適應症
一種化學冷光微粒免疫分析法(CMIA),用於定性測試人類血清及血漿中對抗弓漿蟲(Toxoplasma gondii)之IgM抗體。  
劑型
 
包裝
6C 20-256C 20-356C 20-016C 20-10 
許可證字號
衛部藥製字第020370號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2029-08-31  
發證日期
2009-08-31  
許可證種類
09 
中文品名
亞培設計師弓漿蟲免疫球蛋白M抗體檢驗試劑組 
英文品名
ABBOTT ARCHITECT Toxo lgM 
藥品類別
C 免疫學及微生物學裝置 
申請商地址
臺北市中山區民生東路3段49號5樓、6樓及51號6樓 
通關簽審文件編號
DHA00602037005 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ABBOTT GMBH MAX-PLANCK-RING 2,65205 WIESBADEN,GERMANY DE
成份表
處方標示 成分名稱 含量 單位
1 ARCHITECT Toxo IgM Reagent kit (100/500 Tests)\nMicroparticles:1 Bottle (6.6 mL per 100-test bottle/27.0 mL per 500-test bottle) anti-human IgM (mouse, monoclonal) antibody coated microparticles in TRIS buffer with protein stabilizers and detergent. Minimum concentration: 0.08% solids. Preservatives: antimicrobial agents.\nConjugate:1 Bottle (5.9 mL per 100-test bottle/26.3 mL per 500-test bottle) conjugate complex consisting of acridinium-labeled anti-Toxoplasma p30 antigen (mouse, monoclonal) antibody and native Toxoplasma gondii lysate in phosphate buffer with protein stabilizers and detergent. Minimum concentration: 25 μg/mL. Preservative: sodium azide.
1 ARCHITECT Toxo IgM Calibrator\n1 Bottles (4.0 mL) of ARCHITECT Toxo IgM Calibrator contains anti-Toxoplasma p30 antigen (human, monoclonal) IgM antibody prepared in recalcified human plasma.\n\nARCHITECT Toxo IgM Controls\n2 Bottles (4.0 mL each) of ARCHITECT Toxo IgM Controls: Negative Control and Positive Control. The controls are at the following concentrations:
1 Control Color Target Anti-Toxo IgM Control Range \n Concentration (Index) (Index)\nCONTROL- Natural N/A < 0.40\nCONTROL+ Natural 1.50 0.75 – 2.25\nControl Color Target Anti-Toxo IgM Control Range \n Concentration (S/CO) (S/CO)\nCONTROL- Natural N/A < 0.67\nCONTROL+ Natural 2.50 1.25 – 3.75