，“可能”，“将会”，“应该”，“期望”，“计划”，“预期”，“可能”，“意图”，“目标”，“项目”，“沉思”，“相信”，“估计”，“预测”，“潜力”或“继续”或这些术语或变体的否定它们或类似的术语，但缺少这些词并不意味着陈述不是前瞻性的。

These forward-looking statements include statements regarding Cytek’s business and product plans in the translational and clinical markets; Cytek’s goals and plans to take all necessary steps to achieve higher quality standards; Cytek plans to pursue certifications for increasingly stringent standards and regulations, targeting additional geographies to seek authorization to sell its cell analysis solutions for clinical use in countries worldwide; and Cytek’s goal of entering the U.S.

这些前瞻性声明包括有关Cytek在转化和临床市场的业务和产品计划的声明；Cytek的目标和计划采取一切必要步骤实现更高质量的标准；Cytek计划寻求越来越严格的标准和法规的认证，针对其他地区寻求授权销售其细胞分析解决方案以供全球各国临床使用；和Cytek进入美国的目标。

clinical market. These statements are based on management’s current expectations, forecasts, beliefs, assumptions and information currently available to management. These statements also deal with future events and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the information expressed or implied by these forward-lookin.

临床市场。这些陈述基于管理层目前可供管理层使用的当前期望，预测，信念，假设和信息。这些陈述还涉及未来事件，涉及可能导致实际结果，绩效或成就与这些前瞻性信息所表达或暗示的信息大不相同的已知和未知风险，不确定性和其他因素。

Media Contact:

媒体联系：

Stephanie Olsen

斯蒂芬妮·奥尔森

Lages & Associates

Lages＆Associates

(949) 453-8080

(949) 453-8080

stephanie@lages.com

stephanie@lages.com

Investor Contact:

投资者联系：

Paul Goodson

保罗·古德森

Head of Investor Relations

投资者关系负责人

Cytek Biosciences

Cytek生物科学

pgoodson@cytekbio.com

pgoodson@cytekbio.com