常盈降血鈣素試驗系統
DSL Calcitonin Test System

適應症
利用放射性體外酵素免疫定量方法檢測臨床標本血清血鈣素。  
劑型
 
包裝
DSL- 1200 (100 tubes) 
許可證字號
衛部藥製字第015838號 
註銷狀態
1 
註銷日期
2012-11-26  
註銷理由
838 
有效日期
2011-01-05  
發證日期
2006-01-05  
許可證種類
09 
中文品名
常盈降血鈣素試驗系統 
英文品名
DSL Calcitonin Test System 
藥品類別
A 臨床化學及臨床毒理學 
申請商名稱
常盈實業股份有限公司  
申請商地址
台北市北投區永興路一段49號 
通關簽審文件編號
DHAS0601583804 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BOULEVARD WEBSTER, TEXAS 77598 U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 A. Calcitonin Standards: (Lyophilized)\nOne vial, labeled A, containing 0 pg/mL and five vials, labeled B-F, conaining concentrations of approximately 25, 100, 200, 500 and 1000 pg/mL (7.2-290.0) synthetic human calcitonin in buffer containing protein stabilizer and sodium azide as a preservative. \nB. Ca;citonin [I-125] Reagent: (Lyophilized) (YELLOW)\nOne vial, containing <5 μCi (185 kBq) of [i-125]-labeled human synthetic calctionin in a buffer with a protein stabilizer and sodium azide as a preservative.\nC. Calcitonin antiserum: (Lyophilized) (BLUE)\nOne vial, containing goat anti-human calcitonin serum in a buffer with a protein stabilizer and sodium azide as a preservative.\nD. Precipitating Reagent: (GREEN)\nOne bottle, 100 mL, containing donkey anti-goat gamma globulin, with polyethylene glycol as a precipitating did, and sodium azide as a preservative. \nE. Calcitonin Controls: (Lyophilized)\nTwo vials, levels i and II, containing low and high concentrations of calcitonin with sodium azides as a pre