Drug Registration and Acceptance

Drug Name

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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
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
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
CXSS0600008	解脲脲原体（UU）基因分型反向点杂交（RDB）检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2006-05-16	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Approval Completed-Pending Certificated		view
CXSS0800001	血源筛查HBV、HCV、HIV-1病毒核酸检测试剂盒（PCR-荧光探针法）	Diagnostic reagent	Biological Products	New Drug Application	2008-05-19	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Certificate Issued	2010-12-07	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
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
CXSS0600101	细胞角蛋白19片段定量测定试剂盒（时间分辨免疫荧光法）	Diagnostic reagent	IVD	New Drug Application	2006-11-01	中山大学达安基因股份有限公司	Daan Gene Co Ltd	In Approval	2008-07-29	view
CXSS0600102	神经元特异性烯醇化酶定量测定试剂盒（时间分辨免疫荧光法）	Diagnostic reagent	IVD	New Drug Application	2006-11-01	中山大学达安基因股份有限公司	Daan Gene Co Ltd	In Approval	2008-07-29	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
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
CXSS0600044	游离前列腺特异性抗原定量测定试剂盒（时间分辨免疫荧光法）	Diagnostic reagent	IVD	New Drug Application	2006-04-19	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Approval Completed-Pending Certificated		view
CXSS0500169	淋球菌（NGH）核酸扩增（PCR）荧光定量检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2006-04-02	中山大学达安基因股份有限公司	Daan Gene Co Ltd	In Approval	2008-07-29	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
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
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
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
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
CXSS0500170	人乳头瘤病毒（HPV）反向点杂交（RDB）基因分型检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2006-04-02	中山大学达安基因股份有限公司	Daan Gene Co Ltd	In Approval	2008-07-29	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
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