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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CSS20020034 人类免疫缺陷病毒抗体诊断试剂盒(金标法) Diagnostic reagent IVD(4) New Drug Application 2002-07-15 广州万孚生物技术有限公司 Guangzhou Wondfo BIOTECH Co Ltd Certificate Issued 2003-03-05 view
CXSS0500006 乙肝两对半测试卡(胶体金法) Diagnostic reagent IVD New Drug Application 2005-02-22 广州万孚生物技术有限公司 Guangzhou Wondfo BIOTECH Co Ltd Certificate Issued 2005-11-03 view
CXSS0500030 乙型肝炎病毒表面抗体(HBsAb)诊断剂试 Diagnostic reagent IVD New Drug Application 2005-03-28 广州万孚生物技术有限公司 Guangzhou Wondfo BIOTECH Co Ltd Certificate Issued 2005-12-19 view
CXSS0500059 乙型肝炎病毒表面抗原(HBsAg)检测试剂(胶乳法) Diagnostic reagent IVD New Drug Application 2005-08-11 广州万孚生物技术有限公司 Guangzhou Wondfo BIOTECH Co Ltd Certificate Issued 2006-06-02 view
CXSS0700003 丙型肝炎病毒抗体(HCV)检测试剂(免疫层析法) Diagnostic reagent IVD New Drug Application 2007-02-07 广州万孚生物技术有限公司 Guangzhou Wondfo BIOTECH Co Ltd Certificate Issued 2008-10-21 view
CYSB0600086 吗啡检测诊断试剂(胶体金法) Diagnostic reagent IVD Supplementary Application 2006-11-23 广州万孚生物技术有限公司 Guangzhou Wondfo BIOTECH Co Ltd Certificate Issued 2008-09-22 view
CYSB0600115 人类免疫缺陷病毒抗体(HIV1/2)诊断试剂盒(胶体金法) Diagnostic reagent IVD Supplementary Application 2007-03-02 广州万孚生物技术有限公司 Guangzhou Wondfo BIOTECH Co Ltd Certificate Issued 2009-10-30 view
CYSB0600118 乙型肝炎病毒表面抗原诊断试剂(胶乳法) Diagnostic reagent IVD Supplementary Application 2007-03-02 广州万孚生物技术有限公司 Guangzhou Wondfo BIOTECH Co Ltd Certificate Issued 2008-04-09 view
X0303489 梅毒抗体-乙肝表面抗原诊断试剂盒(胶体金法) Diagnostic reagent IVD New Drug Application 2004-08-04 广州万孚生物技术有限公司 Guangzhou Wondfo BIOTECH Co Ltd Certificate Issued 2004-12-24 view
X0406761 冰毒快速检测试剂(胶体金法) Diagnostic reagent IVD New Drug Application 2004-11-17 广州万孚生物技术有限公司 Guangzhou Wondfo BIOTECH Co Ltd Certificate Issued 2005-12-31 view
Y0303682 吗啡检测诊断试剂(胶体金法) Diagnostic reagent IVD Generic Drug 2004-05-26 广州万孚生物技术有限公司 Guangzhou Wondfo BIOTECH Co Ltd Certificate Issued 2004-11-08 view
Y0303684 便隐血检测诊断试剂(胶体金法) Diagnostic reagent IVD Generic Drug 2004-05-26 广州万孚生物技术有限公司 Guangzhou Wondfo BIOTECH Co Ltd Certificate Issued 2004-11-16 view
Y0304360 人绒毛膜促性腺激素诊断试剂(胶体金法) Diagnostic reagent IVD Generic Drug 2004-05-26 广州万孚生物技术有限公司 Guangzhou Wondfo BIOTECH Co Ltd Pending Approval 2004-09-23 view
Y0412029 乙肝两对半测试卡(胶体金法) Diagnostic reagent IVD Generic Drug 2004-10-25 广州万孚生物技术有限公司 Guangzhou Wondfo BIOTECH Co Ltd Certificate Issued 2005-04-18 view