適應症
Reagent Kit, 100 Tests/400 Tests/200 Tests  
劑型
 
包裝
7K72-01、7K72-10、7K72-50 
許可證字號
衛部藥製字第012457號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2025-09-20  
發證日期
2005-09-20  
許可證種類
09 
中文品名
亞培"設計師"雌二醇檢驗試劑組校正液及品管液 
英文品名
ABBOTT ARCHITECT Estradiol Calibrators and Controls 
藥品類別
A 臨床化學及臨床毒理學用裝置 
申請商地址
臺北市中山區民生東路3段49號5樓、6樓及51號6樓 
通關簽審文件編號
DHA00601245708 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ABBOTT IRELAND DIAGNOSTICS DIVISION LISNAMUCK, LONGFORD, CO. LONGFORD, IRELAND IE
成份表
處方標示 成分名稱 含量 單位
1 Reagent Kit, 100 Tests/400 Tests/2000 TestsARCHITECT Estradiol Reagent KitMICROPARTICLES1 OR 4 Bottle(s) (9.9ml) Anti-Estradiol (rabbit, monocional) coated Microparticels in TAIS/BIS-TRIS buffer with protein(rabbit)stabilizers. Mininum concenlration:0.0657% sollds.CONJUGATE1 OR 4 Bottle(s) (5.9ml) Estradiol acndinium-labeled Conjugale in citrate buffer with surfactanl stabilizers. Minimum concentration:63.63ng/mlASSAY DILUENT 1 OR 4 Bottle(s) (5.9ml) Estradiol Assay Diluent containing surfactant in citrate buffer.SPECIMENT DILUENT1 OR 4 Bottle(s) (10.0ml) Estradiol Specimen Diluent conlaining TAIS buffer with protein (bovine) stabilizers.ARCHITECT Estradiol Manual Diluent1 Bottle (5 ml) of ARCHITECT Estradiol Manual Diluent contains TRIS buffer with protein (bovine) stabilizers.ARCHITECT Estradiol Controls (concentration: 45, 190, 600 pg/mL)CONTENTS3 Bottles (8ml) of ARCHITECT Estradiol Controls contain in TRIS buffer with protein (bovine) stabilizers.ARCHITECT Estradiol Cali