Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | View |
---|---|---|---|---|---|---|---|---|---|---|---|
JXSS0500016 | 乙型肝炎病毒核心抗体诊断试剂盒(化学发光法) | Diagnostic reagent | IVD | Import Drug Application | 2005-06-03 | 索林诊断(集团)有限公司 | DiaSorin SpA | Certificate Completed-Pending Issued | 2006-09-18 | view | |
CYSS0600086 | 乙型肝炎病毒核心抗体诊断试剂盒(化学发光法) | Diagnostic reagent | IVD | Generic Drug | 2006-12-14 | 威海威高生物科技有限公司 | Weihai Weigao BIOTECHNOLOGY Co Ltd | In Approval | 2008-04-25 | view | |
CXSS0500097 | 乙型肝炎病毒核心抗体诊断试剂盒(化学发光法) | Diagnostic reagent | IVD | New Drug Application | 2005-08-24 | 郑州安图绿科生物工程有限公司 | Autobio Diagnostics Co Ltd | Approval Completed-Pending Certificated | view |