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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
Y0415854 糖类抗原19-9免疫放射分析药盒 Diagnostic reagent IVD Generic Drug 2004-12-15 北京北免东雅生物技术研究所 Beijing Beimiandongya Biotechnology Research Institute Certificate Issued 2006-06-28 view
Y0415858 人促甲状腺激素免疫放射分析药盒 Diagnostic reagent IVD Generic Drug 2004-12-15 北京北免东雅生物技术研究所 Beijing Beimiandongya Biotechnology Research Institute Certificate Issued 2006-06-28 view
Y0415853 糖类抗原50免疫放射分析药盒 Diagnostic reagent IVD Generic Drug 2004-12-15 北京北免东雅生物技术研究所 Beijing Beimiandongya Biotechnology Research Institute Certificate Issued 2006-06-28 view
Y0415857 游离三碘甲腺原氨酸放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2004-12-15 北京北免东雅生物技术研究所 Beijing Beimiandongya Biotechnology Research Institute Certificate Issued 2006-06-28 view
Y0415856 糖类抗原125免疫放射分析药盒 Diagnostic reagent IVD Generic Drug 2004-12-15 北京北免东雅生物技术研究所 Beijing Beimiandongya Biotechnology Research Institute Certificate Issued 2006-06-28 view
Y0415855 糖类抗原15-3 免疫放射分析药盒 Diagnostic reagent IVD Generic Drug 2004-12-15 北京北免东雅生物技术研究所 Beijing Beimiandongya Biotechnology Research Institute Certificate Issued 2006-06-28 view
Y0415859 游离甲状腺素放射免疫分析药盒 Diagnostic reagent IVD Generic Drug 2004-12-15 北京北免东雅生物技术研究所 Beijing Beimiandongya Biotechnology Research Institute Certificate Issued 2006-06-28 view
X0306259 促卵泡激素(FSH)化学发光免疫分析试剂盒 Diagnostic reagent IVD New Drug Application 2004-10-15 北京北免东雅生物技术研究所 Beijing Beimiandongya Biotechnology Research Institute Certificate Issued 2005-04-04 view
X0306261 前列腺特异抗原(PSA)化学发光免疫分析试剂盒 Diagnostic reagent IVD New Drug Application 2004-10-15 北京北免东雅生物技术研究所 Beijing Beimiandongya Biotechnology Research Institute Certificate Issued 2005-04-11 view
X0306260 甲状腺素(T4)化学发光免疫分析试剂盒 Diagnostic reagent IVD New Drug Application 2004-10-15 北京北免东雅生物技术研究所 Beijing Beimiandongya Biotechnology Research Institute Certificate Issued 2005-04-13 view
X0303628 促甲状腺激素(TSH)化学发光免疫分析试剂盒 Diagnostic reagent IVD New Drug Application 2004-04-23 北京北免东雅生物技术研究所 Beijing Beimiandongya Biotechnology Research Institute Certificate Issued 2004-12-15 view
X0303456 癌胚抗原(CEA)化学发光免疫分析试剂盒 Diagnostic reagent IVD New Drug Application 2004-04-23 北京北免东雅生物技术研究所 Beijing Beimiandongya Biotechnology Research Institute Certificate Issued 2004-12-17 view
X0303454 CA125 化学发光免疫分析试剂盒 Diagnostic reagent IVD New Drug Application 2004-04-23 北京北免东雅生物技术研究所 Beijing Beimiandongya Biotechnology Research Institute Certificate Issued 2005-02-21 view
X0400668 梅毒螺旋体抗体化学发光免疫分析试剂盒 Diagnostic reagent IVD New Drug Application 2004-02-16 北京北免东雅生物技术研究所 Beijing Beimiandongya Biotechnology Research Institute Certificate Issued 2005-04-19 view
X0302925 SARS冠状病毒抗体(IgG)化学发光免疫分析试剂盒 Diagnostic reagent IVD New Drug Application 2003-06-17 北京北免东雅生物技术研究所 Beijing Beimiandongya Biotechnology Research Institute Certificate Issued 2008-08-07 view