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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
Y0401449 癌胚抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2004-08-19 郑州绿科生物工程有限公司 Certificate Issued 2004-12-20 view
X0306861 癌抗原125化学发光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2004-09-09 郑州绿科生物工程有限公司 Certificate Issued 2005-03-04 view
Y0401448 甲胎蛋白诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2004-08-19 郑州绿科生物工程有限公司 Certificate Issued 2004-12-20 view
X0305710 甲胎蛋白化学发光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2004-09-09 郑州绿科生物工程有限公司 Certificate Issued 2005-11-07 view
X0401087 甲状腺素化学发光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2004-11-30 郑州绿科生物工程有限公司 Certificate Issued 2005-06-08 view
FS20010016 梅毒甲苯胺红不加热血清实验诊断试剂 Diagnostic reagent IVD Generic Drug 2001-08-10 郑州绿科生物工程有限公司 Approval Completed-Pending Certificated 2002-02-20 view
CSS00071 梅毒特异性抗体胶体金检测试剂盒 Diagnostic reagent IVD(3) New Drug Application 2000-09-29 郑州绿科生物工程有限公司 Certificate Issued 2002-03-11 view
X0306846 催乳素化学发光检测试剂盒 Diagnostic reagent IVD New Drug Application 2004-09-09 郑州绿科生物工程有限公司 Certificate Issued 2005-03-03 view
X0306865 促甲状腺激素化学发光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2004-09-09 郑州绿科生物工程有限公司 Certificate Issued 2005-02-21 view
CSS20020046 人类免疫缺陷病毒抗体诊断试剂盒(胶体金法) Diagnostic reagent IVD(3) New Drug Application 2002-08-16 郑州绿科生物工程有限公司 Certificate Issued 2003-09-05 view
FS20010013 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 2001-08-10 郑州绿科生物工程有限公司 Approval Completed-Pending Certificated 2001-12-27 view
X0401789 乙型肝炎病毒表面抗原化学发光免疫诊断试剂盒 Diagnostic reagent IVD New Drug Application 2004-04-19 郑州绿科生物工程有限公司 Certificate Issued 2006-12-05 view
FS20010015 乙型肝炎病毒表面抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2001-08-10 郑州绿科生物工程有限公司 Approval Completed-Pending Certificated 2001-12-27 view
FS20010014 乙型肝炎病毒核心抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2001-08-10 郑州绿科生物工程有限公司 Approval Completed-Pending Certificated 2001-12-27 view
FS20010017 乙型肝炎病毒e抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2001-08-10 郑州绿科生物工程有限公司 Approval Completed-Pending Certificated 2001-12-27 view
FS20010018 乙型肝炎病毒e抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2001-08-10 郑州绿科生物工程有限公司 Approval Completed-Pending Certificated 2001-12-27 view
FS20010019 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2001-08-10 郑州绿科生物工程有限公司 Approval Completed-Pending Certificated 2001-12-27 view