免疫特 2000 弓漿蟲 免疫球蛋白M試劑
IMMULITE 2000 Toxoplasma IgM Reagent

適應症
用在IMMULITE 2000 分析儀，定量分析成人血清或EDTA，heparin血漿的弓漿蟲(TOXOPLASMA) IgM抗體。  
劑型
 
包裝
200 tests; 600 tests。 
許可證字號
衛部藥製字第013156號 
註銷狀態
1 
註銷日期
2018-05-21  
註銷理由
838 
有效日期
2015-10-11  
發證日期
2005-10-11  
許可證種類
09 
中文品名
免疫特 2000 弓漿蟲 免疫球蛋白M試劑 
英文品名
IMMULITE 2000 Toxoplasma IgM Reagent 
藥品類別
C 免疫學及微生物學用裝置 
申請商名稱
西門子醫療設備股份有限公司  
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
DHA00601315602 
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 Reagents:\nWith barcode. 200 beads, coated with partially purified Toxoplasma gondii antigen (inactivated RH strain tachyzoites purified from mouse peritoneum). 11.5 mL buffer solution containing goat anti-human IgG, with preservative. 11.5 mL alkaline phosphatase (bovine calf intestine) conjugated to polyclonal goat anti-human IgM antibody in buffer, with preservative. One vial of lyophilized human serum with IgM reactive to Toxoplasma, in buffer, with preservative. One vial negative control containing lyophilized human serum nonreactive to Toxoplasma, in IMMULITE 2000 IgG/IgM Sample Diluent, with preservative. One vial positive control containing lyophilized human serum with IgM reactive to Toxoplasma in IMMULITE 2000 IgG/IgM Sample Diluent, with preservative. Concentrated (ready-to use) nonhuman protein/buffer matrix, with preservative.