China-based Shanghai Kehua Bioengineering Co., Ltd. (KHB) (SHE: 002022) announced on July 23, 2025, that its controlling subsidiary, Suzhou Tianlong Science and Technology Co., Ltd., has received two in vitro diagnostic (IVD) medical device registration certificates from China’s National Medical Products Administration (NMPA). The approved products are the Respiratory Syncytial Virus Nucleic Acid Detection Kit (Fluorescent PCR Method) and the Adenovirus Nucleic Acid Detection Kit (Fluorescent PCR Method). Both certificates are valid until July 16, 2030.
Product Details
Both products are designed for the in vitro qualitative detection of nucleic acids from their respective viruses in human pharyngeal swab samples. These certifications mark a significant milestone in the company’s expansion of its diagnostic capabilities.
Business Impact
The company stated that the approval of these related products will enrich its product line and have a positive impact on its business development. This expansion into new diagnostic areas is expected to enhance Kehua Bio-engineering’s market position and customer offerings.-Fineline Info & Tech
