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

Got biophotonics-related news to share with us? Contact Lee Dubay, Associate Editor, BioOptics World

Get even more news like this delivered right to your inbox

Sponsored Recommendations

Achromatic Lenses: High-Quality Custom Optics

March 13, 2025
Ensure clarity and accuracy in your optics systems with Lacroix’s achromatic lenses. Explore how our custom solutions minimize chromatic aberration for perfect results.

Manufacturing Considerations for Tolerancing Aspheres

March 13, 2025
Understand the critical factors in manufacturing aspheres and how Lacroix Optics ensures precise tolerancing in every optical component.

Explore Our Videos: Insights into Precision Optics

March 13, 2025
Get an inside look at Lacroix Optics with our collection of informative videos showcasing our capabilities, innovations, and processes.

Optical Assemblies: Reliable and Precise Solutions

March 13, 2025
Ensure your optical system works seamlessly with Lacroix Optics' custom optical assemblies. Discover the precision and reliability we bring to every project.

Voice your opinion!

To join the conversation, and become an exclusive member of Laser Focus World, create an account today!