Cytek Biosciences Receives ISO 13485 Certification
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Cytek Biosciences Achieves ISO 13485 Certification
Today, Cytek Biosciences, Inc. (Nasdaq: CTKB)announced that its San Diego reagent manufacturing facility has been awarded EN ISO 13485:2016 Quality Management System (QMS) certification. This prestigious certification encompasses the design, development, manufacturing, and distribution of reagents and accessories, highlighting the company's adherence to rigorous quality standards. Cytek’s manufacturing facilities in Wuxi, China, and its headquarters are also EN ISO 13485:2016 certified.
Understanding ISO 13485 Certification
ISO 13485 is a globally recognized standard that outlines the requirements for a comprehensive QMS specific to the medical device industry. It is crucial for medical devices to meet consistent quality and regulatory requirements, which are essential for patient safety and effective healthcare delivery. The standard encompasses all aspects of a product's lifecycle, including initial design, development, production, and distribution, aimed at promoting product safety and reliability. Furthermore, ISO 13485 certification facilitates access to international markets by aligning with various regulatory demands.
Advancements in Reagent Manufacturing
Cytek’s comprehensive suite of reagents is tailored for flow cytometry applications. As part of an effort to harmonize processes and respond swiftly to market demands and technology advancements, Cytek has recently moved its reagent manufacturing from its Fremont headquarters to San Diego. The San Diego facility now manufactures Cytek’s cFluor, Guava, Muse, and Tonbo reagents, enhancing efficiency and product availability.
Statements from Company Leadership
"Receiving ISO 13485 certification is a major step in our journey toward making clinical-grade reagents readily available and establishes a solid 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. 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."
Importance of ISO 13485 Certification
The EN ISO 13485:2016 certification was awarded following a thorough assessment and audit of the facility's QMS by a leading independent certification body. Currently, Cytek’s products are approved for clinical and diagnostic use in several regions including China and the European Union. Achieving ISO 13485 certification is a critical milestone for Cytek, paving the way for entry into the U.S. clinical market.
About Cytek Biosciences, Inc.
Cytek Biosciences (Nasdaq: CTKB) is a leading cell analysis solutions company, advancing cutting-edge cell analysis tools by delivering high-resolution, high-content, and high-sensitivity 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, achieving a higher level of multiplexing with precision and sensitivity. The company’s FSP platform includes core instruments such as the Cytek Aurora and Northern Lights systems, its cell sorter, Cytek Aurora CS, and a variety of imaging products under the Amnis and Guava brands, supplemented by comprehensive reagents, software, and service solutions.
Global Presence
Cytek is headquartered in Fremont, California, with offices and distribution channels across the globe. More information about the company and its products can be located on 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 a globally recognized standard for quality management systems specifically for the medical device industry, ensuring product safety and efficiency.
Why is ISO 13485 certification important for Cytek?
This certification affirms Cytek's commitment to quality in its manufacturing processes, facilitating its entry into international and clinical markets.
What products does Cytek manufacture?
Cytek manufactures a range 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, with additional facilities in Wuxi, China, and a manufacturing site in San Diego.
How can I contact Cytek Biosciences?
For media inquiries, contact Stephanie Olsen at Lages & Associates. For investor inquiries, reach out to Paul Goodson, Head of Investor Relations at Cytek Biosciences.
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