適應症
定量測定人體血清中的阿爾發胎兒蛋白。  
劑型
 
包裝
DSL-10-4800:96 WELLS/SET 
許可證字號
衛部藥製字第016447號 
註銷狀態
註銷日期
2013-01-18  
註銷理由
838 
有效日期
2011-04-21  
發證日期
2006-04-21  
許可證種類
09 
中文品名
迪斯爾胎兒甲蛋白酵素免疫分析套組 
英文品名
DSL AFP ELISA 
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
DHA00601644702 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BOULEVARD WEBSTER, TEXAS 77598 U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 Anti-AFP-Coated Microtitration Strips:\nOne stripholder containing 96 microtitration wells coated with anti-AFP antibody.\nAFP Standard A / Sample Diluent:\nContaining 0 ng/mL AFP in a protein-based (BSA) buffer with a non-mercury preservative. \nAFP Standards B-F:\nContaining concentrations of approximately 5, 20, 100, 200 and 500 ng/mL AFP in a protein-based (BSA) buffer with a non-mercury preservative. \nAFP Controls:\nContaining low and high concentrations of AFP in a protein-based (BSA) buffer with a non-mercury preservative.\nAssay Buffer: (GREEN)\nContaining a protein-based buffer with a non-mercury preservative. \nAFP Antibody-Enzyme Conjugate Concentrate:\nContaining anti-AFP antibody conjugated to the enzyme horseradish peroxidase in a protein-based (BSA) buffer with a non-mercury preservative. \nTMB Chromogen Solution:\nContaining a solution of tetramethylbenzidine (TMB) in citrate buffer with hydrogen peroxide.\nWash Concentrate:\nContaining buffered saline with a nonionic detergent.\nStopping S