適應症
化學冷光免疫分析(CLIA)技術以定量測定人體血清或血漿檢體中弓漿蟲專一免疫球蛋白G抗體。  
劑型
 
包裝
#310700:100 test/kit,#310701 :0.6ml 
許可證字號
衛部藥製字第017906號 
註銷狀態
註銷日期
2014-04-03  
註銷理由
838 
有效日期
2012-02-06  
發證日期
2007-02-06  
許可證種類
09 
中文品名
戴思林禮亞尚弓漿蟲免疫球蛋白G檢測試劑及品管組 
英文品名
DiaSorin LIAISON Toxo IgG & LIAISON Control Toxo IgG 
藥品類別
C 免疫學及微生物學裝置 
申請商地址
新北市汐止區康寧街169巷25號13樓 
通關簽審文件編號
DHA00601790600 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
DIASORIN S.P.A. VIA CRESCENTINO SNC, 13040 SALUGGIA (VC), ITALY IT
成份表
處方標示 成分名稱 含量 單位
1 #310700:\nMagnetic particles (2.3mL) : Magnetic particles coated with inactivated Toxoplasma gondii (RH strain) obtained from sonicated and detergent-extracted trophozoites, BSA, phosphate buffer,<0.1% sodium azide.\nCalibrator 1 (2.7mL ): Human serum/plasma containing low Toxoplasma gondii IgG levels, BSA, phosphate buffer, preservatives, an inert yellow dye.\nCalibrator 2 (2.7mL) : Human serum/plasma containing high Toxoplasma gondii IgG levels, BSA, phosphate buffer, preservatives, an inert blue dye.\nSpecimen diluent (2X28mL) : BSA, phosphate buffer, preservatives, an inert yellow dye.\nConjugate (28mL) : Mouse monoclonal antibodies to human IgG conjugated to an isoluminol derivative, BSA, phosphate buffer, preservatives.\n\n#310701:\nNegative control (0.6mL) : Human serum/ plasma without Toxoplasma gondii IgG antibodies, stabilized in PBS buffer, BSA, preservatives.\nPositive control (0.6mL) : Human serum/ plasma containing Toxoplasma gondii IgG antibodies, stabilized in PBS buffer, BSA, preservatives,