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

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Major Special 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
CYSS0500054	甲胎蛋白诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Generic Drug	2005-07-25	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2006-04-10	view
CYSR1200001	丙型肝炎病毒抗体诊断试剂盒(酶联免疫法)	Diagnostic reagent	IVD	State Standards	2012-01-31	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2013-01-30	view
CXSS0600004	层粘连蛋白放射免疫分析药盒	Diagnostic reagent	IVD	New Drug Application	2006-02-22	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2008-03-07	view
CXSS0600117	Ⅳ型胶原放射免疫分析药盒	Diagnostic reagent	IVD	New Drug Application	2006-11-01	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2009-01-19	view
CYSS0600100	碘[125I]糖类抗原19-9免疫放射分析药盒	Diagnostic reagent	IVD	Generic Drug	2007-01-10	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2008-08-07	view
CXSS0500145	前列腺特异抗原化学发光免疫诊断试剂盒	Diagnostic reagent	IVD	New Drug Application	2005-12-29	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2007-04-20	view
CYSS0600003	糖类抗原50免疫放射分析药盒	Diagnostic reagent	IVD	Generic Drug	2006-02-22	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2008-03-07	view
CYSS0600104	碘[125I]雌二醇放射免疫分析药盒	Diagnostic reagent	IVD	Generic Drug	2007-01-10	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2008-08-07	view
CYSS0500135	内皮素放射免疫分析药盒	Diagnostic reagent	IVD	Generic Drug	2006-02-22	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2008-03-07	view
CXSS0600090	乙型肝炎病毒表面抗体时间分辨荧光免疫分析定量试剂盒	Diagnostic reagent	IVD	New Drug Application	2006-10-10	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	In Approval	2008-08-05	view
CYSS0600102	碘[125I]糖类抗原242免疫放射分析药盒	Diagnostic reagent	IVD	Generic Drug	2007-01-10	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2009-01-19	view
CXSS0500144	甲胎蛋白化学发光免疫诊断试剂盒	Diagnostic reagent	IVD	New Drug Application	2005-12-23	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2007-04-20	view
CYSS0600002	前列腺特异抗原免疫放射分析药盒	Diagnostic reagent	IVD	Generic Drug	2006-02-22	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2008-03-07	view
CYSS0600103	碘[125I]甲状腺过氧化酶自身抗体分析药盒	Diagnostic reagent	IVD	Generic Drug	2007-01-10	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2009-01-16	view
CYFB1000044	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	2010-12-03	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2011-03-25	view
CYSS0600006	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	2006-03-02	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Completed-Pending Issued		view
CYSS0600106	碘[125I]神经原特异性烯醇化酶免疫放射分析药盒	Diagnostic reagent	IVD	Generic Drug	2007-01-10	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2009-01-19	view
CXSS0500146	癌胚抗原化学发光免疫诊断试剂盒	Diagnostic reagent	IVD	New Drug Application	2005-12-23	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2007-04-20	view
CYSS0600001	透明质酸放射免疫分析药盒	Diagnostic reagent	IVD	Generic Drug	2006-02-22	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2008-03-07	view
CYSS0600101	碘[125I]糖类抗原153免疫放射分析药盒	Diagnostic reagent	IVD	Generic Drug	2007-01-10	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2009-01-19	view