Chinese FDA clears Cytek’s DxP Athena for clinical diagnostic use

Thirteen-color flow cytometry just became much easier for clinical flow cytometry laboratories based in China. Cytek Biosciences Inc., a leading provider of flow cytometry instrumentation, today announced that the Chinese FDA has cleared its DxP Athena flow cytometer for clinical diagnostic use in hospitals, laboratories and clinics across China.

The China Food and Drug Administration (CFDA) has cleared Cytek Biosciences’ DxP Athena flow cytometer for clinical diagnostic use in hospitals, laboratories and clinics across China. Credit: Cytek Biosciences

Achieving CFDA clearance in China is a testament to the attention to detail and quality that we place on our manufacturing processes, and opens the door for our entire range of flow cytometry solutions to be approved for clinical use in countries worldwide.”

Dr. Wenbin Jiang, CEO of Cytek Biosciences

Manufactured at Cytek’s facility in Wuxi, China, the DxP Athena incorporates Cytek's proven DxP technology, which gives scientists the ability to resolve dim populations in a multicolor format. The Athena is set apart from Cytek’s flagship Aurora and Northern Lights spectral flow cytometers by its use of traditional flow technology. However, like all other Cytek flow cytometer systems, the DxP Athena system is compact, hands-on, affordable, and easy-to-use. Assays require only micro-volumes of cells and reagents, and generate minimal waste.

Additionally, Cytek’s QbSure® QC product has been approved by the CFDA for use with the DxP Athena. Included with the DxP Athena are Cytek’s validation beads and QbSure QC software, which ensure optimal daily instrument performance.

As the next step in its mission to make massively multiparametric flow cytometry accessible to a larger number of researchers, Cytek anticipates CFDA approval for its spectral flow cytometry solutions in 2019.

Source: https://cytekbio.com/pages/compact-flow-cytometry-systems-from-cytek-biosciences-approved-for-clinical-use-in-china

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