Chinese FDA clears Cytek Biosciences flow cytometry system for clinical use

April 9, 2019
The 13-color flow cytometry system is approved for clinical diagnostic use in hospitals, laboratories, and clinics across China.

Flow cytometry instrumentation maker Cytek Biosciences (Fremont, CA) has received Chinese FDA (CFDA) approval of its DxP Athena 13-color flow cytometer for clinical diagnostic use in hospitals, laboratories, and clinics across China.

Achieving CFDA clearance in China opens the door for the company's entire range of flow cytometry solutions to be approved for clinical use in countries worldwide, notes Wenbin Jiang, CEO of Cytek Biosciences.

The DxP Athena incorporates the company's DxP technology, which gives scientists the ability to resolve dim populations in a multicolor format. The system differs from the company’s flagship Aurora and Northern Lights spectral flow cytometers by its use of traditional flow technology—though assays require only microvolumes of cells and reagents, and generate minimal waste.

Additionally, the company's QbSure QC software has been approved by the CFDA for use with the DxP Athena system.

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

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