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
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
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
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
CXSS0600043	CA15-3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
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
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
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
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
CXSS0600134	β地中海贫血反向点杂交（RDB）基因分型检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2007-02-07	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Approval Completed-Pending Certificated		view
CXSS0500161	α－地中海贫血基因诊断试剂盒（gap-PCR法）	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
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
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
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
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
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
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
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