Cytek Biosciences Receives CE Marking on Its Northern Lights (NL)-CLC Platform
Company Moves to Make Complete Spectral Flow Cytometry Solution Available for Clinical Applications in the European Market
FREMONT, Calif., September 16, 2020 – Clinical flow cytometry laboratories based in Europe can now go beyond 24 colors – easily and affordably. Cytek Biosciences Inc., a leading provider of cell analysis instrumentation and solutions, today announced that its Cytek® Northern Lights flow cytometer (product certification abbreviation NL-CLC) has received CE Marking under the European Union In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC. This achievement makes Cytek Northern Lights available for clinical diagnostic use in hospitals, laboratories and clinics across Europe, and positions the company on a path to offering a complete spectral flow cytometry solution to the European market – from instruments to reagents.
Cytek Northern Lights has been designed, manufactured and tested in accordance with Cytek design controls, quality systems and applicable verification and validation procedures and protocols that are reflective of flow cytometry in vitro diagnostic medical devices. The extensive testing that has been conducted on these devices has shown that they are capable of performing to their stated intended use and specification requirements.
“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,” noted Dr. Wenbin Jiang, CEO of Cytek Biosciences. “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.”
Cytek Northern Lights offers a value-added package with capabilities that go beyond flow cytometry systems with a much higher price tag. Upgradeable and available in configurations from one laser (nine colors) to three lasers (24+ colors), Cytek’s Northern Lights series offers high sensitivity and reagent flexibility. With multiple configurations available, Cytek Northern Lights sits in a sweet spot for scientists that have budgeted for a one- to three-laser system but desire the ability to run panels of higher complexity. Until now, such panels would only be achievable using a conventional flow cytometer’s most expensive configuration.
Cytek continues to seek regulatory approvals, targeting additional geographies to ensure that its entire range of flow cytometry solutions will be authorized for clinical use in countries worldwide.
Please visit www.cytekbio.com for more information.
About Cytek Biosciences Inc.
Cytek Biosciences Inc. is a leading flow cytometry solution provider that develops compact, affordable instruments with high multiplexing capability and a wide range of services to support scientists and clinicians. Cytek is headquartered in Fremont, California with branch offices and distribution channels across the globe. More information about the company and its products is available at www.cytekbio.com. To learn more, follow Cytek on LinkedIn, Twitter and Facebook.
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