適應症
定量檢測人體血清或血漿中抗thyroglobulin (IgG to hTg)自體抗體的含量。  
劑型
 
包裝
#P000172 (100 tests) 
許可證字號
衛部藥製字第017874號 
註銷狀態
註銷日期
2014-04-15  
註銷理由
838 
有效日期
2012-01-11  
發證日期
2007-01-11  
許可證種類
09 
中文品名
"代首林" 甲狀腺球蛋白抗體放射免疫分析試劑 
英文品名
"DiaSorin" AB-HTGK-3 
藥品類別
C 免疫學及微生物學裝置 
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
DHAS0601787405 
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: 100 tubes, the inner surface of each tube is coated with highly purified biotinylated hTg.2.125I tracer (red):The vial contains 52 mL protein A labeled with 125I, BSA, phosphate-citrate buffer, preservatives and an inert red dye. Radioactivity is 296 kBq (8μCi).3.Anti-thyroglobulin calibrators:Each vial contains 0.5 mL of prediluted human serum containing IgG to hTg, calf serum, BSA, PBS buffer and preservatives. The calibrator concentrations are the following:0-100-200-500-1500-6500 IU/mL, 6 vials.4.Control serum:the vial contains prediluted human serum, anti-hTg antibodies, calf serum, BSA, PBS buffer and preservatives.5.Sample diluent:Each bottle contains 50 mL PBS buffer, calf serum, BSA and preservatives. 2 bottles.6.Incubation buffer (blue):The bottle contains 52 mL TRIS buffer solution, BSA, detergents, preservatives and an inert blue dye.
1 7.Wash buffer:reagent in solution (10x). Each bottle contains 50 mL 0.5% Triton X-100 and saline solution. Diluent the contents of each bottle to 500 mL with deionized water . 2 bottles.