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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0302380 SARS病毒核酸扩增(HPV)荧光检测试剂盒 Diagnostic reagent IVD New Drug Application 2003-08-25 深圳市匹基生物工程股份有限公司 Qiagen (SHENZHEN) Company Limited Certificate Issued 2003-10-23 view
X0304974 SARS病毒核酸扩增(PCR)荧光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2004-07-22 深圳市匹基生物工程股份有限公司 Qiagen (SHENZHEN) Company Limited Certificate Issued 2009-02-25 view
X0306829 丙型肝炎病毒(HCV)核酸扩增(PCR)荧光定量检测试剂盒 Diagnostic reagent IVD Supplementary Application 2004-07-19 深圳市匹基生物工程股份有限公司 Qiagen (SHENZHEN) Company Limited Certificate Issued 2004-11-22 view
X0306231 乙型肝炎病毒(HBV)核酸扩增(PCR)荧光定量检测试剂盒 Diagnostic reagent IVD Supplementary Application 2003-12-10 深圳市匹基生物工程股份有限公司 Qiagen (SHENZHEN) Company Limited Certificate Issued 2004-06-23 view
X0301228 人乳头瘤病毒(HPV)核酸扩增(PCR)荧光检测试剂盒 Diagnostic reagent IVD New Drug Application 2003-12-17 深圳市匹基生物工程股份有限公司 Qiagen (SHENZHEN) Company Limited Certificate Issued 2004-06-18 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
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
X0302093 结核分枝杆菌(TB)核酸扩增(PCR)荧光检测试剂盒 Diagnostic reagent IVD Supplementary Application 2003-04-22 深圳市匹基生物工程股份有限公司 Qiagen (SHENZHEN) Company Limited Certificate Issued 2003-11-18 view