適應症
被動粒子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 (20x5)、220T/KIT (55x4)。 
許可證字號
衛部藥製字第015514號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2025-12-13  
發證日期
2005-12-13  
許可證種類
09 
中文品名
速樂定 TPPA 檢驗試劑 
英文品名
SERODIA-TPPA 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
育聖企業有限公司  
申請商地址
新北市板橋區民生路一段33號6樓之4 
通關簽審文件編號
DHA00601551409 
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) : Use for reconstitution of Sensitized Particles and Unsensitized Particles. This reagent contains 0.06% (W/V) Sodium Azide per vial as preservative.\n(B.) Sample Diluent (Liquid) : Use for dilution of Specimens. This reagent contains 0.10% (W/V) Sodium Azide per vial as preservative. \n(C.) Sensitized Particles (Lyophilized) : Lyophilized preparation of gelatin particles coated with Treponema Pallidum. Reconstituted by adding prescribed quantity of Reconstituting Solution. The reconstituted solution contains 0.08% (W/V) Sodium Azide per vial as preservative.
1 (D.) Unsensitized Particles (Lyophilized) : Lyophilized preparation of tanned gelatin particles. Reconstituted by adding prescribed quantity of Reconstituting Solution. The reconstituted solution contains 0.08% (W/V) Sodium Azide per vial as preservative. \n(E.) Positive Control (Liquid) : This control is prepared from rabbit serum containing antibodies to T. Pallidum. The control should show a titer of 1:320 (Final Dilution). This reagent contains 0.10% (W/V) Sodium Azide per vial as preservative.