新型冠状病毒核酸检测试剂盒(荧光PCR法)
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圣湘生物产品取得医疗器械注册证
Zhi Tong Cai Jing· 2025-09-30 08:15
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]
圣湘生物(688289.SH)产品取得医疗器械注册证
智通财经网· 2025-09-30 08:15
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, indicating a significant advancement in its product offerings [1] Group 1: Product Features - The newly certified nucleic acid test kits utilize multiplex fluorescent PCR technology, offering high sensitivity, high specificity, and ease of operation [1] - The tests can accurately identify three pathogens in as little as 30 minutes, enhancing diagnostic efficiency [1] Group 2: Application and Market Relevance - The product can be integrated with the company's existing rapid detection solutions for respiratory infections, allowing for unified sampling and amplification [1] - This series of products covers common respiratory viruses, bacteria, fungi, atypical pathogens, and drug-resistant genes, making it suitable for outpatient, emergency, and inpatient settings [1] - The tests support flexible combinations based on clinical presentation, regional, and seasonal epidemiological characteristics, effectively addressing complex situations such as co-circulation of multiple pathogens and mixed infections [1]