多重荧光PCR技术
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圣湘生物四款产品取得医疗器械注册证
Zhi Tong Cai Jing· 2025-10-31 09:57
Core Viewpoint - Shengxiang Bio (688289.SH) has recently received medical device registration certificates from the National Medical Products Administration for four products, enhancing its respiratory pathogen detection capabilities [1] Product Registration - The four products include nucleic acid test kits for respiratory syncytial virus, influenza A virus, influenza B virus, adenovirus, and mycoplasma pneumoniae, all utilizing fluorescent PCR technology [1] - These products are characterized by high sensitivity, high specificity, and ease of operation, allowing for accurate identification in as little as 30 minutes [1] Product Series Expansion - With this certification, the "Xiaolianjian" series has expanded to eight products, further enhancing Shengxiang's "6/3+X respiratory infection nucleic acid rapid detection" system [1] - This system enables unified sampling, amplification, and simultaneous detection of various common respiratory pathogens [1] Application and Flexibility - The product series covers common respiratory viruses, bacteria, fungi, atypical pathogens, and drug resistance genes, making it suitable for outpatient, emergency, and inpatient settings [1] - The products support flexible combinations based on clinical presentation, regional, and seasonal epidemic characteristics, effectively addressing complex situations such as co-circulation of multiple pathogens and mixed infections [1]