Cytek Biosciences Receives ISO 13485 Certification at San Diego Reagent Facility

Cytek Biosciences’ San Diego reagent manufacturing facility has been awarded EN ISO 13485:2016 Quality Management System (QMS) certification. This certification encompasses the design, development, manufacturing, and distribution of reagents and accessories. 
 
The ISO 13485 certification achievement is a crucial step towards Cytek’s entry into the U.S. clinical market.
 
Cytek’s comprehensive suite of reagents is tailored for flow cytometry applications. Cytek recently moved its reagent manufacturing from its Fremont headquarters to San Diego to harmonize processes and respond swiftly to market demands and technology advancements. 
 
The San Diego facility manufactures Cytek’s cFluor, Guava, Muse^, and Tonbo reagents.
 
“Receiving ISO 13485 certification is a major step in our journey toward making clinical grade reagents readily available and sets the 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.”
 
The EN ISO 13485:2016 certification was awarded following a thorough assessment and audit of the facility’s QMS by TÜV Rheinland, a leading independent certification body.
 
ISO 13485 is a globally recognized standard that outlines the requirements for a comprehensive QMS specific to the medical device industry. The standard covers all aspects of a product’s lifecycle, from initial design and development through production and distribution, to promote product safety and reliability.
 
This certification also facilitates access to international markets by aligning with various regulatory requirements.
 
Cytek’s manufacturing facilities in Wuxi, China, and its headquarters in Fremont, California are also EN ISO 13485:2016 certified.