Certification Validates Company’s Commitment to Quality in all Areas, Helping to Advance Roadmap for Translational and Clinical Markets in the United States
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. The company’s manufacturing facilities in Wuxi, China are also EN ISO 13485:2016 certified.
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.
“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. 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.”
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’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. 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.
Please visit www.cytekbio.com for more information.
About Cytek Biosciences, Inc.
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’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 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’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, Full Spectrum Profiling, FSP, Cytek Aurora, Northern Lights, Amnis and Guava are trademarks of Cytek Biosciences, Inc.
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. 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.
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. 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. 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. 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-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to Cytek’s ability to manage the growth and complexity of its organization and maintain and further improve its quality management system; Cytek’s ability to manage relationships with key customers and suppliers; Cytek’s ability to retain key employees; Cytek’s ability to continue to stay in compliance with its material contractual obligations, applicable laws and regulations; global economic and market conditions; and Cytek’s dependence on certain sole and single source suppliers. You should refer to the section entitled “Risk Factors” set forth in Cytek’s Quarterly Report on Form 10-Q filed with the SEC on August 8, 2023 and other filings Cytek Biosciences makes with the SEC from time to time for a discussion of important factors that may cause actual results to differ materially from those expressed or implied by Cytek’s forward-looking statements. Although Cytek believes that the expectations reflected in the forward-looking statements are reasonable, it cannot provide any assurance that these expectations will prove to be correct nor can it guarantee that the future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or occur. The forward-looking statements in this press release are based on information available to Cytek as of the date hereof, and Cytek disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Cytek’s views as of any date subsequent to the date of this press release.
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