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

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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
FS20010013	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	2001-08-10	郑州绿科生物工程有限公司		Approval Completed-Pending Certificated	2001-12-27	view
FS20020001	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	2002-01-31	吉比有生物技术（北京）有限公司	Beijing BGI-GBI Biotech Co Ltd	Approval Completed-Pending Certificated	2002-07-19	view
CSb20020155	乙型肝炎病毒表面抗原诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Supplementary Application	2002-10-29	英科新创(厦门)科技有限公司	InTec Products INC	Certificate Issued	2004-01-19	view
CSB20020154	速显乙型肝炎病毒表面抗原诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Supplementary Application	2003-01-02	英科新创(厦门)科技有限公司	InTec Products INC	Pending Approval	2004-09-09	view
CSB20020153	速显乙型肝炎病毒表面抗原诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Supplementary Application	2003-01-02	英科新创(厦门)科技有限公司	InTec Products INC	Certificate Issued	2004-10-15	view
X0302347	乙型肝炎病毒表面抗原诊断试剂盒(酶联免疫法)	Diagnostic reagent	IVD	Supplementary Application	2003-05-04	上海实业科华生物技术有限公司	Shanghai Siic Kehua Biotech Co Ltd	Certificate Issued	2003-09-19	view
X0302489	乙型肝炎病毒表面抗原诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Supplementary Application	2003-05-28	上海荣盛生物技术有限公司	Shanghai Rongsheng Biological Pharmaceutical Co Ltd	Certificate Issued	2003-11-07	view
X0303287	乙型肝炎病毒表面抗原诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Supplementary Application	2003-08-29	华美生物工程公司	SINO-AMERICAN BIOTECHNOLOGY Co Ltd	Certificate Issued	2004-03-01	view
X0303288	乙型肝炎病毒表面抗原诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Supplementary Application	2003-08-29	华美生物工程公司	SINO-AMERICAN BIOTECHNOLOGY Co Ltd	Certificate Issued	2004-03-01	view
J0401946	乙型肝炎病毒表面抗原诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	License Renew	2004-10-22	索林诊断（集团）有限公司	DiaSorin SpA	Certificate Issued	2005-04-11	view
Y0415170	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	2004-11-26	北京金伟凯医学生物技术有限公司	Goldenweikai MEDICAL BIOTECHNOLOGY Co Ltd	Certificate Issued	2005-06-24	view
Y0402577	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	2004-11-29	北京金豪制药有限公司	Beijing Kinghawk Pharmaceutical Co Ltd	Certificate Issued	2005-02-25	view
Y0403706	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	2004-11-29	北京金豪制药有限公司	Beijing Kinghawk Pharmaceutical Co Ltd	Certificate Issued	2005-02-25	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
CYSS0500071	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	2005-06-19	北京现代高达生物技术有限责任公司	Beijing Modern Gaoda Biotechnology Co Ltd	Certificate Issued	2006-05-29	view
JYSB0500071	乙型肝炎病毒表面抗原诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Supplementary Application	2005-08-25	生物梅里埃公司	Biomerieux Bv	Certificate Completed-Pending Issued	2006-06-08	view
JYSB0500092	乙型肝炎病毒表面抗原诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Supplementary Application	2005-11-09	生物梅里埃公司	Biomerieux Bv	Certificate Completed-Pending Issued	2006-05-31	view
CYSS0600007	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	2006-03-01	威海威高生物科技有限公司	Weihai Weigao BIOTECHNOLOGY Co Ltd	Certificate Issued	2007-10-10	view
CYSS0600011	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	2006-03-06	北京贝尔生物工程有限公司	Beijing Beier Bioengineering Co Ltd	Certificate Issued	2006-09-06	view
JYSB0600077	乙型肝炎病毒表面抗原诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Supplementary Application	2006-08-02	生物梅里埃公司	Biomerieux Bv	Certificate Issued	2007-08-13	view