FREMONT, California., Sept. 16, 2020 (GLOBE NEWSWIRE). 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.
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