Sansure Biotech products obtain medical device registration certificate
Sansure Biotech recently obtained the medical device registration certificate issued by the National Medical Products Administration. The products include nucleic acid detection kits for human coronaviruses, parainfluenza viruses, and novel coronaviruses. This kit uses multiplex fluorescent PCR technology, featuring high sensitivity and high specificity, capable of detecting three pathogens in as fast as 30 minutes. It is suitable for various clinical scenarios and supports flexible combination testing to address complex infection situations
According to the Zhitong Finance APP, Sansure Biotech (688289.SH) announced that its products for the detection of human coronavirus, parainfluenza virus, and novel coronavirus nucleic acid testing kits (fluorescent PCR method) have recently received the "Medical Device Registration Certificate" issued by the National Medical Products Administration.
The certified human coronavirus, parainfluenza virus, and novel coronavirus nucleic acid testing kits utilize multiplex fluorescent PCR technology, offering advantages such as high sensitivity, high specificity, and ease of operation, capable of accurately identifying three pathogens in as little as 30 minutes. This product can be combined with the company's existing rapid nucleic acid testing solutions for respiratory infections, allowing for unified sampling and amplification, enabling 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 patients' clinical presentations, regional characteristics, and seasonal prevalence, better addressing complex situations such as co-circulation of multiple pathogens and mixed infections, providing strong support for clinical precision medication and antimicrobial stewardship
