適應症
利用放射性免疫定量方法檢測血清中的生長激素荷爾蒙。  
劑型
 
包裝
DSL-1900: 100 tubes、DSL-1900-5: 500 tubes 
許可證字號
衛部藥製字第015880號 
註銷狀態
註銷日期
2012-11-26  
註銷理由
838 
有效日期
2011-01-17  
發證日期
2006-01-17  
許可證種類
09 
中文品名
常盈人體生長激素檢驗試劑 
英文品名
DSL GH 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
DHAS0601588003 
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 hGH standards:Seven vials, labeled A-G, containing concentrations of approximately:WHO 80/505 Calibration: 0.0, 0.2, 1.2, 2.6, 8.0, 22.0 and 40.0 ng/mL hGH or WHO 88/624 Calibration: 0.0, 0.13, 0.8, 1.7, 5.8, 15.0 and 30.0 ng/mL hGH. The hGH Standards are prepared in human serum with a non-mercury preservative.DSL-1900 (500 Tubes) contains three sets of Standards.Anti-hGH [I-125] Reagent:One bottle, 22 mL, containing <10 μCi (370 kBq) [I-125]-labeled anti-hGH antibody in a protein-based (BSA) buffer with sodium azide as a preservative.DSL-1900 (500 Tubes) contains five bottles of reagent.
1 Anti-hGH [I-125] Reagent:One bottle, 22 mL, containing <10 μCi (370 kBq) [I-125]-labeled anti-hGH antibody in a protein-based (BSA) buffer with sodium azide as a preservative.DSL-1900 (500 Tubes) contains five bottles of reagent.Anti-hGH-Coated Tubes:One hundred (100) plastic tubes with anti-hGH immunoglobulin immobilized to the inside wall of each tube. DSL-1900 (500 Tubes) contains 500 tubes:hGH Controls:Two vials, Levels I and II, containing low and high concentrations of hGH in human serum with a non-mercury preservative.DSL-1900 (500 Tubes) contains three sets of Controls.Wash Concentrate B:One bottle, 60 mL, containing buffered saline with a nonionic detergent. Dilute 25-fold with deionized water prior to use . DSL-1900 (500 Tubes) contains five bottles of Wash Concentrate.