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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYSS0600067 乙型肝炎病毒表面抗体测定试剂盒(化学发光法) Diagnostic reagent IVD Generic Drug 2006-06-27 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Completed-Pending Issued 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
CYSS0600069 乙型肝炎病毒核心抗体测定试剂盒(化学发光法) Diagnostic reagent IVD Generic Drug 2006-06-27 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Completed-Pending Issued view
CYSS0600074 甲胎蛋白(AFP)定量测定试剂盒(化学发光法) Diagnostic reagent IVD Generic Drug 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
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
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
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
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
CYSS0600068 丙型肝炎病毒抗体诊断试剂盒(化学发光法) Diagnostic reagent IVD Generic Drug 2006-06-27 北京科美东雅生物技术有限公司 Beijing Chemclin Biotech Co Ltd Certificate Completed-Pending Issued 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
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
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
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
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
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
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
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
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