Drug Registration and Acceptance

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Active Ingredient

Acceptance No.

Manufacturers

Acceptance Date

Status Date

Classification

Review Status

Drug Type

Submission

Evaluation Conclusion

ATC Category

Special Approval Varieties

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Visualized Analysis Export Evaluation Conclusion Evaluation Progress

Acceptance No.	Drug Name	Dosage Form	Classification	Submission	Acceptance Date	Manufacturers	Manufacturers	Review Status	Status Date	View
CSZ20020003	乙型肝炎病毒核酸扩增（PCR）荧光检测试剂盒	Diagnostic reagent	IVD(2)	New Drug Application	2002-05-30	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Certificate Issued	2003-06-11	view
X0405546	甲胎蛋白(AFP)定量诊断试剂盒(时间分辨免疫荧光分析法)	Diagnostic reagent	IVD	New Drug Application	2004-09-30	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Certificate Issued	2005-11-03	view
X0408320	癌胚抗原(CEA)定量检测试剂盒（时间分辨免疫荧光分析法）	Diagnostic reagent	IVD	New Drug Application	2005-01-07	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Certificate Issued	2006-05-30	view
CXSS0500003	人巨细胞病毒（HCMV）核酸扩增（PCR）荧光定量检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2005-02-22	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Certificate Issued	2006-07-25	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
CXSS0500068	人乳头瘤病毒（HPV）6，11型核酸扩增（PCR）荧光定量检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2005-06-30	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Certificate Issued	2007-01-11	view
CXSS0500057	总前列腺特异性抗原(tPSA)定量检测试剂盒（时间分辨免疫荧光分析法）	Diagnostic reagent	IVD	New Drug Application	2005-07-01	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Certificate Issued	2006-06-02	view
CXSB0500078	结核分支杆菌核酸扩增（PCR）荧光检测试剂盒	Diagnostic reagent	IVD	Supplementary Application	2005-09-01	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Certificate Issued	2006-02-08	view
CXFS0500061	肺炎支原体（MP）核酸扩增（PCR）荧光定量检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2005-10-11	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Certificate Completed-Pending Issued		view
CXSS0500121	乙型肝炎病毒表面抗原(HBsAg)定量测定试剂盒（时间分辨免疫荧光法）	Diagnostic reagent	IVD	New Drug Application	2005-10-28	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Certificate Completed-Pending Issued		view
CXSS0500122	乙型肝炎病毒表面抗体(HBsAb)定量测定试剂盒（时间分辨免疫荧光法）	Diagnostic reagent	IVD	New Drug Application	2005-10-28	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Certificate Completed-Pending Issued		view
CXSS0500138	人类免疫缺陷病毒1型（HIV-1）巢式核酸扩增 ( 巢式PCR ) 荧光定量检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2005-12-29	中山大学达安基因股份有限公司	Daan Gene Co Ltd	In Approval	2008-07-08	view
CXSS0600003	乙型肝炎病毒e抗原（HBeAg）定量测定试剂盒（时间分辨免疫荧光法）	Diagnostic reagent	IVD	New Drug Application	2006-01-24	中山大学达安基因股份有限公司	Daan Gene Co Ltd	In Approval	2008-06-13	view
CXSS0600002	乙型肝炎病毒核心抗体（抗-HBc）定量测定试剂盒（时间分辨免疫荧光法）	Diagnostic reagent	IVD	New Drug Application	2006-01-24	中山大学达安基因股份有限公司	Daan Gene Co Ltd	In Approval	2008-06-13	view
CXSS0500164	CA125定量测定试剂盒（时间分辨免疫荧光法）	Diagnostic reagent	IVD	New Drug Application	2006-01-24	中山大学达安基因股份有限公司	Daan Gene Co Ltd	In Approval	2007-07-13	view
CXSS0500165	CA19-9定量测定试剂盒（时间分辨免疫荧光法）	Diagnostic reagent	IVD	New Drug Application	2006-01-24	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Certificate Completed-Pending Issued		view
CXSS0500154	解脲脲原体（UU）核酸扩增（PCR）荧光定量检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2006-01-24	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Certificate Completed-Pending Issued		view
CXSS0600001	乙型肝炎病毒e抗体（抗-HBe）定量测定试剂盒（时间分辨免疫荧光法）	Diagnostic reagent	IVD	New Drug Application	2006-01-24	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Approval Completed-Pending Certificated		view
CXSS0600006	高危型人乳头瘤病毒（HR-HPV）核酸扩增（PCR）荧光定量检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2006-03-02	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Certificate Completed-Pending Issued		view
CXSS0500173	单纯疱疹病毒Ⅱ型（HSVⅡ）核酸扩增（PCR）荧光定量检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2006-03-02	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Certificate Completed-Pending Issued		view