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肺炎支原体核酸检测试剂盒(荧光PCR法)
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硕世生物:取得肺炎支原体核酸检测试剂盒医疗器械注册证
news flash· 2025-06-27 07:40
Core Viewpoint - The company has received a medical device registration certificate from the National Medical Products Administration for its Mycoplasma pneumoniae nucleic acid detection kit (fluorescent PCR method), enhancing its product range and competitiveness in the in vitro diagnostics field [1] Group 1 - The product is classified as a Class III medical device with registration number 20253401261 and is valid until June 26, 2030 [1] - The kit is designed for the qualitative detection of Mycoplasma pneumoniae nucleic acid in throat swabs and sputum samples [1] - The acquisition of this registration certificate is expected to improve the company's market expansion capabilities [1] Group 2 - The actual sales performance of the product will depend on market promotion effectiveness and demand [1] - The company is currently unable to predict the impact of this product on its financial performance [1]