日富-快速便潛血檢驗試劑
IMMUDIA Hem Sp

適應症
被動血球凝集法檢測人糞便(Feces)中之Hemoglobin(血色素)  
劑型
 
包裝
80Tests / Kit (10 x 8), 480Tests / Kit ( 60 x 8) 
許可證字號
衛部藥製字第016024號 
註銷狀態
1 
註銷日期
2018-05-17  
註銷理由
838 
有效日期
2016-02-20  
發證日期
2006-02-20  
許可證種類
09 
中文品名
日富-快速便潛血檢驗試劑 
英文品名
IMMUDIA Hem Sp 
藥品類別
B 血液學及病理學裝置 
申請商名稱
台富製藥股份有限公司  
申請商地址
桃園市大園區和平西路一段 ３９１號 
通關簽審文件編號
DHA00601602400 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
FUJIREBIO INC., HACHIOJI FACILITY 51, KOMIYA-CHO, HACHIOJI-SHI TOKYO, 192-0031 JAPAN JP
成份表
處方標示 成分名稱 含量 單位
1 Each Kit contains: 80Tests / Kit 480Tests / Kit (B) Specimen Diluent (Liquid): 35mL x 2 vials 190mL x 2 vials Use as an extract and dilution of Specimens, And also for the reconstitution of the Antibody- Sensitized Cells and Hb Reactive Control.(C) Antibody-Sensitized Cells (Lyophilized): 0.6mL* x 8 vials 3.2mL* x 8 vials Lyophilized preparation of chicken erythrocytes (*After Reconstitution)sensitized with Anti-Hb specific antibody. Reconstituted by adding prescribed quantity of the Specimen Diluent at the time of use( produces1.2﹪Suspension after reconstitution) (E) Hb Reactive Control) (Lyophilized): 0.5mL* x 1vial 0.5mL* x 1vial Lyophilized preparation of hemoglobin which was prepared (*After Reconstitution) To produce antigen titer equivalent to 1:8 ﹝23﹞specimen dilution after reconstitution. Reconstituted by adding prescribed quantity of the Specimen Dilution at the time of