羅氏免疫分析毛地黃檢驗試劑

ELECSYS DIGOXIN

衛署醫器輸字第012079號

本站收錄狀態已註銷

有效日期2010 / 08 / 17

醫療器材級數未載明

這張許可證已註銷（2013/01/18，許可證已逾有效期），以下僅供查閱歷史資料。申請商為 台灣羅氏醫療診斷設備股份有限公司。以下整理許可證、規格與製造廠資料，供核對產品身分使用。

許可證資料依公開資料欄位整理

效能: Digoxin reagent-在體外以免疫分析法定量人類血清和血漿中毛地黃素(Digoxin)。
規格: Elecsys Digoxin reagent kit: 100 tests Elecsys Digoxin CalSet: 4×1.5 ml
主成分: (Reagent)M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles, 0.72 mg/mL; binding capacity: 470 ng biotin/mg microparticles; preservative.R1 Anti-digoxin-Ab~Ru(bpy)32+ (gray cap), 1 bottle, 10ml: Monoclonal anti-digoxin antibody (mouse) labeled with ruthenium complex 15 μg/L; monoclonal anti-digoxin antibody (mouse) 5mg/L, phosphate buffer 100 mmol/L, pH 7.0; preservative.R2 Digoxin-dervative~biotin (black cap), 1 bottle, 10ml: Biotinylated digoxigenin 1.06 ng/ml; biotin 15μg/L; phosphate buffer 100 mmol/L, pH 7.0 ; preservative.(CalSet)DIGO Cal1: 2 bottles, each for 1.5mL of calibrator 1DIGO Cal2: 2 bottles, each for 1.5mL of calibrator 2Digoxin in two concentration ranges (approx. 0.61 ng/mL or 0.78 nmol/L and approx. 3.61 ng/mL or 4.62 nmol/L) in a buffer/protein (bovine serum) matrix.

可改用包裝上的完整型號或許可證字號查詢。