亞培愛可信毛地黃第二代檢驗試劑組

ABBOTT AxSYM Digoxin II

衛署醫器輸字第012452號

本站收錄狀態已註銷

有效日期2015 / 09 / 20

醫療器材級數第二等級

這張許可證已註銷（2018/08/09，未展延而逾期者），以下僅供查閱歷史資料。申請商為 美商亞培股份有限公司台灣分公司。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: 微粒酵素免疫分析法測試人體血清或血漿中之digoxin.
規格: 100 Tests
主成分: AxSYM Digoxin II Reagent Pack1. 1 Bottle (15.0mL) Digoxin: Alkaline Phospahtase. Minimum concentration: 0.05μg/mL.2. 1 Bottle (7.6mL) Anti-digoxin coated Microparticels. Minimum concentration: 0.0001%. Preservative: Sodium Azide.3. 1 Bottle (27mL) EMIA buffer containing 0.3M Sodium Chloride in TRIS buffer. 4. 1 Bottle (41.9mL) Digoxin II Probe Wash Solution containing a 2.0 M Sodium Chloride solution.Digoxin Calibrators 6 Bottles (6mL A, 4mL each B-F) of Digoxin Calibrators contain accurately measured amounts of digoxin prepared in recalcified human plasma, nonreactive for HbsAg, HIV-1 Ag, anti-HCV, and anti-HIV-1/HIV-2 yield the following concentrations: 0, 0.5, 1.0, 2.0, 3.0 and 4.0 ng/mL.Digoxin Controls 3 Bottels (8mL each) of Digoxin control cotain accurately measured amounts of digoxin prepared in recalcified human plasma, nonreactive for HbsAg, HIV-1 Ag, anti-HCV, and anti-HIV-1/HIV-2 to yield the following concentration ranges: 0.9, 1.9 and 3.2 ng/mL.

可改用包裝上的完整型號或許可證字號查詢。