亞培愛可信B型肝炎e抗原第二代檢驗試劑

Abbott AxSYM HBe 2.0

衛署醫器輸字第011754號

本站收錄狀態已註銷

有效日期2016 / 04 / 24

醫療器材級數第三等級

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定性測試人體血清或血漿中B型肝炎e抗原
規格: 100 次測試/盒
主成分: AxSYM HBe 2.0 Reagent Pack1. 1 Bottle(6.9ml) Antibody to Hepatitis B e Antigen (Mouse, Monoclonal) Coated microparticles in TRIS buffer with protein stabilizers. Minimum concentration: 0.005% solids. Preservative: Sodium azide.2. 1 Bottle(10.3ml) Antibody to Hepatitis B e Antigen (Mouse, Monoclonal):Alkaline Phosphate Conjugate in HRIS buffer with protein stabilizers. Minimum concentration: 0.1ug/ml. Preservatives: Sodium azide and antimicobial agents.3. 1 Bottle(19.2ml) Wetting solution prepared TRIS buffer with protein stabilizers. Preservative: Antimicrobial agents.4. 1 Bottle(50.2ml) Specimen diluent containing sodium chloride in TRIS buffer. Preservatives: Sodium azide and antimicrobial agents.1 Bottle(4ml) AxSYM HBe 2.0 Index Calibrator (concentration:0.280PEI U/ml) containing recombinant DNA derived HbeAg in TRIS buffer with protein stabilizers. Preservative: Sodium azide.AxSYM HBe 2.0 Controls1 Bottle (9.0ml) of AsSYM HBe 2.0 Negative control is prepared in TRIS buffer with protein staAxSYM HBe 2.0 Re

可改用包裝上的完整型號或許可證字號查詢。