Drug Registration and Acceptance

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Active Ingredient

Acceptance No.

Manufacturers

Acceptance Date

Status Date

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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
CSS01039	人类免疫缺陷病毒抗体诊断试剂盒（金标法）	Diagnostic reagent	IVD(2)	New Drug Application	2001-09-26	北京金伟凯医学生物技术有限公司	Goldenweikai MEDICAL BIOTECHNOLOGY Co Ltd	Certificate Issued	2003-05-30	view
Y0415170	乙型肝炎病毒表面抗原诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Generic Drug	2004-11-26	北京金伟凯医学生物技术有限公司	Goldenweikai MEDICAL BIOTECHNOLOGY Co Ltd	Certificate Issued	2005-06-24	view
CSS01038	丙型肝炎病毒分片段酶联免疫检测试剂盒	Diagnostic reagent	IVD(2)	New Drug Application	2001-09-26	中国人民解放军军事医学科学院基础医学研究所北京金伟凯医学生物技术有限公司		Certificate Issued	2003-02-11	view
X0400664	SARS冠状病毒抗体酶联免疫检测试剂盒（双抗原夹心法）	Diagnostic reagent	IVD	New Drug Application	2004-12-28	北京金伟凯医学生物技术有限公司	Goldenweikai MEDICAL BIOTECHNOLOGY Co Ltd	Certificate Issued	2006-08-29	view