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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0400664 SARS冠状病毒抗体酶联免疫检测试剂盒(双抗原夹心法) Diagnostic reagent IVD New Drug Application 2004-12-28 北京金伟凯医学生物技术有限公司 Goldenweikai MEDICAL BIOTECHNOLOGY Co Ltd Certificate Issued 2006-08-29 view
Y0415170 乙型肝炎病毒表面抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2004-11-26 北京金伟凯医学生物技术有限公司 Goldenweikai MEDICAL BIOTECHNOLOGY Co Ltd Certificate Issued 2005-06-24 view
CSS01039 人类免疫缺陷病毒抗体诊断试剂盒(金标法) Diagnostic reagent IVD(2) New Drug Application 2001-09-26 北京金伟凯医学生物技术有限公司 Goldenweikai MEDICAL BIOTECHNOLOGY Co Ltd Certificate Issued 2003-05-30 view
CSS01038 丙型肝炎病毒分片段酶联免疫检测试剂盒 Diagnostic reagent IVD(2) New Drug Application 2001-09-26 中国人民解放军军事医学科学院基础医学研究所 北京金伟凯医学生物技术有限公司 Certificate Issued 2003-02-11 view