適應症
使用化學冷光免疫分析(CLIA)技術以定量測定人體血清或血漿檢體中的hCMV專一免疫球蛋白M抗體。  
劑型
 
包裝
#310750: 100 tests/kit#310751: 0.7ml x 2 bottles 
許可證字號
衛部藥製字第017824號 
註銷狀態
註銷日期
2018-05-28  
註銷理由
838 
有效日期
2016-12-07  
發證日期
2006-12-07  
許可證種類
09 
中文品名
戴思林禮亞尚巨細胞病毒免疫球蛋白M檢測試劑及品管組 
英文品名
DiaSorin LIAISON CMV IgM & LIAISON Control CMV IgM 
藥品類別
C 免疫學及微生物學裝置 
申請商地址
新北市汐止區康寧街169巷25號13樓 
通關簽審文件編號
DHA00601782408 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
DIASORIN 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 Reagent integral\n Magnetic particles (2.3mL): Magnetic particles coated with inactivated hCMV antigen (AD 169 strain), BSA, phosphate buffer, <0.1% sodium azide.\n Calibrator 1 (2.3mL): Human serum/plasma containing low hCMV IgM levels, BSA, phosphate buffer, preservatives, an inert yellow dye.\n Calibrator 2 (2.3mL): Human serum/plasma containing high hCMV IgM levels, BSA, phosphate buffer, preservatives, an inert blue dye.\n Buffer A (25mL): Goat IgG to human IgG (absorbent reagent), goat serum, BSA, phosphate buffer, preservatives, an inert blue dye. \n Specimen diluent (28mL): BSA, phosphate buffer, preservatives, an inert yellow dye.\n Conjugate (23mL): Mouse monoclonal antibodies to human IgM conjugated to an isoluminol derivative, non-specific IgG (mouse monoclonal), BSA, phosphate buffer, preservatives. \n \nNegative control (0.7 mL): Human serum/plasma without CMV IgM antibodies, stabilized in PBS buffer, BSA, preservatives. \nPositive control (0.7mL): Human serum/plasma containing