Sansure Biotech Inc. (688289.SH) has obtained medical device registration certificates for four products.
Shengxiang Biology (688289.SH) issued an announcement that the company's four products recently received approval from the National Medical Products Administration.
Sansure Biotech Inc. (688289.SH) announced that its four products have recently received the Medical Device Registration Certificate issued by the National Medical Products Administration. These products include Respiratory Syncytial Virus Nucleic Acid Detection Kit (Fluorescent PCR), Type A Influenza Virus, Type B Influenza Virus, Adenovirus Nucleic Acid Detection Kit (Fluorescent PCR), Type A Influenza Virus, Type B Influenza Virus, Mycoplasma pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR), and Human Rhinovirus, Adenovirus, Mycoplasma pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR).
The four products certified this time all use multiple fluorescent PCR technology, with advantages such as high sensitivity, high specificity, and easy operation, capable of accurate identification within 30 minutes. With this, the company's "Xiao Lianjian" series products have expanded to 8, further improving the Saint Xiang "6/3+X Respiratory Tract Infection Nucleic Acid Rapid Detection" system, which allows for unified sampling, unified amplification, and synchronous detection of multiple common respiratory pathogens. This series of products covers common respiratory viruses, bacteria, fungi, atypical pathogens, and drug-resistant genes, widely applicable in outpatient, emergency, and inpatient settings, supporting flexibly combined different testing products based on patients' clinical presentations, regional and seasonal characteristics, better addressing the complex situations of co-circulation of multiple pathogens and mixed infections, providing strong support for precise clinical medication and antimicrobial management.
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