Cytek® Biosciences’ Headquarters Obtains ISO 13485 Certification


Certification demonstrates a company’s dedication to quality across the board and advances the roadmap for the US translational and clinical markets.

Cytek Biosciences, Inc. (Nasdaq: CTKB), a leading provider of cell analysis technologies, announced today that it has achieved EN ISO 13485:2016 Quality Management System (QMS) accreditation. The accreditation is valid for Cytek’s headquarters and production operations in Fremont, California, which design, develop, manufacture, distribute, install, and service flow cytometers, reagents, and accessories. The company’s production facilities in Wuxi, China, are also certified under EN ISO 13485:2016.

The international standards organization created ISO 13485 as a worldwide standard to guarantee that medical devices adhere to the relevant regulatory compliance requirements and protect staff members and patients in clinics, hospitals, and other medical settings.

“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.”

Cytek, a leader in spectral flow cytometry, provides scientists with the tools they need to advance their research with greater ease and faster turnaround times than traditional flow cytometry due to its unique Full Spectrum ProfilingTM (FSPTM) technology.

TÜV Rheinland®, an independent certification agency, conducted a thorough review and audit of Cytek’s QMS before awarding it the EN ISO 13485:2016 certification. Targeting more regions, Cytek intends to obtain certifications for ever-tougher requirements and laws to obtain permission to market its cell analysis products for therapeutic usage in nations all over the world. The EN ISO 13485:2016 accreditation is a first step toward Cytek’s aim of breaking into the U.S. clinical market. Currently, Cytek solutions are certified for clinical and diagnostic usage in China and the European Union.



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