適應症
定量檢測人體血清或血漿中睪丸脂酮的含量。  
劑型
 
包裝
#P3093 (100 tests) 
許可證字號
衛部藥製字第017840號 
註銷狀態
註銷日期
2012-11-27  
註銷理由
838 
有效日期
2011-12-19  
發證日期
2006-12-19  
許可證種類
09 
中文品名
"代首林" 睪丸脂酮放射免疫分析試劑 
英文品名
"DiaSorin" TESTO-CTK 
藥品類別
A 臨床化學及臨床毒理學 
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
DHAS0601784001 
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
成份表
處方標示 成分名稱 含量 單位
1 1.Coated tubes:The inner surface of each tube is coated with testosterone antiserum raised in rabbits. 2.I-125 labeled testosterone (red):the bottle contains 52 mL testosterone labeled with I-125, BSA, phosphate-citrate buffer, preservatives and an inert red dye. Radioactivity is 59 kBq (1.6μCi) or less on the calibration date.3.Testosterone calibrators: Each vial contains steroid-free serum, preservatives and testosterone at the following concentrations:0-0.25-0.5-1.0-2.5-5.0-10.0 ng/mL (0-0.87-1.73-3.47-8.7-17.3-34.7 nmol/L). The zero calibrator vial contains 1 mL in human serum;the 1-6 calibrator vials contain 0.5 mL in newborn calf serum.4.Control serum 1 (lyophilized reagent):The vial contains testosterone, human serum and preservatives. The reference range is reported on the vial label. Reconstitute the vial contents with 1 mL distilled water.