肺炎支原体核酸检测试剂盒(荧光PCR法)
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圣湘生物:公司四款产品获得医疗器械注册证
Xin Lang Cai Jing· 2025-10-31 14:49
Core Viewpoint - The company, Shengxiang Biology, announced on October 31 that several of its nucleic acid testing kits for respiratory viruses have received medical device registration certificates from the National Medical Products Administration of China, indicating regulatory approval for these products [1] Product Approval - The approved products include nucleic acid testing kits for respiratory syncytial virus, influenza A and B viruses, adenovirus, and mycoplasma pneumoniae, all utilizing fluorescent PCR methods [1] - The approval of these products is expected to enhance the company's market presence and product offerings in the diagnostic sector [1] Future Performance Uncertainty - The future performance of these products will be influenced by multiple factors, including market expansion efforts, brand influence, and actual market demand [1] - The company has indicated that the sales and profit contributions from these products remain uncertain, making it difficult to predict their specific impact on future performance [1]