適應症
應用於評估人類全血檢體中的內毒素活性。  
劑型
 
包裝
EA-5001B 3 EAA Trays 1 EAA Quality Control Tray 2 EAA Reagent BottlesEA-5003B 2 EAA Trays 2 EAA Quality Control Trays 2 EAA Reagent Bottles 
許可證字號
衛部藥製字第012449號 
註銷狀態
註銷日期
2012-11-20  
註銷理由
838 
有效日期
2010-09-20  
發證日期
2005-09-20  
許可證種類
09 
中文品名
福島內毒素活性分析試劑 
英文品名
Spectral Endotoxin Activity Assay 
藥品類別
C 免疫學及微生物學用裝置 
申請商名稱
福島醫療器材有限公司  
申請商地址
新北市鶯歌區國慶街26號 
通關簽審文件編號
DHA00601244909 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
SPECTRAL DIAGNOSTICS INC. 135 THE WEST MALL, TORONTO, ONTARIO, CANADA M9C1C2 CA
成份表
處方標示 成分名稱 含量 單位
1 EEA Tray:? 10 tubes containing stabilizers and luminol-zymosan (Tube 1)? 10 tubes containing 1.0-2.0 μg of murine monoclonal anti-endotoxin antibody, stabilizers and luminol-zymosan (Tube 2)? 10 tubes containing 1.0-2.0 μg of murine monoclonal anti-endotoxin antibody, stabilizers and luminol-zymosan (Tube 3)? 5 tubes containing 2.3 ng of endotoxin (E coli 055:B5) with stabilizers (LPS MAX Tube)? 5 empty tubes (Aliquot Tube)EAA Quality Control Tray:? 10 tubes containing stabilizers and luminol-zymosan (Tube 1)? 10 tubes containing 1.0-2.0μg of murine monoclonal anti-endotoxin antibody, stabilizers and luminol-zymosan (Tube 3)? 5 tubes containing endotoxin (E coli 055:B5) with stabilizers (QC LPS MAX Tube)? 5 tubes containing 1.0-2.0 μg of murine monoclonal anti-endotoxin antibody, stabilizers and luminol-zymosan (High Control Tube)? 5 tubes containing 1.0-2.0 μg murine monoclonal antibody, stabilizers and luminol-zymosan (Low Control Tube)? 5 empty tubes (QC Aliquot Tube)EAA Reagent B