岱安韶韻環孢靈放射免疫分析試劑組
DiaSorin CYCLO-Trac SP-Whole Blood RIA

適應症
利用放射免疫法定量分析人體全血中之環孢靈(Cyclosporin A, Cyclosporine, Sandimmune)。  
劑型
 
包裝
#23000: 200tubes/kit 
許可證字號
衛部藥製字第016235號 
註銷狀態
1 
註銷日期
2018-05-25  
註銷理由
838 
有效日期
2016-03-28  
發證日期
2006-03-28  
許可證種類
09 
中文品名
岱安韶韻環孢靈放射免疫分析試劑組 
英文品名
DiaSorin CYCLO-Trac SP-Whole Blood RIA 
藥品類別
A 臨床化學及臨床毒理學 
申請商名稱
新科化實業有限公司  
申請商地址
台北市中正區忠孝西路一段50號18樓之2 
通關簽審文件編號
DHAS0601623505 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
DIASORIN INC. 1951 NORTHWESTERN AVE. P. O. BOX 285 STILLWATER, MN U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 CYCLO-Trac SP NSB ImmunoSep: Donkey anti-mouse serum/normal mouse serum premix is diluted in phosphate-buffered saline containing 0.08% sodium azide and a surfactant. Blue dye is added.\nCYCLO-Trac SP Calibrators (0-6): Cyclosporine-free serum cotains 0.1% sodium azide and a surfactant. Six cyclosporine calibrators, at nominal concentrations ranging from 0-1200 ng/ml, are prediluted in human serum.\nAnti-CYCLO-Trac SP ImmunoSep: Monoclonal mouse anti-cyclosporine antibody and donkey anti-mouse/normal mouse serum premix is diluted in phosphate-buffered saline containing 0.08% sodium azide and a surfactant.\n125I CYCLO-Trac SP: A derivative of cyclosporine is labeled with iodine-125 and diluted in citrate-EDTA buffer which contains 0.05% sodium azide, human serum and a surfactant. Red dye is added.\nCYCLO-Trac SP Controls (level 1 and level 2): Ranges for each lot are printed on the control vials included with each kit. 0.1% sodium azide and other stabilizers are added.\n