NEW YORK — Cytek Biosciences said on Tuesday that its portfolio of seven Class I IVD flow cytometry reagents has received approval from the China National Medical Products Administration (NMPA).
According to the Fremont, California-based company, the reagents consist of basic T, B, and NK cell cluster of differentiation markers used for lymphocyte subset detection.
"Having passed all of China’s regulatory requirements, we will move on to obtain clinical approval in other countries worldwide," Cytek CEO Wenbin Jiang said in a statement.
In September, Cytek received NMPA approval for its Northern Lights flow cytometer for clinical diagnostic use in hospitals, laboratories, and clinics. The company also recently received NMPA clearance for its DxP Athena 13-color flow cytometer.