Drug Registration and Acceptance

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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
CYSB1800086	人类免疫缺陷病毒抗原抗体诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Supplementary Application	2018-05-10	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2018-07-06	view
CXFB1700001	人类免疫缺陷病毒抗原抗体诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Supplementary Application	2017-10-16	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2018-02-08	view
CYSS1000001	人类免疫缺陷病毒抗原抗体诊断试剂盒(酶联免疫法)	Diagnostic reagent	IVD	Generic Drug	2011-01-17	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2012-11-06	view
CXSS1000028	ABO血型定型试剂盒(固相法)	Diagnostic reagent	IVD	New Drug Application	2011-01-06	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2012-10-30	view
CYSB1000035	人类免疫缺陷病毒抗体诊断试剂盒(双抗原夹心酶联免疫法)	Diagnostic reagent	IVD	Supplementary Application	2010-03-12	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2010-11-12	view
CYSB1000038	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	2010-03-12	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2010-07-21	view
CYSB1000036	丙型肝炎病毒抗体诊断试剂盒(酶联免疫法)	Diagnostic reagent	IVD	Supplementary Application	2010-03-12	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2010-07-05	view
CYSB1000037	梅毒螺旋体抗体诊断试剂盒(双抗原夹心酶联免疫法)	Diagnostic reagent	IVD	Supplementary Application	2010-03-12	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2010-07-05	view
CYSB0600105	人类免疫缺陷病毒抗体诊断试剂盒（胶体金法）	Diagnostic reagent	IVD	Supplementary Application	2007-03-02	英科新创（厦门）科技有限公司	InTec Products INC	In Approval	2010-01-27	view
CYSB0600127	乙型肝炎病毒表面抗原全血诊断试剂盒（胶体金法）	Diagnostic reagent	IVD	Supplementary Application	2007-01-22	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2008-10-29	view
CYSS0600091	吗啡检测试剂（胶体金法）	Diagnostic reagent	IVD	Generic Drug	2006-12-14	英科新创（厦门）科技有限公司	InTec Products INC	In Approval	2008-07-29	view
CYSB0600130	乙肝五项检测卡（胶体金法）	Diagnostic reagent	IVD	Supplementary Application	2007-01-22	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2008-07-21	view
CXSS0500079	人类免疫缺陷病毒HIV -1型抗体尿液检测试剂（胶体金法）	Diagnostic reagent	IVD	New Drug Application	2005-08-03	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2007-08-02	view
CXSS0500073	乙型肝炎病毒表面抗体诊断试剂（胶体金法）	Diagnostic reagent	IVD	New Drug Application	2005-08-03	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2006-12-05	view
CXSS0500075	乙型肝炎病毒e抗体诊断试剂（胶体金法）	Diagnostic reagent	IVD	New Drug Application	2005-08-03	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2006-12-05	view
CXSS0500074	乙型肝炎病毒e抗原诊断试剂（胶体金法）	Diagnostic reagent	IVD	New Drug Application	2005-08-03	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2006-12-05	view
CXSS0500076	乙型肝炎病毒核心抗体诊断试剂（胶体金法）	Diagnostic reagent	IVD	New Drug Application	2005-08-03	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2006-07-14	view
X0401426	乙肝病毒DNA均相荧光PCR定量检测试剂盒	Diagnostic reagent	IVD	New Drug Application	2004-12-23	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2005-12-29	view
Y0403898	乙型肝炎病毒e抗体诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	Generic Drug	2005-01-04	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2005-12-27	view
X0407431	乙型肝炎病毒核心抗原IgM抗体诊断试剂盒（酶联免疫法）	Diagnostic reagent	IVD	New Drug Application	2004-12-09	英科新创（厦门）科技有限公司	InTec Products INC	Certificate Issued	2005-09-20	view