羅氏血液氣體電解質分析儀 cobas b 221
Roche cobas b 221

適應症
Roche Blood Gas Omni S是一部模組分析儀，可以從全血、血清、血漿、醋酸和碳酸氫鹽包括透析液和QC物料中測量血液氣體、電解質、總血紅素、氧飽和度和血球容積比。  
劑型
 
包裝
Omni S2, S4, S6; S1 Rinse solution (1850 ml x 2 PCS); S2 Fluid pack (1950 ml x 1 PC); tHb Calibrator (5 Amp. x 2 ml); S3 Fluid pack A (1 PC); Deproteinizer (125 ml); W waste container, 2 PCS; Sensor GLU/LAC/UREA; Sensor GLU/LAC; Sensor GLU 
許可證字號
衛部藥製字第016116號 
註銷狀態
0 
註銷日期
 
註銷理由
 
有效日期
2026-03-08  
發證日期
2006-03-08  
許可證種類
09 
中文品名
羅氏血液氣體電解質分析儀 cobas b 221 
英文品名
Roche cobas b 221 
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
臺北市中山區民權東路3段2號10樓 
通關簽審文件編號
DHA00601611602 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
Roche Diagnostics International Ltd Forrenstrasse 2, 6343 Rotkreuz, Switzerland CH {"value":"P01","name":"Manufactured by"}
ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 D-68305 MANNHEIM, GERMANY DE {"value":"P02","name":"\u59d4\u8a17\u88fd\u9020\u8005"}
成份表
處方標示 成分名稱 含量 單位
1 S2 Fluid pack: Na-, K-, Ca-salts and organic amine buffer components, sodiumsulfite, sodiumhydrogendifluoride (<1%), sodiumhypochlorite (<1.5% active chlorine).\nCOMBITROL PLUS B Level 1-3: formulated using aqueous solution equilibrated with predetermined levels of oxygen, carbon dioxide and nitrogen with salts, organic and carbonate buffers.\nS3 Fluid pack A 1PC: D(+)-Glucose, L-Lactic acid sodium salt, Urea, Uric acid, Ammoniumchloride, Potassiumchloride.\nSOL. COMBITROL Level 1-3: formulated using aqueous solution equilibrated with predetermined levels of oxygen, carbon dioxide and nitrogen with salts, organic and carbonate buffers.\n
1 COMBITROL TS+ Level 1-3: formulated using aqueous solution equilibrated with predetermined levels of oxygen, carbon dioxide and nitrogen with salts, organic and carbonate buffers and polystyrene beads stabilized with a small amount of bovine serum albumin (<0.5%).\nSol. A: aqueous solution with wetting agent; Sol. B: electrolytes, carbonate, bicarbonate; Sol. C: electrolyte and basic buffer components; Sol. R: potassium chloride 1.2 mol/l; Sol. 2: ammonium hydrogen difluoride 100 mmol/l; Sol. 4: sodium sulphite 600 mmol/l; Sol. 6: sodiumhypochlorite <1% active chlorine neodisher Ma: 0.35%\n