邦迪斯人類免疫球蛋白質 G 亞型套組使用於 Beckman Immage / Immage 800 Analyser
HUMAN IgG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE / IMMAGE 800 ANALYSER

適應症
定量血清中人類的免疫球蛋白質G亞型(IgG subclass) 1,2,3,4，適用的機台為Beckman Immage與Backman Immage 800。  
劑型
 
包裝
NK006.IM,IgG1 Beckman IMMAGE kitNK007.IM,IgG2 Beckman IMMAGE kitLK008.IM,IgG3 Beckman IMMAGE latex kitLK009.IM,IgG4 Beckman IMMAGE latex kit 
許可證字號
衛部藥製字第018263號 
註銷狀態
0 
註銷日期
 
註銷理由
 
有效日期
2027-05-02  
發證日期
2007-05-02  
許可證種類
09 
中文品名
邦迪斯人類免疫球蛋白質 G 亞型套組使用於 Beckman Immage / Immage 800 Analyser 
英文品名
HUMAN IgG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE / IMMAGE 800 ANALYSER 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
太暘生物科技股份有限公司  
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
DHA00601826302 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
THE BINDING SITE GROUP LIMITED 8 CALTHORPE ROAD, EDGBASTON, BIRMINGHAM B15 1QT, UNITED KINGDOM GB
成份表
處方標示 成分名稱 含量 單位
1 1.Human IgG1 & IgG2 Antisera. There antibodies have been adsorbed to be monospecific for the relevant subclass and are supplied in stablised liquid form. They contain 0.099% sodium azide and 0.5% BSA, 0.1% E-amino-n-caproic acid (EACA) and 0.01% benzamidine as preservatives.\n2.Human IgG3 & IgG4 Reagent. These latex reagents are monospecific for the relevant subclass and are supplied in stabilized liquid form. They contain 0.099% sodium azide as a preservative.\n3.Calibrators and Controls. These consist of delipidated, pooled normal human serum and are supplied in stabilised liquid form. They contain 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives.\n4.Reaction Accelerator. Contains 0.099% sodium azide as a preservative.\n