適應症
在體外以免疫分析法定量檢測人類血清和血漿中抗竿地弓漿蟲IgG抗體。  
劑型
 
包裝
# 04618815 190:100 tests, # 04618823 190:16 x 1.0 ml 
許可證字號
衛部藥製字第019463號 
註銷狀態
註銷日期
2015-04-09  
註銷理由
838 
有效日期
2013-10-21  
發證日期
2008-10-21  
許可證種類
09 
中文品名
羅氏免疫分析弓漿蟲免疫球蛋白 G 抗體檢驗試劑 
英文品名
Elecsys Toxo IgG 
藥品類別
C 免疫學及微生物學裝置 
申請商地址
台北市中山區民權東路3段2號10樓 
通關簽審文件編號
DHA00601946302 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 D-68305 MANNHEIM GERMANY DE
成份表
處方標示 成分名稱 含量 單位
1 Toxo IgG\nReagents - working solutions\nM Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles, 0.72 mg/mL; preservative. \nR1 Toxoplasma-Ag~biotin (gray cap), 1 bottle, 9 mL: Biotinylated T. gondii-specific antigen (recombinant, E. coli), > 400 μg/L, Tris buffer 50 mmol/L, pH 7.5; preservative.\nR2 Toxoplasma-Ag~Ru(bpy)2+3 (black cap), bottle, 9 mL: T. gondii-specific antigen (recombinant, E. coli) labeled with ruthenium complex > 400 μg/L; TRIS buffer 50 mmol/L, pH 7.5; preservative.\nCal1 Negative calibrator 1 (white cap), 2 bottles of 1.0 mL each: Human serum, non-reactive for anti-Toxoplasma IgG; buffer; preservative.\nCal2 Positive calibrator 2 (black cap), 2 bottles of 1.0 mL each: Human serum, reactive for anti-Toxoplasma IgG, approx. 100 IU/mL; buffer; preservative.
1 PreciControl Toxo IgG\nReagents - working solutions\n?PC TOXIGG1: 8 bottles, each containing 1.0 mL of control serum Human serum, negative to low positive for Toxo IgG antibodies (approx. 1 IU/mL); preservative.\n?PC TOXIGG2: 8 bottles, each containing 1.0 mL of control serum Human serum, positive for anti-Toxo IgG antibodies (approx. 50 IU/mL); preservative.