〝西門子〞全自動尿液分析系統
Clinitek Atlas Automated Urine Chemistry System

適應症
Clinitek ATLAS 全自動尿液分析儀是全自動反射式光學分析儀，應用於臨床尿液檢查使用。  
劑型
 
包裝
Clinitek Atlas 10 Reagent Pak for Urine Chemistry (490 tests/Roll) 
許可證字號
衛部藥製字第015187號 
註銷狀態
0 
註銷日期
 
註銷理由
 
有效日期
2025-12-02  
發證日期
2005-12-02  
許可證種類
09 
中文品名
〝西門子〞全自動尿液分析系統 
英文品名
Clinitek Atlas Automated Urine Chemistry System 
藥品類別
A 臨床化學及臨床毒理學 
申請商名稱
西門子醫療設備股份有限公司  
申請商地址
臺北市南港區園區街3號2樓之2 
通關簽審文件編號
DHA00601518707 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
SIEMENS HEALTHCARE DIAGNOSTICS INC. 430 S. BEIGER STREET, MISHAWAKA, IN 46544, USA US
成份表
處方標示 成分名稱 含量 單位
1 Clinitek Atlas 10 Reagent Pak for Urine Chemistry：Protein: 0.3% tetrabromphenol blue; 97.3% buffer; 2.4% nonreactive ingredientsBlood: 6.8% diisopropylbenzene dihydroperoxide; 4.0% 3,3’,5,5’- tetramethylbenzidine; 48.0% buffer; 41.2% nonreactive ingredientsLeukocyte: 0.4% derivatized pyrrole amino acid ester, 0.2% diazonium salt; 40.9% buffer; 58.5% nonreactive ingredientsNitrite: 1.4% p-arsanilic acid; 1.3% 1,2,3,4-tetrahydro-benzo(h)- quinolin-3-ol; 10.8% buffer; 86.5% nonreactive ingredientsGlucose: 3.8% glucose oxidase (bacterial); 0.3% peroxidase (horseradish); 19.2% 4-aminoantipyrine; 11.7% 4-methylcatechol; 26.2% buffer; 38.8% nonreactive ingredientsKetone: 7.1% sodium nitroprusside; 92.9% bufferpH: 0.2% methyl red; 2.8% bromthymol blue; 97.0% nonreactive ingredientsBilirubin: 0.4% 2,4-dichloroaniline diazonium salt; 37.3% buffer; 62.3% nonreactive ingredientsUrobilinogen: 0.2% p-diethyaminobenzaldehyde; 99.8% nonreactive ingredients
1 Calibrator 1：0.20 % w/v potassium phosphate monobasic, 0.18% w/v sodium chloride, 0.10% w/v sodium acetate, 0.80% w/v urea, preservative
1 Calibrator 2：2.00 % w/v potassium phosphate monobasic, 1.80% w/v sodium chloride, 1.00% w/v sodium acetate, 8.00% w/v urea, preservative
1 Calibrator 3：0.50 % w/v potassium phosphate monobasic, 0.45% w/v sodium chloride, 0.25% w/v sodium acetate, 2.00% w/v urea, 2.00% w/v glucose, 0.50% w/v bovine albumin, preservative
1 Calibrator 4：0.01% w/v polymer beads, surfactant, 0.05% w/v sodium azide
1 Rinse Additive：3.5% w/v hexadecyltrimethylammonium hydrogen sulfate, 3.5% w/v magnesium chloride hexahydrate, surfactant