適應症
用於偵測人類血清或血漿中過敏原特異性IgE。  
劑型
 
包裝
# A1000 ; # A1004 ; # A1005 ; # A1100 ; # A9249 ; # A9250 ; # A9251 
許可證字號
衛部藥製字第015537號 
註銷狀態
註銷日期
2012-11-06  
註銷理由
838 
有效日期
2010-12-13  
發證日期
2005-12-13  
許可證種類
09 
中文品名
埃達堤斯過敏原基本檢驗試劑組 
英文品名
Adaltis ALLERgen Basic Kit 
藥品類別
C 免疫學及微生物學裝置 
申請商地址
臺北市松山區南京東路4段16號11樓 
通關簽審文件編號
DHA00601553708 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ADALTIS ITALIA SPA VIA LUIGI EINAUDI, 7-00012 GUIDONIA MONTECELIO (RM), ITALY IT
ADALTIS ITALIA S.P.A. VIA CRISTONI, 12, 40033 CASALECCHIO DI RENO, BOLOGNA (BO), ITALY IT
成份表
處方標示 成分名稱 含量 單位
1 BASIC KIT COMPONENTS:\nIgE MICROPLATE coated with anti-IgE. Each well is coated with monoclonal anti-human IgE.\nHRP-STREPTAVIDIN CONJUGATE:Each vial contains 13 ml of Streptavidin-Peroxidase conjugate in a red colored buffer, pH 5.5 supplemented with 0.001% Proclin 300.\nINCUBATION BUFFER/CALIBRATOR A:Each vial contains 8 ml of TRIS buffer pH8.4, supplemented with 0.005% Proclin300. The incubation buffer of the Basic kit is used as Calibrator A (Conc. 0 KIU/L).\nSUBSTRATE HS:Each vial contains 13ml of a ready-to-use stabilized mixture of 3,3,5,5 tetramethylbenzidine and hydrogen peroxide\nSTOP SOLUTION:Each vial contains 13ml of 0.3M sulphuric acid.\nWASH BUFFER 10x:Each vial contains 100ml of a washing solution, concentrated 10x, with Amphoteric. B 2.5 μg/ml.
1 CALIBRATION SET COMPONENTS:\nThe vials contain 0.75 ml of human IgE in equine serum and 0.01% Proclin 300. The IgE concentrations are: 0.36-0.72-3.6-18-50-100 KIU/L. The incubation buffer of the Basic kit is used as Calibrator A (Conc. 0 KIU/L).\nALLERgen Specific IgE Control Sera ALLERgen Specific IgE Positive Control Serum - Inhalants: Positive for D1, E1, E5, G2, G6, T3, T7, W1, W6\nALLERgen Specific IgE Positive Control Serum - Foods: Positive for F1, F2, F4, F13\nALLERgen Specific IgE Negative Control Serum: Negative for D1, D2, E1, E5, G2, G6, M2, M5, T3, T7, W1, W6, F1, F2, F3, F13