Action required: Please refresh your browser
We have recently implemented some changes that require a hard refresh of your browser: Please hold down the CTRL-key and press the F5 key.
After a successful hard refresh, this message should not appear anymore.
More details about this topic are available here »
Cytek® Biosciences Receives CE Marking for Series of cFluor® Reagents, TBNK Kit | ||
By: GlobeNewswire - 24 May 2022 | Back to overview list |
|
Company Moves to Make Total Cell Analysis Solutions Available for Clinical Applications in the European Market FREMONT, Calif., May 24, 2022 (GLOBE NEWSWIRE) -- Clinical flow cytometry laboratories based in Europe can now purchase Cytek cFluor® CE-IVD-certified reagents for their use. Cytek Biosciences, Inc. (Nasdaq: CTKB), a leading cell analysis solutions company, today 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. For more information about Cytek’s cFluor reagents and kits, please visit https://cytekbio.com/collections/reagents. About Cytek Biosciences, Inc. Cytek Biosciences (Nasdaq: CTKB) is a leading cell analysis solutions company advancing the next generation of cell analysis tools by delivering high-resolution, high-content and high-sensitivity cell analysis utilizing its patented Full Spectrum Profiling™ (FSP™) technology. Cytek’s novel approach harnesses the power of information within the entire spectrum of a fluorescent signal to achieve a higher level of multiplexing with precision and sensitivity. Cytek’s FSP platform includes its core instruments, the Aurora and Northern Lights™ systems; its cell sorter, the Aurora CS; and reagents, software and services to provide a comprehensive and integrated suite of solutions for its customers. Cytek is headquartered in Fremont, California with offices and distribution channels across the globe. More information about the company and its products is available at www.cytekbio.com. Other than Cytek’s Northern Lights CLC system and certain reagents for use therewith, which are available for clinical use in countries where the regulatory approval has been obtained from the local regulatory authorities, including China and the European Union, Cytek’s products are for research use only and not for use in diagnostic procedures. Please contact your local sales representatives for the status of local regulatory approval. Cytek, cFluor, Full Spectrum Profiling, FSP and Northern Lights are trademarks or registered trademarks of Cytek Biosciences, Inc. In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Cytek uses its website (www.cytekbio.com), LinkedIn page and corporate Twitter account as channels of distribution of information about its company, products, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Cytek may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Cytek’s website, LinkedIn page, and Twitter account in addition to following its SEC filings, news releases, public conference calls and webcasts. Forward-Looking Statements Media Contact: Investor Contact: |
||
|
||
Copyright 2022 GlobeNewswire | Back to overview list |