康为世纪:子公司获三类医疗器械注册证,有效期至2031年8月16日

智通财经
Aug 18
【康为世纪:子公司获三类医疗器械注册证,有效期至2031年8月16日】康为世纪公告,公司全资子公司江苏健为诊断科技有限公司自主研发的肺炎支原体核酸及耐药突变位点检测试剂盒获得国家药品监督管理局颁发的Ⅲ类《医疗器械注册证》,注册证编号为国械注准20263401716,批准及生效日期为2026年8月17日,有效期至2031年8月16日。该产品用于体外定性检测人咽拭子样本中肺炎支原体DNA及其耐药突变位点,是公司取得的第5张呼吸道疾病检测Ⅲ类注册证。

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