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

Sequence No.

Stock Code

Visualized Analysis Export Evaluation Conclusion Evaluation Progress

Acceptance No.	Drug Name	Dosage Form	Classification	Submission	Acceptance Date	Manufacturers	Review Status	Status Date	View
CSS00071	梅毒特异性抗体胶体金检测试剂盒	Diagnostic reagent	IVD(3)	New Drug Application	2000-09-29	郑州绿科生物工程有限公司	Certificate Issued	2002-03-11	view
CSS20020046	人类免疫缺陷病毒抗体诊断试剂盒（胶体金法）	Diagnostic reagent	IVD(3)	New Drug Application	2002-08-16	郑州绿科生物工程有限公司	Certificate Issued	2003-09-05	view
FS20010013	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	2001-08-10	郑州绿科生物工程有限公司	Approval Completed-Pending Certificated	2001-12-27	view
FS20010014	乙型肝炎病毒核心抗体诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Generic Drug	2001-08-10	郑州绿科生物工程有限公司	Approval Completed-Pending Certificated	2001-12-27	view
FS20010015	乙型肝炎病毒表面抗体诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Generic Drug	2001-08-10	郑州绿科生物工程有限公司	Approval Completed-Pending Certificated	2001-12-27	view
FS20010016	梅毒甲苯胺红不加热血清实验诊断试剂	Diagnostic reagent	IVD	Generic Drug	2001-08-10	郑州绿科生物工程有限公司	Approval Completed-Pending Certificated	2002-02-20	view
FS20010017	乙型肝炎病毒e抗原诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Generic Drug	2001-08-10	郑州绿科生物工程有限公司	Approval Completed-Pending Certificated	2001-12-27	view
FS20010018	乙型肝炎病毒e抗体诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Generic Drug	2001-08-10	郑州绿科生物工程有限公司	Approval Completed-Pending Certificated	2001-12-27	view
FS20010019	丙型肝炎病毒抗体诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Generic Drug	2001-08-10	郑州绿科生物工程有限公司	Approval Completed-Pending Certificated	2001-12-27	view
X0305710	甲胎蛋白化学发光定量检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2004-09-09	郑州绿科生物工程有限公司	Certificate Issued	2005-11-07	view
X0306846	催乳素化学发光检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2004-09-09	郑州绿科生物工程有限公司	Certificate Issued	2005-03-03	view
X0306861	癌抗原125化学发光定量检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2004-09-09	郑州绿科生物工程有限公司	Certificate Issued	2005-03-04	view
X0306865	促甲状腺激素化学发光定量检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2004-09-09	郑州绿科生物工程有限公司	Certificate Issued	2005-02-21	view
X0401087	甲状腺素化学发光定量检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2004-11-30	郑州绿科生物工程有限公司	Certificate Issued	2005-06-08	view
X0401789	乙型肝炎病毒表面抗原化学发光免疫诊断试剂盒	Diagnostic reagent	IVD	New Drug Application	2004-04-19	郑州绿科生物工程有限公司	Certificate Issued	2006-12-05	view
Y0401448	甲胎蛋白诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Generic Drug	2004-08-19	郑州绿科生物工程有限公司	Certificate Issued	2004-12-20	view
Y0401449	癌胚抗原诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Generic Drug	2004-08-19	郑州绿科生物工程有限公司	Certificate Issued	2004-12-20	view