適應症
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。 
劑型
 
包裝
 
許可證字號
衛部藥製字第011560號 
註銷狀態
註銷日期
2018-08-14  
註銷理由
838 
有效日期
2016-10-09  
發證日期
2005-06-29  
許可證種類
09 
中文品名
"奧素"第三代C型肝炎酵素聯結免疫試劑 
英文品名
ORTHO HCV 3.0 ELISA TEST SYSTEM WITH ENHANCED SAVE 
藥品類別
 
申請商地址
臺北市內湖區堤頂大道2段407巷20弄1、3、5、7號10樓,及22、24、26號10樓及22號10樓之1 
通關簽審文件編號
DHA00601156009 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ORTHO-CLINICAL DIAGNOSTICS, INC. 1001 U.S. HIGHWAY 202, RARITAN, NEW JERSEY 08869 U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 480 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 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