適應症
以呈色法定量人類血漿中第8因子(抗血友病因子)的活性。  
劑型
 
包裝
Facotr VIII Chromogenic Assay 測試組.2×2ml Factor X Reagent2×2ml Factor IXa Reagent2×1ml Substrate Reagent 2×10ml Stopping Buffer 
許可證字號
衛部藥製字第012314號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2025-09-12  
發證日期
2005-09-12  
許可證種類
09 
中文品名
戴德凝固因子八 比色分析試劑 
英文品名
Factor VIII Chromogenic Assay 
藥品類別
B 血液學及病理學用裝置 
申請商地址
新北市板橋區深丘里中山路一段156號18樓 
通關簽審文件編號
DHA00601231402 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH EMIL-VON-BEHRING-STR. 76, D-35041 MARBURG, GERMANY DE
成份表
處方標示 成分名稱 含量 單位
1 Reagent:Factor X Reagent: lyophilized preparation containing approximately 2 nmol of bovine F.X, tris-(hydroxymethyle)-aminomethan (Tris) Buffer at pH 8 and stabilizers.Factor Ixa Reagent: lyophilized preparation containing approximately 0.6 nmol Bovine F. Ixa, approximately 0.6 nmol of bovine thrombin, approximately 0.06 mmol of calcium chloride, approximately 0.12 umol of phospholipids, Tris buffer at pH 8 and stabilizers.Substrate Reagent: lyophilized preparation containing approximately 3.4μmol of CH3OCO-D-CHG-Gly-Arg-pNA. AcOh, a F.XaSubstrate, Nα-(2-Naphthylsulfonylglycyl) -D, L amidino-phenylala-ninepiperidide(α-NAPAP), 6 a thrombin inhibitor and stabilizers.Stopping Buffer: solution containing Tris, ethylendiamintetraacetic acid, sodium chloride and 0.02% sodium azide.