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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0408256 新型冠状病毒核酸扩增(PCR)荧光检测试剂盒 Diagnostic reagent IVD Supplementary Application 2005-01-05 深圳市匹基生物工程股份有限公司 Qiagen (SHENZHEN) Company Limited In Approval 2016-12-29 view
X0404715 新型冠状病毒核酸扩增(PCR)-荧光检测试剂盒 Diagnostic reagent IVD Supplementary Application 2004-08-23 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd In Approval 2006-07-20 view
X0306796 新型冠状病毒核酸扩增(PCR)荧光检测试剂盒 Diagnostic reagent IVD Supplementary Application 2004-07-15 深圳市匹基生物工程股份有限公司 Qiagen (SHENZHEN) Company Limited Approval Completed-Pending Certificated 2004-07-14 view
CXSB0500034 新型冠状病毒核酸扩增(PCR)荧光检测试剂盒 Diagnostic reagent IVD Supplementary Application 2005-04-27 中山大学达安基因股份有限公司 Daan Gene Co Ltd In Approval 2010-01-27 view