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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
第 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。