Drug Registration and Acceptance

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Active Ingredient

Acceptance No.

Manufacturers

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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
CYFB1700009	抗A抗B血型定型试剂（单克隆抗体）	Diagnostic reagent	IVD	Supplementary Application	2018-08-02	北京金豪制药股份有限公司	Beijing Kinghawk Pharmaceutical Co Ltd	Certificate Issued	2019-04-22	view
CYSS1100001	人类免疫缺陷病毒抗原抗体诊断试剂盒(酶联免疫法)	Diagnostic reagent	IVD	Generic Drug	2011-09-29	北京金豪制药股份有限公司	Beijing Kinghawk Pharmaceutical Co Ltd	Certificate Issued	2012-05-10	view
CYFB1000076	抗A抗B血型定型试剂(单克隆抗体)	Diagnostic reagent	IVD	Supplementary Application	2011-02-12	北京金豪制药股份有限公司	Beijing Kinghawk Pharmaceutical Co Ltd	Certificate Issued	2011-06-10	view
CYFB1000078	梅毒甲苯胺红不加热血清试验诊断试剂	Diagnostic reagent	IVD	Supplementary Application	2011-02-12	北京金豪制药股份有限公司	Beijing Kinghawk Pharmaceutical Co Ltd	Certificate Issued	2011-06-10	view
CYSB1000053	丙型肝炎病毒抗体诊断试剂盒(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
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
CYSB1000055	人类免疫缺陷病毒(HIV)1+2型抗体诊断试剂盒(酶联免疫双抗原夹心法)	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
CYSB1000054	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	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