"奧素"第三代C型肝炎酵素聯結免疫試劑

ORTHO HCV 3.0 ELISA TEST SYSTEM WITH ENHANCED SAVE

衛署醫器輸字第011560號

本站收錄狀態已註銷

有效日期2016 / 10 / 09

醫療器材級數第三等級

這張許可證已註銷（2018/08/14，許可證已逾有效期），以下僅供查閱歷史資料。申請商為 台灣大昌華嘉股份有限公司。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: 酵素聯結免疫吸附分析法定性測試人類血清或血漿中的C型肝炎抗體，篩檢用。
主成分: 480 test kit:
5 Hepatitis C Virus (HCV) Encoded Antigen (Recombinant c22-3, c200 and NS5 Coated Microwell Plastes (96 wells each)-C22-3, c200, and NS5 derived from yeast.
1 Bottle Conjugate: Antibody to Human IgG (Murine Monoclonal) (125 ml)-anti-human IgG heavy chain (murine monoclonal) conjugated to horseradish peroxidase with protein with bovine protein stabilizers. Preservtive: 1% ProClin 300
1 Bottle Specimen Diluent (190mL)-phosphate-buffered saline with bovine protein stabilizers Preservative: 0.1% 2-chloroacetamide
1 vial OPD Tablets (30 tablets)-contains o-phenylenediamine. 2HCL
1 Bottle Substrate Buffer (190 mL)-citrate-phosphate buffer with 0.02% hydrogen peroxide Perservative: 0.1% 2-chloroacetamide
1 Vial Positive Control (Human)(1.2mL) Source: Inactivated human serum or plasma containing anti-HCV and nonreactive for hepatitis B surface antigen (HBsAg) and antibody to human immunodeficiency virus type 1 (HIV-1) and type 2(HIV-2) Preservative: 0.2% sodium azide and 0.9/EDTA 21 Plate Sealers, Disposable

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