Cytek Biosciences Earns ISO 13485 Certification
Today, Cytek Biosciences, Inc. (Nasdaq: CTKB) announced that its reagent manufacturing facility in San Diego has received the EN ISO 13485:2016 Quality Management System (QMS) certification. This esteemed certification covers the design, development, manufacturing, and distribution of reagents and accessories, underscoring the company's commitment to maintaining high-quality standards. Additionally, Cytek's manufacturing sites in Wuxi, China, and its headquarters are also certified under EN ISO 13485:2016.
What is ISO 13485 Certification?
ISO 13485 is an internationally recognized standard that specifies the requirements for a comprehensive QMS tailored for the medical device sector. It is vital for medical devices to consistently meet quality and regulatory standards, which are essential for ensuring patient safety and effective healthcare delivery. This standard covers every stage of a product's lifecycle, from initial design and development to production and distribution, with the aim of promoting product safety and reliability. Moreover, obtaining ISO 13485 certification helps companies access international markets by aligning with various regulatory requirements.
Innovations in Reagent Manufacturing
Cytek offers a wide range of reagents specifically designed for flow cytometry applications. To streamline operations and quickly adapt to market needs and technological advancements, Cytek has relocated its reagent manufacturing from Fremont to San Diego. The San Diego facility is now responsible for producing Cytek’s cFluor, Guava, Muse, and Tonbo reagents, which enhances both efficiency and product availability.
Insights from Company Leadership
"Achieving ISO 13485 certification marks a significant milestone in our mission to make clinical-grade reagents more accessible, and it lays a strong foundation for our ongoing market expansion," stated Chris Williams, Chief Operating Officer of Cytek Biosciences. "This certification reflects the dedication and hard work of our team, who have consistently met stringent quality standards. It reassures our customers of our commitment to delivering top-notch products. We believe that our planned expansion into the U.S. clinical market will enhance our service offerings and drive revenue growth."
Significance of ISO 13485 Certification
The EN ISO 13485:2016 certification was granted after a comprehensive assessment and audit of the facility's QMS by a respected independent certification body. Currently, Cytek’s products are approved for clinical and diagnostic use in multiple regions, including China and the European Union. Securing ISO 13485 certification is a pivotal achievement for Cytek, paving the way for its entry into the U.S. clinical market.
About Cytek Biosciences, Inc.
Cytek Biosciences (Nasdaq: CTKB) is a prominent company specializing in cell analysis solutions, advancing innovative tools for cell analysis through high-resolution, high-content, and high-sensitivity analysis using its patented Full Spectrum Profiling™ (FSP™) technology. Cytek’s unique approach leverages the full spectrum of fluorescent signals, enabling a higher level of multiplexing with precision and sensitivity. The company’s FSP platform includes key instruments such as the Cytek Aurora and Northern Lights systems, its cell sorter, Cytek Aurora CS, along with a variety of imaging products under the Amnis and Guava brands, complemented by an extensive range of reagents, software, and service solutions.
Global Reach
Cytek is based in Fremont, California, with offices and distribution networks worldwide. For more information about the company and its offerings, please visit their website.
Media and Investor Contacts
Media Contact:
Stephanie Olsen
Lages & Associates
(949) 453-8080
stephanie@lages.com
Investor Contact:
Paul Goodson
Head of Investor Relations
Cytek Biosciences
pgoodson@cytekbio.com
Frequently Asked Questions
What is ISO 13485 certification?
ISO 13485 certification is an internationally recognized standard for quality management systems that focuses specifically on the medical device industry, ensuring product safety and effectiveness.
Why is ISO 13485 certification important for Cytek?
This certification validates Cytek's commitment to maintaining high-quality manufacturing processes, which is essential for entering both international and clinical markets.
What products does Cytek manufacture?
Cytek produces a variety of reagents for flow cytometry applications, including cFluor, Guava, Muse, and Tonbo reagents.
Where is Cytek Biosciences headquartered?
Cytek Biosciences is headquartered in Fremont, California, and also has facilities in Wuxi, China, along with a manufacturing site in San Diego.
How can I contact Cytek Biosciences?
For media inquiries, please reach out to Stephanie Olsen at Lages & Associates. For investor inquiries, contact Paul Goodson, the Head of Investor Relations at Cytek Biosciences.
