適應症
利用放射性體外免疫定量方法檢測臨床標本血液/血漿中之IGF-1。  
劑型
 
包裝
DSL-2800: 100 tubes 
許可證字號
衛部藥製字第015862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
常盈胰島素生長因子(IGF-1) 
英文品名
DSL Insulin like growth factor (IGF-1)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
DHAS0601586201 
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. IGF-I Standards: (Lyophilized)Six vials, labeled A-F, containing concentrations of approximately 0,8,30,100,300, and 1000 ng/mL (1.1-130 nmol/L) of IGF-I in a protein-based (BSA) buffer with a non-mercury preservative.B. Anti-IGF-I [I-125] Reagents: (RED)One bottle, 22 mL, containing < 10μCi (370kBq) of [I-125]-labeled anti-IGF-I in a protein –based (BSA) bufferC. Anti-IGF-I Coated Tubes: (METALLIC LIHGT GREEN RIM)One hundred (100) plastic tubes with Anti-IGF-I immunoglobulin immobilized to the inside wall of each tube.D. Sample Diluent:One bottle, 105 mL, containing sample buffer with sodium azide as a preservative.E. Wash Concentrate:One bottle, 60 mL, containing buffer with a non-ionic detergent.F. IGF-I Controls: (Lyophilized)Two vials, Level I and Level II, containing Low and high concentrations of IGF-I in a protein-based (BSA) buffer with non-mercury preservative.