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
CYSB2000339	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	2020-12-14	中山大学达安基因股份有限公司	Daan Gene Co Ltd	In Review	2020-12-11	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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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