亞培”愛可信”A型肝炎IgM抗體檢驗試劑(第二代)

AxSYM HAVAB-M 2.0

衛署醫器輸字第011750號

本站收錄狀態已註銷

有效日期2017 / 02 / 20

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體血清或血漿中A型肝炎IgM抗體
規格: 盒裝
主成分: Each AxSYM HAVAB-M 2.0 Reagent Pack (100tests) contains: 1 Bottle (10.5ml) Antibody to Human IgM (goat) Coated microparticles in TRIS buffer with protein stabilizers. Minimum concentration: 0.02% solids. Preservative:0.1% sodium azide. 1 Bottle (12.4ml) Antibody to Hepatitis A virus (Mouse, Monoclonal):Alkaline Phosphate Conjugate in TRIS buffer with protein stabilizers. Minimum concentration: 0.9u g/ml. Preservatvies: 0.2% Sodium azide and antimicrobial agents. 1 Bottle (9.6ml) Hepatitis A virus (Human) in phosphate buffer with protein stabilizers. Titer≧3,000. Preservative:0.1% sodium azide. The virus has been inactivated with formaldehyde, 1 Bottle(50.2ml) Specimen diluent containing sodium chloride in TRIS buffer. Preservatives:0.1% sodium azide and antimicrobial agents. 1 Bottle(1.8ml) AxSYM HAVAB-M 2.0 Index Calibrator. Recalcified human plasma reactive for IgM anti-HAV, nonreactive for HBsAg, HIV-1 Ag, anti-HCV, and anti-HIV-1/HIV/2, Titer=1.1. Preservative: 0.1% S

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