適應症
提供血清中AFP的定量測定。  
劑型
 
包裝
DSL 10--8400:96 wells 
許可證字號
衛部藥製字第016221號 
註銷狀態
註銷日期
2012-11-26  
註銷理由
838 
有效日期
2011-03-27  
發證日期
2006-03-27  
許可證種類
09 
中文品名
常盈甲型胎兒蛋白酵素免疫連結分析法 
英文品名
DSL ACTIVE AFP ELISA 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
常盈實業股份有限公司  
申請商地址
台北市北投區永興路一段49號 
通關簽審文件編號
DHA00601622102 
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:\nOne bottle, 5.0 mL, labeled A, containing 0 ng/mL AFP in a protein-based (BSA) buffer with a non-mercury preservative.\nAFP Standard B-F:\nFive vials, 0.6 mL each, labeled B-F, containing 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:\nTwo vials, 0.6 mL each, Levels I and II, containing low and high concentrations of AFP in a protein-based (BSA) buffer with a non-mercury preservative.\nAssay Buffer : (GREEN)\nOne bottle, 2.8 mL, containing a protein-based buffer with a non-mercury preservative.\nAFP Antibody-Enzyme Conjugate Concentrate:\nOne vial, 0.5 mL, containing anti-AFP antibody conjugated to the enzyme horseradish peroxidase in a protein-based (BSA) buffer with a non-mercury preservative. Dilute prior to use in Assay Buffer A.\nTMB Chromogen Solution