Drug Registration and Acceptance

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Acceptance No.

Manufacturers

Acceptance Date

Status Date

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Evaluation Conclusion

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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
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
CYFB1000031	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	2010-08-16	郑州安图绿科生物工程有限公司	Autobio Diagnostics Co Ltd	Certificate Issued	2010-11-12	view
CYSB0800171	乙型肝炎病毒表面抗原诊断试剂盒(酶联免疫法)	Diagnostic reagent	Biological Products	Supplementary Application	2008-12-12	郑州安图绿科生物工程有限公司	Autobio Diagnostics Co Ltd	Certificate Issued	2009-04-08	view
CYSB1800177	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	2018-08-30	郑州安图生物工程股份有限公司	Autobio Diagnostics Co Ltd	Certificate Issued	2018-10-29	view
CYSB1000038	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	2010-03-12	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2010-07-21	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
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
CYSB1000187	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	2010-09-15	艾康生物技术（杭州）有限公司	Acon Biotech (Hangzhou) Co Ltd	Certificate Issued	2010-12-01	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
JYSZ0900048	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	2009-12-09	索林诊断（集团）有限公司	DiaSorin SpA	Certificate Issued	2010-04-26	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
JYSZ0800034	乙型肝炎病毒表面抗原诊断试剂盒（酶联免疫法）	Diagnostic reagent	Biological Products	License Renew	2008-06-03	生物梅里埃公司	Biomerieux Bv	Certificate Issued	2009-07-20	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
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
CYFB0900040	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	2009-07-24	珠海丽珠试剂股份有限公司	Zhuhai Livzon Diagnostics INC	Certificate Issued	2010-11-23	view
CYSB1500108	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	2015-06-29	珠海丽珠试剂股份有限公司	Zhuhai Livzon Diagnostics INC	Certificate Issued	2016-02-03	view
CYSB1700228	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	2017-12-14	珠海丽珠试剂股份有限公司	Zhuhai Livzon Diagnostics INC	Certificate Issued	2018-05-08	view
CYFB1200068	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	2012-07-06	珠海丽珠试剂股份有限公司	Zhuhai Livzon Diagnostics INC	Certificate Issued	2012-10-30	view