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⚠️ 此醫材許可證已註銷

狀態:已註銷 日期:2012/11/27

原因:許可證已逾有效期

"代首林" 睪丸脂酮放射免疫分析試劑

🩺 醫材

"DiaSorin" TESTO-CTK

衛署醫器輸字第017840號

GDP 認證供應商

醫材分類

2 等級
  • A.1680睪固酮試驗系統

醫器規格

#P3093 (100 tests)

限制項目

輸入須附同意書(每次輸入均須取得原子能委員會之同意書為憑);;輸 入

適應症

定量檢測人體血清或血漿中睪丸脂酮的含量。

醫材資訊

主成分
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.
製造商
DIASORIN INC.
製造國
US
申請商
泰歷藥品儀器股份有限公司
有效日期
2011/12/19
發證日期
2006/12/19

供應藥局

目前尚無登錄供應此品項的藥局資料。