亞培”妙芮絲”C型肝炎病毒抗體檢驗試劑(第四代)

Murex Anti-HCV Version 4.0

衛署醫器輸字第011741號

本站收錄狀態已註銷

有效日期2022 / 08 / 12

醫療器材級數第三等級

這張許可證已註銷（2022/04/18，自請註銷），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: 酵素免疫分析法定性測試人體血清或血漿中之C型肝炎病毒抗體。
規格: 盒裝
主成分: 1. Antigen coated wells:One plate or five plates each made up of 96 microwells coated with purified HCV antigens.2. Sample diluent:One bottle of 20ml, or one bottle of 100ml of Buffer containing proteins of bovine and porcine origin. Contains 0.05% bronidox and 0.1% sodium azide as preservative.3. Negative control:One bottle containing normal human serum Diluted in a buffer containing protein of bovine origin. The Human serum has been tested and found to be non-reactive for Antibodies to HCV and to human immunodeficiency virus types 1 and 2 (HIV-1 and HIV-2) and also non-reactive for hepatitis B surface antigen (HBsAg). Contains 0.05% Bronidox preservative.4. Anti-HTLV positive control:One bottle of human serum containing Antibodies to HCV diluted in a buffer containing protein of bovine origin. The human serum was found to be non-reactive for HBsAg and antibodies to HIV-1 and HIV-2 and has been inactivated according to published procedures. Contains 0.05% Bronidox preservat

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