AxSYM B型肝炎表面抗原之抗體檢驗試劑

AxSYM AUSAB

衛署醫器輸字第012068號

本站收錄狀態已註銷

有效日期2017 / 01 / 03

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: 微粒子酵素免疫分析法定性測試人類血清或血漿中之anti-HBs
規格: 100 Tests/Kit
主成分: AxSYM AUSAB reagent Pack*1 Bottle (3.5 ml) Hepatitis B Surface Antigen (Recombinant)(Subtypes ad and ay) Coated Microparticles Minimum concentration:0.05%, 1 Bottle (13.6 ml) Anti-Biotin(Rabbit): Alkaline Phosphatase Conjugate. Minimum concentration: 0.05 ug/ml, 1 Bottle (13.5 ml) Hepatitis B Surface Antigen (Recombinant)(Subtypes ad and ay): Biotin Conjugate. Minimum concentration: 1 ug/ml, 1 Bottle(31.4 ml) Dilution Reagent. Recalcified human plasma, AxSYM AUSAB Standard Calibrator Six bottles (4 ml each) of Standard Calibrators are prepared with recalcified human plasma, AxSYM AUSAB Controls Two bottles (8 ml each) of Controls are prepared with recalcified human plasma, AxSYM AUSAB Dilution Reagent 1 bottle (100ml) AxSYM AUSAB Dilution Reagent are prepared with recalcified human plasma, AxSYM Probe Cleaning Solution 4 bottles (110ml each) containing 2% TEAH, Solution 1 (MUP) 4 bottles (230 ml each) containing 1.2 mM 4-Methylumbelliferyl Phosphate, Solution 3 (Matrix Cell Wash) 4 bottles (1000 ml each) containing 0.3M NaCl in Tris buffer, Solution 4 (10L) containing 0.1M Phosphate Buffer

可改用包裝上的完整型號或許可證字號查詢。