羅氏抗環瓜氨酸抗體檢驗試劑
Elecsys Anti-CCP

適應症
以免疫分析法半定量檢測人類血清和血漿中抗環瓜氨酸抗體(Anti-Cyclic Citrullinated Peptide Antibodies, Anti-CCP)。  
劑型
 
包裝
Elecsys Anti-CCP 05031656 190：100 tests, Elecsys PreciControl Anti-CCP 05031664 190：4 x 2.0 mL 
許可證字號
衛部藥製字第019981號 
註銷狀態
1 
註銷日期
2022-05-19  
註銷理由
888 
有效日期
2019-04-07  
發證日期
2009-04-07  
許可證種類
09 
中文品名
羅氏抗環瓜氨酸抗體檢驗試劑 
英文品名
Elecsys Anti-CCP 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
台灣羅氏醫療診斷設備股份有限公司  
申請商地址
台北市中山區民權東路3段2號10樓 
通關簽審文件編號
DHA00601998108 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 D-68305 MANNHEIM GERMANY DE
成份表
處方標示 成分名稱 含量 單位
1 M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative
1 R1 CCP~biotin (gray cap), 1 bottle, 9 mL:Biotinylated cyclic citrullinated peptides (synthetic) approx. 1.1 μg/mL, phosphate buffer 100 mmol/L, pH 5.0; preservative.
1 R2 Anti-human aggregated IgG~Ru(bpy)2+3 (black cap), 1 bottle, 10 mL:Ruthenylated monoclonal anti-human IgG antibody (mouse) 0.75 μg/mL; phosphate buffer 100 mmol/L, pH 6.0; preservative.
1 Cal1 Anti-CCP calibrator 1 (white cap), 2 bottles (lyophilized) for 1.0 mL each: Anti-CCP antibodies (human) approx. 20 U/mL in a human serum matrix.
1 Cal2 Anti-CCP calibrator 2 (black cap), 2 bottles (lyophilized) for 1.0 mL each: Anti-CCP antibodies (human) approx. 200 U/mL in a human serum matrix.
1 Calibrators: The exact lot-specific calibrator values are encoded in the barcoded labels of the test-specific reagent.
1 PC Anti-CCP1: 2 bottles, each for 2.0 mL of control serum\nAnti-CCP antibodies (human), approx. 30 U/mL in human serum.
1 PC Anti-CCP2: 2 bottles, each for 2.0 mL of control serum\nAnti-CCP antibodies (human), approx. 100 U/mL in human serum.