Drug Registration and Acceptance

Drug Name

Exact

Active Ingredient

Acceptance No.

Manufacturers

Acceptance Date

Status Date

Classification

Review Status

Drug Type

Submission

Evaluation Conclusion

ATC Category

Special Approval Varieties

Task Type

Major Special Varieties

Sequence No.

Stock Code

Visualized Analysis Export Evaluation Conclusion Evaluation Progress

Acceptance No.	Drug Name	Dosage Form	Classification	Submission	Acceptance Date	Manufacturers	Manufacturers	Review Status	Status Date	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
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
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
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
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
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