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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS0500065 乙型肝炎病毒表面抗原(HBsAg)测定试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2005-08-09 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2007-01-11 view
CXSS0500067 人类免疫缺陷病毒(HIV)1+2型抗体诊断试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2005-08-09 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2006-08-02 view
CXSS0500066 梅毒螺旋体抗体(Anti -TP)诊断试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2005-08-09 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2007-01-11 view
CYSS0500100 碘[125I] 前列腺特异抗原免疫放射分析药盒 Diagnostic reagent IVD Generic Drug 2005-10-28 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2006-09-15 view
CYSS0500103 碘[125I] 孕酮放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2005-10-28 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2006-09-15 view
CYSS0500099 碘[125I] 人血清睾酮放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2005-10-28 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2006-09-11 view
CYSS0500104 碘[125I] 人尿白蛋白放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2005-10-28 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2006-09-15 view
CXSS0500115 乙型肝炎病毒e抗体测定试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2005-10-28 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Completed-Pending Issued view
CYSS0500098 碘[125I] 雌二醇放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2005-10-28 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2006-09-15 view
CYSS0500102 碘[125I] C-肽放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2005-10-28 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2006-09-15 view
CYSS0500106 碘[125I] 铁蛋白放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2005-10-28 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2006-09-15 view
CYSS0500101 碘[125I] 泌乳素放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2005-10-28 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2006-09-15 view
CYSS0500105 碘[125I] 甘胆酸放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2005-10-28 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2006-09-15 view
CXSS0500116 乙型肝炎病毒e抗原测定试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2005-11-10 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Completed-Pending Issued view
CYSS0500114 碘[125I] 血管紧张素Ⅱ放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2005-11-20 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2006-09-15 view
CXSS0500142 碘[125I] 层粘连蛋白放射免疫分析药盒 Diagnostic reagent IVD New Drug Application 2005-11-20 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2008-01-10 view
CXSS0500141 碘[125I]IV型胶原放射免疫分析药盒 Diagnostic reagent IVD New Drug Application 2005-11-20 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2008-01-10 view
CYSS0500117 碘[125I] 透明质酸放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2005-11-20 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2006-09-15 view
CYSS0500116 碘[125I] 血浆醛固酮放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2005-11-20 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2006-09-15 view
CYSS0500115 碘[125I] 血管紧张素Ⅰ放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2005-12-07 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2006-09-15 view