適應症
利用放射性免疫定量方法檢測血清中卵泡刺激激素荷爾蒙。  
劑型
 
包裝
DSL-4700 100 tubes、DSL-4700-5 500 tubes 
許可證字號
衛部藥製字第015861號 
註銷狀態
註銷日期
2012-11-26  
註銷理由
838 
有效日期
2011-01-10  
發證日期
2006-01-10  
許可證種類
09 
中文品名
常盈卵泡刺激激素檢驗試劑 
英文品名
DSL FSH IRMA 
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
DHAS0601586102 
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 FSH Standards:One vial, 2.0 mL, labeled A, containing 0 mIU/mL and six vials, 1.0 mL each, labeled B-G, containing concentrations of approximately 1.5, 4.5, 15.0, 45.0, 150.0 and 450.0 mIU/mL FSH (from human pituitary gland) in porcine serum with sodium azide as a preservative.*DSL-4700 (500 Tubes) contains three sets of calibrators.Anti-FSH [I-125] Reagent:One vial, 11 mL each, containing < 10 μCi (370 kBq) of [I-125]-labeled anti-FSH in a protein-based (BSA) buffer with sodium azide as a preservative.*DSL-4700 (500 Tubes) contains five vials of reagent.Anti-FSH-Coated Tubes:One hundred (100) plastic tubes or five hundred plastic tubes with anti-FSH antibody immobilized to the inside wall of each tube. FSH Controls:Two vials, 1.0 mL each, levels I and II, containing low and high concentrations of FSH (from human pituitary gland) in porcine serum with sodium azide as a preservative.Wash Concentrate:One bottle, 100 mL, containing wash concentrate with sodium azide as a preservative.*DSL-4700 (500 Tubes) contai