Sansure Biotech has obtained medical device registration certificates for four products
Sansure Biotech recently announced that four of its products have received medical device registration certificates issued by the National Medical Products Administration. These products include nucleic acid detection kits for respiratory syncytial virus, influenza virus, and Mycoplasma pneumoniae using multiplex fluorescent PCR technology, which offer high sensitivity and ease of operation. This certification expands the company's "Xiao Lian Jian" series products to eight, further improving the rapid nucleic acid testing system for respiratory infections, widely applicable to various clinical scenarios
According to the announcement from Sansure Biotech (688289.SH), the company has recently received the "Medical Device Registration Certificate" issued by the National Medical Products Administration for four of its products, including the respiratory syncytial virus nucleic acid detection kit (fluorescent PCR method), influenza A virus, influenza B virus, adenovirus nucleic acid detection kit (fluorescent PCR method), influenza A virus, influenza B virus, Mycoplasma pneumoniae nucleic acid detection kit (fluorescent PCR method), and human rhinovirus, adenovirus, Mycoplasma pneumoniae nucleic acid detection kit (fluorescent PCR method).
All four products certified this time utilize multiplex fluorescent PCR technology, featuring high sensitivity, high specificity, and ease of operation, capable of precise identification in as little as 30 minutes. With this, the company's "Xiaolianjian" series products have expanded to eight models, further enhancing Sansure's "6/3+X rapid detection system for respiratory infections," which allows for unified sampling, unified amplification, and simultaneous detection of various common respiratory pathogens. This series of products covers common respiratory viruses, bacteria, fungi, atypical pathogens, and drug-resistant genes, making it widely applicable in outpatient, emergency, and inpatient settings. It also supports flexible combinations of different testing products based on patient clinical manifestations, regional, and seasonal epidemic characteristics, better addressing complex situations such as co-circulation of multiple pathogens and mixed infections, providing strong support for precise clinical medication and antimicrobial stewardship
