適應症
利用化學冷光免疫分析(CLIA)技術定量測定人體血清或血漿檢體中弓漿蟲專一免疫球蛋白M抗體。  
劑型
 
包裝
#310710:100 test/kit#310711: 0.7 ml x 2 bot 
許可證字號
衛部藥製字第017879號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2027-01-12  
發證日期
2007-01-12  
許可證種類
09 
中文品名
戴思林禮亞尚弓漿蟲免疫球蛋白M檢測試劑組 
英文品名
DiaSorin LIASON Toxo IgM 
藥品類別
C 免疫學及微生物學裝置 
申請商地址
新北市汐止區福德三路369號12樓 
通關簽審文件編號
DHA00601787907 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
DIASORIN ITALIA 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 Magnetic particles:Magnetic particles coated with IgG to human IgM (mouse, monoclonal), BSA, phosphate buffer,<0.1% sodium azide.Calibrator 1:Human serum/plasma containing low Toxoplasma gondii IgM levels, BSA, phosphate buffer, preservatives, an inert yellow dye.Calibrator 2:Human serum/plasma containing high Toxoplasma gondii IgM levels, BSA, phosphate buffer, preservatives, an inert blue dye.Antigen:Inactivated Toxoplasma gondii (RH strain) obtained from ruptured and detergent-extracted trophozoites, BSA, phosphate buffer, preservatives.Specimen dilunet:BSA, phosphate buffer, preservatives, an inert yellow dye.
1 Conjugate:Mouse monoclonal antibodies to Toxoplasma gondii conjugated to an isoluminol derivative, non-specific IgG (mouse monoclonal), foetal calf serum, BSA, phosphate buffer, preservatives, an inert red dye.Negative control:Human serum/plasma without Toxoplasma gondii IgM antibodies, stabilized in PBS buffer, BSA, preservatives.Positive control:Human serum/plasma containing Toxoplasma gondii IgM antibodies, stabilized in PBS buffer, BSA, preservatives, an inert yellow dye.