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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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