Drug Registration and Acceptance

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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
JYSZ2300022	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	2023-05-25					view
CYFB1000016	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	2010-10-26	北京华大吉比爱生物技术有限公司	Beijing BGI-GBI Biotech Co Ltd	In Review		view
CYSB1000058	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	2010-10-26	北京科卫临床诊断试剂有限公司	Beijing Kewei Clinical Diagnostic Reagent Inc	In Review		view
JYSB2400240	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	2024-11-13		DiaSorin SpA			view
CYSB1000056	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	2010-10-27	北京金豪制药股份有限公司	Beijing Kinghawk Pharmaceutical Co Ltd	In Review		view
CYSB2300233	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	2023-12-20		Zhuhai Livzon Diagnostics INC			view
JYSZ2300036	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	2023-09-02					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
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
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
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
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
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
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