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科华生物(002022.SZ)获国家药监局批准:新增幽门螺杆菌抗体检测试剂盒

Shanghai Kehua Bio-engineering (002022.SZ) has been approved by the National Medical Products Administration: new test kit for Helicobacter pylori antibody detection.

Gelonghui Finance ·  Jan 1 17:46

On January 1, Gelonghui reported that Shanghai Kehua Bio-engineering (002022.SZ) announced that it recently received the medical instruments registration certificate issued by the National Medical Products Administration (in vitro diagnostic reagents). The specific product is "Helicobacter pylori antibody detection kit (latex immunoturbidimetry method)", with registration certificate number National Medical Device Approval 20243402655, valid from December 30, 2024, to December 29, 2029. This product is used for the qualitative detection of Helicobacter pylori antibodies in human serum and plasma samples.

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