Drug Registration and Acceptance

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Active Ingredient

Acceptance No.

Manufacturers

Acceptance Date

Status Date

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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
CYSS1400001	乙型肝炎病毒/丙型肝炎病毒/人类免疫缺陷病毒1型核酸检测试剂盒(PCR-荧光探针法)	Diagnostic reagent	IVD	Generic Drug	2015-05-09	北京万泰生物药业股份有限公司	Beijing Wantai Biological Pharmacy Enterprise Co Ltd	Certificate Issued	2017-05-22	view
CYSB2000105	乙型肝炎病毒、丙型肝炎病毒、人类免疫缺陷病毒（1型）核酸检测试剂盒（PCR-荧光法）	Diagnostic reagent	IVD	Supplementary Application	2020-05-23	上海科华生物工程股份有限公司	Shanghai Kehua Bio-Engineering Co Ltd	Certificate Issued	2021-02-26	view
CYSB1800279	乙型肝炎病毒、丙型肝炎病毒、人类免疫缺陷病毒（1型）核酸检测试剂盒（PCR-荧光法）	Diagnostic reagent	IVD	Supplementary Application	2018-12-25	上海科华生物工程股份有限公司	Shanghai Kehua Bio-Engineering Co Ltd	Certificate Issued	2019-09-11	view
CYSB1500190	乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒1型核酸检测试剂盒(PCR-荧光法)	Diagnostic reagent	IVD	Supplementary Application	2015-10-13	北京万泰生物药业股份有限公司	Beijing Wantai Biological Pharmacy Enterprise Co Ltd	Certificate Issued	2016-05-31	view
CYFB1800004	乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒1型核酸检测试剂盒(PCR-荧光法)	Diagnostic reagent	IVD	Supplementary Application	2018-08-06	北京万泰生物药业股份有限公司	Beijing Wantai Biological Pharmacy Enterprise Co Ltd	Certificate Issued	2018-10-29	view