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Cytek Biosciences Receives CE Marking for Flow Cytometry Reagents, TBNK Kit

NEW YORK ─ Cytek Biosciences said on Tuesday it has obtained CE marking under the European Union In Vitro Diagnostic Medical Devices Directive for a series of single-color cFluor reagents and a six-color T-cell, B-cell, and NK-cell (TBNK) kit, enabling their use for clinical diagnostics by flow cytometry laboratories in Europe and other geographies that accept the designation.

Cytek Biosciences CEO Wenbin Jiang said the CE marking allows Cytek to enter new markets for clinical in vitro diagnostics, adding that its cFluor reagents "represent our years of experience understanding full spectrum cytometry and how fluorophores react together in multicolor panels."

The reagents are validated on the Cytek Aurora and Cytek Northern Lights cell analysis systems.

The Fremont, California-based firm said it continues to seek regulatory approvals and target additional geographies with the aim of offering its range of cell analysis products for clinical use worldwide.