Drug Registration and Acceptance

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Manufacturers

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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
CXSS0800018	HBV/HCV/HIV-1核酸检测试剂盒（荧光PCR法）	Diagnostic reagent	Biological Products	New Drug Application	2008-06-12	上海浩源生物科技有限公司	Shanghai Haoyuan Biotech Co Ltd	Certificate Issued	2010-09-16	view
CXSS0600023	乙型肝炎/丙型肝炎病毒核酸扩增微流芯片检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2006-03-28	上海浩源生物科技有限公司	Shanghai Haoyuan Biotech Co Ltd	Certificate Issued	2008-06-20	view
CXSS0700065	乙型肝炎、丙型肝炎、人免疫缺陷病毒（HIV-1）核酸扩增微流芯片检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2007-12-25	上海浩源生物科技有限公司	Shanghai Haoyuan Biotech Co Ltd	Certificate Issued	2009-10-21	view
CYSB1500098	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	2015-08-24	上海浩源生物科技有限公司	Shanghai Haoyuan Biotech Co Ltd	Certificate Issued	2016-04-18	view
CYSB1800147	乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒（I型）核酸检测试剂盒（PCR-荧光法）	Diagnostic reagent	IVD	Supplementary Application	2018-07-23	上海浩源生物科技有限公司	Shanghai Haoyuan Biotech Co Ltd	Certificate Issued	2019-02-14	view
CXSS0700012	人免疫缺陷病毒（HIV-1）巢式核酸扩增微流芯片检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2007-03-14	上海浩源生物科技有限公司	Shanghai Haoyuan Biotech Co Ltd	In Approval	2008-11-21	view
CXSS1000008	人类免疫缺陷病毒(HIV-1)、丙型肝炎病毒、乙型肝炎病毒核酸检测试剂盒(PCR-荧光法)	Diagnostic reagent	IVD	New Drug Application	2010-10-11	上海浩源生物科技有限公司	Shanghai Haoyuan Biotech Co Ltd	Certificate Issued	2011-09-29	view