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

Task Type

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
X0305498	癌胚抗原（CEA）化学发光免疫诊断试剂盒	Diagnostic reagent	IVD	New Drug Application	2005-01-28	华美生物工程公司	SINO-AMERICAN BIOTECHNOLOGY Co Ltd	Certificate Issued	2005-08-25	view
X0305482	甲胎蛋白（AFP）化学发光免疫诊断试剂盒	Diagnostic reagent	IVD	New Drug Application	2004-08-12	华美生物工程公司	SINO-AMERICAN BIOTECHNOLOGY Co Ltd	Certificate Issued	2005-01-21	view
X0303288	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	2003-08-29	华美生物工程公司	SINO-AMERICAN BIOTECHNOLOGY Co Ltd	Certificate Issued	2004-03-01	view
X0303287	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	2003-08-29	华美生物工程公司	SINO-AMERICAN BIOTECHNOLOGY Co Ltd	Certificate Issued	2004-03-01	view
X0302569	非典型肺炎冠状病毒核酸扩增（PCR）荧光检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2004-04-28	华美生物工程公司	SINO-AMERICAN BIOTECHNOLOGY Co Ltd	Certificate Issued	2004-09-24	view
X0301949	丙肝病毒核酸扩增(PCR)荧光定量检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2004-02-02	华美生物工程公司	SINO-AMERICAN BIOTECHNOLOGY Co Ltd	Certificate Issued	2004-08-10	view
X0301943	促甲状腺素（TSH）化学发光免疫诊断试剂盒	Diagnostic reagent	IVD	New Drug Application	2003-12-24	华美生物工程公司	SINO-AMERICAN BIOTECHNOLOGY Co Ltd	Certificate Issued	2004-06-11	view
CSS20020039	甲型肝炎病毒IgM抗体酶免诊断试剂盒	Diagnostic reagent	IVD(2)	New Drug Application	2004-01-12	华美生物工程公司河南省生物工程技术研究中心		Certificate Issued	2004-08-16	view
CSS20020016	乙肝病毒核酸扩增(PCR)荧光定量检测试剂盒	Diagnostic reagent	IVD(2)	New Drug Application	2002-03-26	华美生物工程公司河南省生物工程技术研究中心		Certificate Issued	2004-06-23	view
CSS01001	结核分支杆菌PCR分子灯塔荧光检测试剂盒	Diagnostic reagent	IVD(4)	New Drug Application	2001-04-02	华美生物工程公司	SINO-AMERICAN BIOTECHNOLOGY Co Ltd	Certificate Issued	2001-11-28	view
CSb20020078	结核分支杆菌核酸扩增(PCR)酶免检测试剂盒	Diagnostic reagent	IVD(2)	Supplementary Application	2002-08-23	华美生物工程公司	SINO-AMERICAN BIOTECHNOLOGY Co Ltd	Certificate Issued	2003-05-09	view