Drug Registration and Acceptance

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Acceptance No.

Manufacturers

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Status Date

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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
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
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
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
CXFB1700002	乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒（1型）核酸检测试剂盒（PCR-荧光法）	Diagnostic reagent	IVD	Supplementary Application	2017-11-28	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Certificate Issued	2018-02-23	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
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
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
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
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
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
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
CYFB1600009	乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒(1型)核酸检测试剂盒(PCR-荧光法)	Diagnostic reagent	IVD	Supplementary Application	2016-02-29	中山大学达安基因股份有限公司	Daan Gene Co Ltd	Certificate Issued	2016-08-01	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
CXSS0500166	EB病毒（EBV）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	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
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
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
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
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
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