適應症
以酵素免疫分析法選擇人體血清中的C.difficle Toxin A及Toxin B的定量檢測。  
劑型
 
包裝
616096 
許可證字號
44000564 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2025-09-23  
發證日期
2005-09-23  
許可證種類
09 
中文品名
美利迪恩困難棒狀桿菌毒素A和B酵素連結免疫分析法檢測系統 (未滅菌) 
英文品名
Meridian Bioscience C. difficile Toxins A&B Test System (Non-Sterile) 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
碩景股份有限公司  
申請商地址
台北市信義區松德路74號8樓 
通關簽審文件編號
DHA04400056400 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
MERIDIAN BIOSCIENCE, INC 3471 RIVER HILLS DRIVE, CINCINNATI, OH 45244, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 1. 96 Antibody coated Microwells-Breakaway plastic wells coated with mouse monoclonal anti-toxin A antibody and polyclonal goat anti-toxin B antibody.2. Positive Control (2.6ml)-Inactivated toxin A and B in buffered protein solution containing gentamicin and thimerosal (0.02%) as a preservative.3. Sample Diluent/Negative Control (21.0ml)-Buffered protein solution containing gentamicin and thimerosal (0.02%) as preservative.4. 20X Wash Buffer (50ml)-Concentrated was buffer containing thimerosal (0.2%) as a preservative.5. Enzyme Conjugated (6.0ml)-Polyclonal goat anti-toxin A and anti-toxin B antibodies conjugated to horseradish peroxidase in buffered protein solution containing gentamicin and thimerosal (0.02%) as a preservative.6. Substrate (12.5ml)-Buffered solution containing urea peroxide and tetramethyl benzidine.7. Stop Solution (13.0ml)-1M Phosphoric acid. CAUTION: Avoid contact with skin. Flush with water if contact occurs.8. 96 Sample Transfer pipets9. 2 Microwell plate sealers