Shanghai Kehua Bio-Engineering (SHE:002022) said its unit, Xi'an Tianlong Technology, received a medical device registration certificate from China's National Medical Products Administration, according to a Thursday filing with the Shenzhen Stock Exchange.
The newly approved product, the Human CYP2D6 Genetic Polymorphism Detection Kit (Fluorescent PCR Method), is valid from Dec. 17, 2024, till Dec. 16, 2029. The kit detects specific genetic mutations in human DNA, the filing said.