China NMPA clears Cytek reagents for clinical flow cytometry use

Dec. 18, 2019
All seven of the company’s flow cytometry reagents have been cleared for clinical diagnostic use in hospitals, laboratories, and clinics across China.

Cytek Biosciences (Fremont, CA), a provider of flow cytometry instrumentation, has received approval from the China National Medical Products Administration (NMPA) for its Class I IVD flow cytometry reagents. All seven of the company’s reagents have been cleared for clinical diagnostic use in hospitals, laboratories, and clinics across China. This achievement follows the company’s Northern Lights spectral flow cytometer having been granted clinical approval by the NMPA, enabling Cytek to offer a complete system application solution to the Chinese flow cytometry market.

Used to stain cells for analysis, reagents are critical to the operation of flow cytometers. The company’s initial family of reagents consists of basic T, B, and NK cell CD markers used for lymphocyte subset detection. 

As one of the most widely used flow cytometry clinical applications, lymphocyte subset detection is a common test that is carried out in many clinical laboratories. The results are proven to have unique clinical significance and value in the diagnosis and treatment of many diseases, such as immunodeficiency diseases, autoimmune diseases, tumors, and viral infections, among others. The basic detecting cluster of differentiation (CD) markers for lymphocyte subsets are CD3, CD4, CD8, CD16+56, CD19, and CD45, all of which are available as reagents from Cytek. 

Having passed all of China’s regulatory requirements, the company will move on to obtain clinical approval in other countries worldwide, according to Wenbin Jiang, CEO of Cytek Biosciences. 

For more information, please visit cytekbio.com.

Source: Cytek Biosciences press release - 12/17/19

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We edited the content of this article, which was contributed by outside sources, to fit our style and substance requirements. (Editor’s Note: BioOptics World has folded as a brand and is now part of Laser Focus World, effective in 2022.)

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