圣湘生物产品取得医疗器械注册证

Core Viewpoint - Shengxiang Bio (688289.SH) has received a medical device registration certificate from the National Medical Products Administration for its nucleic acid test kits for human coronavirus, parainfluenza virus, and novel coronavirus, utilizing multiplex fluorescent PCR technology [1] Group 1: Product Features - The nucleic acid test kits demonstrate high sensitivity, high specificity, and ease of operation, capable of accurately identifying three pathogens in as little as 30 minutes [1] - The product can be integrated with the company's existing rapid detection solutions for respiratory infections, allowing for unified sampling and amplification to detect multiple common respiratory pathogens simultaneously [1] Group 2: Application and Market Scope - This series of products covers common respiratory viruses, bacteria, fungi, atypical pathogens, and drug resistance genes, making it suitable for outpatient, emergency, and inpatient settings [1] - The kits support flexible combinations of different testing products based on patient clinical presentations, regional characteristics, and seasonal prevalence, effectively addressing complex situations of co-circulation and mixed infections, thereby providing strong support for precise medication and antibiotic management in clinical settings [1]