亞培AxSYMB型肝炎核心抗體微粒子酵素免疫分析法

AxSYM CORE

衛署醫器輸字第011753號

本站收錄狀態已註銷

有效日期2017 / 01 / 16

醫療器材級數第三等級

這張許可證已註銷（2019/11/18，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定性測試人類血清或血漿中之anti-HBc.
規格: 100 Tests/Kit
主成分: AxSYM Core Reagnet Pack1.1 bottle(4.8ml) Hepatitis B Virus Core Antigen (E. coli,Recombinant) Coated Microparticles Minimum concentration:0.2%2.1 Bottle(12.8ml) Antibody to Hepatitis B Virus Core Antigen (Human):Alkaline Phosphatase Conjugate Minimum concentation:0.05ug/ml3.1 Bottle(4.3ml) Specimen Diluent. Dithiothreitol in Acetate Buffer. Minimum concentration:70mM.4.1 Bottle(4.0 ml) AxSYM Core Index Calibrator prepared with recalcified human plasma.AxSYM Probe Cleaning SolutionTWO Bottles(9 ml each) of AxSYM CORE Controls are prepared with recalcified human plasma.AxSYM Probe Cleaning Solution4 Bottle(110 ml each) AxSYM Probe Cleaning Solution containing 2% Tetraethylammoniumhydroxide. Solution 1 (MUP)4 Bottle(230ml each) Solution 1 (MUP) containing4-Methylumbelliferyl Phosphate,1.2mM, in buffer.Solution 3 (Matrix Cell Wash)4 Bottles (1000ml each) Solution 3 containing 0.3M SodiumChloride in TRIS Buffer.Solution 4 (Line Diluent)1 Bottle (10 L) Solution 4 containing 0.1M Phospha

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