適應症
血球凝集法檢測人血清及血漿中之梅毒Treponema Pallidum抗體。  
劑型
 
包裝
100T/Kit (25×4)、500T/KIT( 100×5) 
許可證字號
衛部藥製字第015462號 
註銷狀態
註銷日期
2016-03-22  
註銷理由
841 
有效日期
2015-12-12  
發證日期
2005-12-12  
許可證種類
09 
中文品名
速樂定TP檢驗試劑 
英文品名
SERODIA-TP 
藥品類別
C 免疫學及微生物學裝置 
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
DHA00601546203 
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 (A.) RECONSTITUTING SOLUTION (Liquid) : \nThis reagent is used for reconstitution of lyophilized Sensitized Cells and Un sensitized Cells,and consists of a phosphate buffered saline solution containing Normal rabbit serum and Sodium Azide (0.1﹪).\n(B.) SERUM DILUENT (Liquid): \nThis reagent is used for dilution of test serum and reconstitution of Serodia-HAAbsorbent and consists of a phosphate buffered saline solution containing Normal rabbit testicular extract,cell components of sonicated Reiter T. Phagedenis, normal rabbit serum and Sodium Azide (0.1﹪).\n(C.) SENSITIZED CELLS (Lyophilized)\nFixed chicken erythrocytes sensitized with components of pathogenic\nTreponema Pallidum(Nichols Strain). Each vial must be rehydrated withthe prescribed quantity of Reconstituting Solution( to obtain 0.375% suspension) before utilization.\n(D.) UNSENSITIZED CELLS (Lyophilized)\nFixed chicken erythrocytes. The reagent of each vial must be rehydrated with the prescribed quantity of Reconstituting Solution ( to obtain 0.37
1 (E.) POSITIVE CONTROL (Liquid) : \nThis control is prepared from rabbit serum containing T. Pallidum and Sodium Azide (0.1﹪). The control should show a titer of 1:320 (Final Dilution).\n(F.) SERODIA-HA ABSOBENT (Lyophilized)\nUse for absorption of test sera which showed agglutination with unsensitized Cells The reagent must be rehydrated with the prescribed quantity of SERUM DILUENT.