卡蒂雅TM 組織蛋白抗體檢測試劑組
CaptiaTM Histone

適應症
以酵素免疫吸著分析法半定量檢測人體血清中組織蛋白抗體。  
劑型
 
包裝
#2337770: 96 tests 
許可證字號
衛部藥製字第017280號 
註銷狀態
1 
註銷日期
2012-11-27  
註銷理由
838 
有效日期
2011-08-15  
發證日期
2006-08-15  
許可證種類
09 
中文品名
卡蒂雅TM 組織蛋白抗體檢測試劑組 
英文品名
CaptiaTM Histone 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
晃聖有限公司  
申請商地址
新北市板橋區民生路一段三三號六樓之五 
通關簽審文件編號
DHA00601728007 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
TRINITY BIOTECH USA 2823 GIRTS ROAD JAMESTOWN, NY 14701 US
成份表
處方標示 成分名稱 含量 單位
1 1. Histone antigen coated microassay plate: 96 wells, configured in twelve 1x8 strips.\n2. Serum Diluent Type III: Contains buffer, BSA and Tween-20, and proclin (0.1%) as a preservative.\n3. Control: a) High Positive Control: Human serum or defibrinated plasma. Sodium azide (<0.1%) and pen/strep (0.01%) added as preservatives; b) Low Positive Control: Human serum or defibrinated plasma. Sodium azide (<0.1%) and pen/strep (0.01%) added as preservatives; c) Negative Control: Human serum or defibrinated plasma. Sodium azide (<0.1%) and pen/strep (0.01%) added as preservatives .\n4. Horseradish-peroxidase (HRP) Conjugate: Goat anti-human IgG, IgA, and IgM containing proclin (0.1%) and gentamicin as preservative. \n5. Wash Buffer Type II (20x concentrate): Contains TBS, Tween-80 and proclin (0.1%) as a preservative.\n6. Chromogen/Substrate Solution Type I: Tetramethylbenzidine (TMB).\n
1 7. Calibrator: Human serum or defibrinated plasma, sodium azide (<0.1%) and pen/strep (0.01%) added as preservatives.\n8. Stop Solution: 1N H2SO4 solution. \n