適應症
定量分析成人血清的弓漿蟲 Toxoplasma IgG 抗體。  
劑型
 
包裝
LKTXP1:100 tests, 註銷規格:LKTXP5:500 tests。 
許可證字號
衛部藥製字第013489號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2025-11-04  
發證日期
2005-11-04  
許可證種類
09 
中文品名
免疫特 弓漿蟲定量免疫球蛋白 G 試劑 
英文品名
IMMULITE Toxoplasma Quantitative IgG Reagent 
藥品類別
C 免疫學及微生物學用裝置 
申請商地址
臺北市南港區園區街3號2樓之2 
通關簽審文件編號
DHA00601348900 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED GLYN RHONWY LLANBERIS, CAERNARFON GWYNEDD LL55 4EL UNITED KINGDOM GB
成份表
處方標示 成分名稱 含量 單位
1 Toxoplasma Quantitative IgG Test Units: bead coated with inactivated, partially purified Toxoplasma gondii antigen (RH strain tachyzoites from mouse peritoneum). Toxoplasma Quantitative IgG Reagent Wedges: A: 7.5 mL of a protein-based buffer, with preservative. B: 7.5 mL alkaline phosphatase (bovine calf intestine) conjugated to monoclonal murine anti-human IgG antibody in buffer, with preservative. Toxoplasma Quantitative IgG Adjustors: Two vials (Low and High), 4 mL each, of human serum with IgG reactive to toxoplasma, in buffer, with preservative. Toxoplasma Quantitative IgG Controls: Negative Control: containing human serum with IgG nonreactive to toxoplasma, with preservative. Low Positive Control, Positive Control: containing human serum with IgG reactive to toxoplasma, with preservative. IgG/IgM Sample Diluent: 100 mL nonhuman protein/buffer matrix, with preservative.