智通财经APP讯，迈克生物(300463.SZ)公告，公司4项化学发光试剂产品于近日获得欧盟公告机构BSI签发的IVDR CE证书。巨细胞病毒IgG抗体测定试剂盒(直接化学发光法)与巨细胞病毒IgM抗体检测试剂盒(直接化学发光法)均主要用于巨细胞病毒感染的辅助诊断;风疹病毒IgM抗体检测试剂盒(直接化学发光法)与风疹病毒IgG抗体测定试剂盒(直接化学发光法)均主要用于风疹病毒感染的辅助诊断。根据欧盟体外诊断医疗器械法规的规定，上述取得IVDR CE证书的产品已经具备进入欧盟市场的必要条件，有助于提升公司海外市场综合竞争力，对海外市场的拓展以及公司未来的经营将产生积极影响。
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