Nanjing Vazyme Biotech (688105.SH) subsidiary obtains two medical device registration certificates.

Nanjing Vazyme Biotech (688105.SH) announced that its wholly-owned subsidiary, Nanjing Vazyme Biotech Medical Technology Co., Ltd., recently received two "Medical Device Registration Certificates" issued by the National Medical Products Administration. The names of the certificates are: Adenovirus Antigen Detection Kit (Colloidal Gold Method) and Adenovirus Antigen Detection Kit (Quantum Dot Fluorescence Immunoassay). The approval of the above-mentioned Adenovirus Antigen Detection Kit registration certificates is an effective complement to the company's existing rapid detection solutions for respiratory pathogens. It can meet the needs of different application scenarios and clinical uses, helping to enhance the company's market competitiveness in related fields. On the Quantum Dot platform, combined with the already-certified Influenza A/B antigen, Respiratory Syncytial Virus antigen, Mycoplasma pneumoniae antibody detection kits, and the company's fully automated fluorescence immunoassay analyzer, it can achieve fully automated, highly sensitive, quantitative detection of 5 major respiratory pathogens, truly achieving sample in, result out, meeting the demand for batch automated testing in tertiary hospitals. By improving detection efficiency and visualizing the disease course through quantitative testing, it can better meet the clinical needs of precision treatment and medication. In addition, the company's Colloidal Gold platform respiratory pathogen detection series already covers Influenza A/B antigen, Respiratory Syncytial Virus antigen, Adenovirus antigen, and Mycoplasma pneumoniae antibody detection kits, meeting the demand for rapid testing in various scenarios such as primary healthcare institutions, customs, and airports.