羅氏免疫分析抗促甲狀腺素受體抗體檢驗試劑
Elecsys Anti-TSHR

適應症
使用一個人類甲狀腺刺激的單株抗體，對人類血漿中抗促甲狀腺素受體的自體抗體進行體外定量檢測之免疫分析法。  
劑型
 
包裝
# 04388780：100 tests, # 05042666：2 x 2.0 ml 
許可證字號
衛部藥製字第019483號 
註銷狀態
1 
註銷日期
2015-04-09  
註銷理由
838 
有效日期
2013-11-11  
發證日期
2008-11-11  
許可證種類
09 
中文品名
羅氏免疫分析抗促甲狀腺素受體抗體檢驗試劑 
英文品名
Elecsys Anti-TSHR 
藥品類別
A 臨床化學及臨床毒理學 
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
DHA00601948305 
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 Reagent：\nReagent rackpack\nM Streptavidin-coated microparticles, 1 bottle, 6.5 mL: \nStreptavidin-coated microparticles 0.72 mg/mL; preservative. \nR1 Buffer solution 1 bottle, 7 mL: \nPhosphate buffer 20 mmol/L, pH 7.4; stabilizers; preservative.\nR2 Anti-TSHR~Ru(bpy)2+3,1 bottle, 7 mL:\nMonoclonal anti-TSHR antibody M22 (human) labeled with ruthenium complex approx. 0.3 mg/L; phosphate buffer 20 mmol/L, pH 7.4; stabilizers, preservative.\nCalibrators\nCal1 Anti-TSHR calibrator 1, 1 bottles (lyophilized) for 2.0 mL :\nAnti-TSHR antibody (human) approx. 1.0 IU/L in a human serum matrix.\nCal2 Anti-TSHR calibrator 2, 1 bottles (lyophilized) for 2.0 mL :\nAnti-TSHR antibody (human) approx. 25 IU/L in a human serum matrix.
1 Pretreatment rackpack\nPT1 Pretreatment buffer solution, 1 bottle, 4 mL:\nPhosphate buffer 20 mmol/L, pH 7.4; stabilizers; preservative.\nPT2 Empty bottle for pretreatment reagent (PTR)\nreconstituted with pretreatment buffer (PTB)\nPTR Pretreatment reagent, pTSHR-anti-pTSHR-Ab~biotin complex\n1 bottle for 4 mL of PTB:\nPhosphate buffer 40 mmol/L, pH 7.2; stabilizers.\nPTB Pretreatment buffer 1 bottle, 5 mL:\nReconstitution medium for PTR; phosphate buffer\n10 mmol/L, pH 7.2; stabilizer.
1 PreciControl：\nPC Thyro1: 1 bottle, for 2.0 mL of control serum\nAnti-TSHR antibody (human) approx. 4 IU/L in a human serum matrix.\nPC Thyro2: 1 bottle, for 2.0 mL of control serum\nAnti-TSHR antibody (human) approx. 16 IU/L in a human serum matrix.