適應症
本拋棄式卡匣為寶石比米爾3000系統(GEM Premier 3000 System)之主要配件、提供作為快速全血檢驗分析之用,可提供有關血液氣體、血容比等測量及計算參數。  
劑型
 
包裝
00024307504 GEM Premier 3000 - BG/HCT - 75 Tests 00024315004 GEM Premier 3000 - BG/HCT - 150 Tests 00024330004 GEM Premier 3000 - BG/HCT - 300 Tests 00024345004 GEM Premier 3000 - BG/HCT - 450 Tests 00024403584 GEM Premier 3000 iQM - BG/HGT - 35 Tests00024307584 GEM Premier 3000 iQM - BG/HGT - 75 Tests 00024407584 GEM Premier 3000 iQM - BG/HCT - 75 Tests (4 Week Cartridge) 00024315084 GEM Premier 3000 iQM - BG/HCT - 150 Tests 00024330084 GEM Premier 3000 iQM - BG/HCT - 300 Tests 00024345084 GEM Premier 3000 iQM - BG/HCT - 450 Tests 00024360084 GEM Premier 3000 iQM - BG/HCT - 600 Tests 
許可證字號
衛部藥製字第020973號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2025-04-15  
發證日期
2010-04-15  
許可證種類
09 
中文品名
“儀器實驗室”寶石比米爾3000專用卡匣(血液氣體/血容比) 
英文品名
“Instrumentation Laboratory” GEM Premier 3000 PAK(BG/HCT) 
藥品類別
A 臨床化學及臨床毒理學 
申請商名稱
台灣沃芬有限公司  
申請商地址
臺北市內湖區堤頂大道2段501號4樓 
通關簽審文件編號
DHA00602097309 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
INSTRUMENTATION LABORATORY CO. 180 HARTWELL RD. BEDFORD, MA 01730-2443 USA US
成份表
處方標示 成分名稱 含量 單位
1 \nThe internal waste bag, which collects used blood and solutions throughout cartridge life, keeps biohazard to a minimum.\nThe cartridge contains solutions with the following approximate concentrations:\nReference Solution A pH 6.9 organic buffer; pCO2 = 65 mmHg,\npO2 = 0 mmHg, Na+ = 155 mmol/L\nK+ = 2 mmol/L, Ca++ = 0.2 mmol/L,\nsurfactant and inert preservative\nReference Solution B pH 7.40 organic buffer; pCO2 = 35\nmmHg, pO2 = 190 mmHg, Na+ = 135mmol/L, \nK+ = 6 mmol/L, Ca++ = 2.0mmol/L, \nsurfactant and inert preservative buffer\nReference Solution C For low level oxygen calibration, conditioning the glucose and lactate sensors, and cleaning the sensor chamber; contains aqueous solution of Na+ and K+ salts, surfactant and inert preservative, organic buffer, and pCO2\nReference Solution D KNO3 = 1000 mM/L, AgNO3= 1 mM/L, and surfactant