The CE mark allows using Cytek Northern Lights flow cytometer for clinical diagnostic applications in hospitals, laboratories and clinics across Europe
US-based Cytek Biosciences has secured CE mark approval for its Northern Lights (NL)-CLC flow cytometer for clinical applications in Europe.
The approval enables using Cytek Northern Lights flow cytometer for clinical diagnostic applications in hospitals, laboratories and clinics across Europe.
It also helps the company to advance its efforts to offer a complete spectral flow cytometry solution to the European market ranging from instruments to reagents.
According to the company, Cytek Northern Lights has been designed, manufactured and tested in line with its design controls, quality systems and applicable verification and validation procedures and protocols that are contemplative of flow cytometry in vitro diagnostic medical devices.
The broad testing carried out on these devices has demonstrated that they hold the capacity to perform as per the intended use and specification requirements, said the company.
Cytek’s Northern Lights series is available in multiple configurations
Cytek’s Northern Lights series, which provides high sensitivity and reagent flexibility, is upgradeable and available in configurations from one laser (nine colors) to three lasers (24+ colours).
Available in multiple configurations, Cytek Northern Lights has the capacity to run panels of higher complexity.
Cytek Biosciences CEO Dr Wenbin Jiang said: “Achieving CE Marking and gaining European market access is more proof of our commitment to redefining what is possible in flow cytometry and offering a total solution for clinical applications.
“It speaks volumes about the rigorous attention to detail and quality that we place on our manufacturing processes – and instills a high level of confidence in the researchers and scientists who use our solutions.”
Based in Fremont of California, Cytek Biosciences is a major flow cytometry solution provider that focuses on the development of compact and affordable instruments with high multiplexing capability.
In March 2019, Becton, Dickinson and Company (BD) secured CE-IVD certification for its BD FACSDuet automated flow cytometry system.