適應症
在BN系統上,定量測量血漿中凝血因子抗凝血酵素III。  
劑型
 
包裝
OSAY09:2mL 
許可證字號
衛部藥製字第016122號 
註銷狀態
註銷日期
2023-08-04  
註銷理由
838 
有效日期
2021-03-10  
發證日期
2006-03-10  
許可證種類
09 
中文品名
"西門子" N 抗人類凝血酵素Ⅲ抗血清試劑 
英文品名
"Siemens"N Antiserum to Human-Antithrombin III 
藥品類別
B 血液學及病理學裝置 
申請商地址
臺北市南港區園區街3號2樓之2 
通關簽審文件編號
DHA00601612200 
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 N Antisera are liquid animals sera and are produced by immunization of rabbits with highly purified human fibrinogen, antithrombin III, plasminogen, or C1 Inhibitor, Labile components are removed from the antisera by a special procedure. Microbial contamination is essentially excluded by filtration and addition of sodium azide as a preservative (<1g/L). After solid phase immunoadsorption, the purified, specific antisera are specially tested and adjusted for optimal suitability for use on the BN* Systems. The antibody titers (T) are determined by radial immunodiffusion and are printed on the vial labels. The titers are indicate the quantity of antigen in mg which will be precipated in an agarose gel by 1 mL of the corresponding antiserum.