“代首林”人體生長激素放射免疫分析試劑
"DiaSorin"HGH-CTK IRMA

適應症
定量檢測人體血清或血漿檢體中之生長激素(hGH)。  
劑型
 
包裝
#P2244: 100TUBES 
許可證字號
衛部藥製字第016283號 
註銷狀態
1 
註銷日期
2012-11-27  
註銷理由
838 
有效日期
2011-03-31  
發證日期
2006-03-31  
許可證種類
09 
中文品名
“代首林”人體生長激素放射免疫分析試劑 
英文品名
"DiaSorin"HGH-CTK IRMA 
藥品類別
A 臨床化學及臨床毒理學 
申請商名稱
泰歷藥品儀器股份有限公司  
申請商地址
台北市大同區承德路二段81號15樓 
通關簽審文件編號
DHAS0601628303 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
DIASORIN INC. 1951 NORTHWESTERN AVE. P. O. BOX 285 STILLWATER, MN U.S.A. US
DIASORIN S.P.A. VIA CRESCENTINO SNC, 13040 SALUGGIA (VC), ITALY IT
成份表
處方標示 成分名稱 含量 單位
1 1. Coated tubes: 100 tubes. The inner surface of each tube is coated with biotinylated IgG to hGH (mouse monoclonal) directed against an hGH epitope\n2. I-125 tracer: 1 vial. The vial contains 11 ml IgG to hGH (mouse monoclonal) labeled with I-125, BSA, horse serum, mouse IgG, phosphate buffer, preservatives and in insert red dye. Radioactivity is 333 KBq (9 μCi).\n3. hGH calibrators: 7 vials. The vials contain increasing amounts of hGH , human serum, phosphate buffer and preservatives. hGH concentrations are as follows: 0, 1, 3, 6, 16, 40, 100 μIU/ml (0, 0.5, 1.5, 3, 8, 20, 50 ng/ml).\n4. Control serum: 1 vial lyophilized reagent. The vial contains hGH, human serum, phosphate buffered and preservatives. \n5. Wash Buffer: 2 bottles. Each bottle contains 50 ml 0.5% Triton X-100 and saline solution.\n