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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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
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
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
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
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
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
CYSS0900006	梅毒螺旋体抗体诊断试剂盒(酶联免疫双抗原夹心法)	Diagnostic reagent	IVD	Generic Drug	2010-09-17	北京北方生物技术研究所	Beijing North Institute of BIOTECHNOLOGY Co Ltd	Certificate Issued	2013-02-06	view
CXSS0500172	Ⅲ型前胶原氨端肽（PⅢNP）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	2008-11-28	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