亞培AxSYM C型肝炎檢驗試劑第三代

Abbott AxSYM HCV 3.0

衛署醫器輸字第011752號

本站收錄狀態已註銷

有效日期2018 / 07 / 31

醫療器材級數第三等級

這張許可證已註銷（2022/07/15，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體血清或血漿中之Anti-HCV
規格: 100 Tests/Kit。規格變更為：3B44-10、3B44-20。
主成分: AxSYM HCV version 3.0 Reagent Pack 1 bottle(9.9ml) HCV Antigen Coated Microparticles 1 bottle(12.1ml) Goat Anti-Human IgG:Alkaline Phosphatase Conjugate 1 bottle(28ml) Specimen Diluent 2 1 bottle(50.2ml) Specimen Diluent 1 1 bottle(2.0ml) AxSYM HCV 3.0 Index Calibrator. Recalcified human plasma,reactive for anti-HCV and nonreactive for HBsAg and anti-HIV-1/HIV-2)AxSYM HCV version 3.0 Controls Two bottles (7ml each) of AxSYM HCV version 3.0 Controls are prepared with recalcified human plasma. The Negative Control is nonreactive for anti-HCV, HBsAg and anti-HIV-1/HIV-2. The Positive Control is recalcified human plasma reactive for anti-HCV, and non reactive for HBsAg and anti-HIV-1/HIV-2.Axsym Probe Cleaning Solution 4 Bottles (110ml each) AxSYM Probe Cleaning Solution containing 2% Tetraethylammoniumhydroxide (TEAH).Solution 1(MUP) 4 Bottles (230ml each) Solution 1(MUP) containing 4-Methylumbelliferyl Phosphate,1.2mMSolutoin 3(Matrix Cell Wash) 4 Bottles (1000ml

可改用包裝上的完整型號或許可證字號查詢。