Clinical flow cytometry laboratories based in Europe can now purchase Cytek cFluor® CE-IVD-certified reagents for their use. Cytek Biosciences, Inc., a cell analysis solutions company, has announced that a series of single-color cFluor reagents and a 6-color TBNK kit have received CE Marking under the European Union In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC. Other regions that accept the CE marking are also included in the certification.
This achievement makes cFluor reagents available for clinical diagnostic use in hospitals, laboratories and clinics across Europe, and positions the company on a path to offering a total cell analysis solution to the European market – from instruments to reagents.
Cytek’s cFluor reagents have 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 reagents has shown that they are capable of performing to their stated intended use and specification requirements.
“CE-IVD certification allows Cytek to enter into new markets for clinical in vitro diagnostics,” noted Dr. Wenbin Jiang, CEO of Cytek Biosciences. “We continue to maintain a deep focus on providing a complete cell analysis solution to our customers – and achieving CE Marking and gaining European market access extends this commitment. Cytek cFluor reagents represent our years of experience understanding full spectrum cytometry and how fluorophores react together in multicolor panels. Using cFluor reagents, scientists and researchers can go even further with our unique, state-of-the-art cell analyzers – and feel confident in doing so.”
Cytek’s cFluor reagents are all validated on the Cytek® Aurora and Cytek® Northern Lights™ cell analysis systems, ensuring optimal performance for users in a multicolor environment. Cytek continues to seek regulatory approvals, targeting additional geographies to ensure that its entire range of cell analysis solutions will be authorized for clinical use in countries worldwide.
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