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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSB0600100 前列腺特异抗原(PSA)定量测定试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2007-05-11 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Approval Completed-Pending Certificated view
CXSB0600101 促卵泡激素(FSH)定量测定试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2007-05-11 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd In Approval 2008-07-29 view
CXSB0600102 甲状腺素(T4)定量测定试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2007-05-11 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2008-08-19 view
CXSB0700082 人类免疫缺陷病毒抗体诊断试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2007-11-06 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd In Review 2007-12-24 view
CXSB0700083 梅毒螺旋体抗体诊断试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2008-02-18 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Issued 2008-09-01 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
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
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
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
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
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
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
CXSS0600080 肿瘤相关抗原15-3(CA15-3)定量测定试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2006-09-18 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Completed-Pending Issued view
CXSS0600081 肿瘤相关抗原19-9(CA19-9)定量测定试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2006-09-18 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd In Approval 2007-12-17 view
CXSS0600082 肿瘤相关抗原50(CA50)定量测定试剂盒(化学发光法) Diagnostic reagent IVD New Drug Application 2006-09-18 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Completed-Pending Issued view
CYSB0700124 乙型肝炎病毒表面抗原诊断试剂盒(化学发光法) Diagnostic reagent IVD Supplementary Application 2008-03-25 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd In Approval 2010-08-11 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
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
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
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