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
CYSS0600053	乙型肝炎病毒核心抗体(HBcAb)诊断试剂盒(酶联免疫法)	Diagnostic reagent	IVD	Generic Drug	2006-06-02	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Completed-Pending Issued		view
CSS00085	促黄体激素诊断试剂（胶体金法）	Diagnostic reagent	IVD(2)	New Drug Application	2000-10-18	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Approval Completed-Pending Certificated	2002-06-14	view
X0302475	便隐血胶体金法检测试剂	Diagnostic reagent	IVD	New Drug Application	2004-01-15	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2004-07-12	view
X0404453	乙肝病毒表面抗原胶体金法检测试剂	Diagnostic reagent	IVD	Supplementary Application	2004-08-12	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2004-12-15	view
X0402674	乙肝两对半（HBV）检测试剂（乳胶法）	Diagnostic reagent	IVD	New Drug Application	2004-12-09	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2005-05-09	view
X0402853	沙眼衣原体乳胶法检测试剂	Diagnostic reagent	IVD	New Drug Application	2004-12-09	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2005-08-19	view
X0402314	甲基安非他命（MET）胶体金法检测试剂	Other	IVD	New Drug Application	2004-05-08	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2005-08-31	view
CYSS0500038	乙型肝炎病毒核心抗体诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Generic Drug	2005-05-17	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2005-10-21	view
CYSS0500037	乙型肝炎病毒表面抗原诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Generic Drug	2005-05-17	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2005-12-07	view
CYSS0500041	乙型肝炎病毒表面抗体诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Generic Drug	2005-05-17	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2005-12-07	view
CYSS0500039	乙型肝炎病毒e抗体诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Generic Drug	2005-05-17	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2005-12-09	view
CYSS0500040	乙型肝炎病毒e抗原诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Generic Drug	2005-05-17	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2005-12-09	view
CXSS0500007	乙肝表面抗体检测试剂（乳胶法）	Diagnostic reagent	IVD	New Drug Application	2005-02-22	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2006-02-10	view
CXSS0500018	乙型肝炎病毒YMDD变异及DNA定量荧光PCR双检试剂盒	Diagnostic reagent	IVD	New Drug Application	2005-03-02	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2006-04-19	view
CYSS0500083	梅毒螺旋体抗体(Anti-TP)诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Generic Drug	2005-10-13	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2006-05-29	view
CXSS0500091	人类免疫缺陷病毒抗体HIV(1/2/O)诊断试剂盒(酶联免疫法)	Diagnostic reagent	IVD	New Drug Application	2005-08-01	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2006-06-08	view
CYSS0500097	丙型肝炎病毒抗体诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Generic Drug	2005-12-12	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2006-08-29	view
CXSS0500104	人类免疫缺陷病毒（HIV）1/2/O型抗体诊断试剂（乳胶层析法）	Diagnostic reagent	IVD	New Drug Application	2005-10-13	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2006-12-05	view
CXSS0500062	氯胺酮检测试剂盒（胶体金法）	Diagnostic reagent	IVD	New Drug Application	2005-08-17	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2007-01-11	view
CXSB0500105	人类免疫缺陷病毒（HIV）1/2型抗体诊断试剂（乳胶层析法）	Diagnostic reagent	IVD	Supplementary Application	2005-10-11	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2008-04-28	view