Product News: Reagents from Cytek Biosciences granted approval for clinical use in China

From instruments to reagents, China-based clinical flow cytometry laboratories are now able to purchase reagents for spectral flow cytometry. 

Cytek Biosciences Inc. has received approval from the China National Medical Products Administration (NMPA) for its Class I IVD flow cytometry reagents. All 7 of Cytek’s reagents have been cleared for clinical diagnostic use in hospitals, laboratories and clinics across China. This achievement follows the Cytek 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. Cytek’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, viral infections, and 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.

“Being granted NMPA clearance is no simple task, and is a testament to our continued commitment to pushing the field of flow cytometry forward,” noted Dr. Wenbin Jiang, CEO of Cytek Biosciences. “Having passed all of China’s regulatory requirements, we will move on to obtain clinical approval in other countries worldwide. We will not rest until we make the benefits of massively multiparametric flow cytometry accessible to a larger number of researchers.”

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