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乙型肝炎病毒核酸测定试剂盒(DNA捕获探针法)
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仁度生物:乙肝病毒核酸测定试剂盒获注册证
news flash· 2025-05-30 07:36
Core Viewpoint - The company has received regulatory approval for its hepatitis B virus nucleic acid testing kit, which is expected to enhance its product line and market presence in the infectious disease testing sector [1] Group 1: Product Approval - The hepatitis B virus nucleic acid testing kit (DNA capture probe method) has been granted a Class III registration certificate with a registration number of 202.53 billion [1] - The registration certificate is valid from May 29, 2025, to May 28, 2030 [1] Group 2: Product Features and Market Impact - This new product is part of a series for blood-borne infectious diseases, allowing for the monitoring of HBV DNA baseline levels and changes in patients, which aids in evaluating antiviral treatment responses and effectiveness [1] - The product complements the existing HBV RNA testing, creating a comprehensive "dual-dimension" testing approach and covering the full automated high-sensitivity testing product line for hepatitis B, C, and E [1] - The actual sales performance of this product will depend on future marketing efforts, and its impact on the company's future performance remains uncertain [1]