適應症
利用離子交換高效液相層析(HPLC)測定人類全血中醣化血色素A1c的比例。  
劑型
 
包裝
#270-2415: 2000 tests#270-2416: 2000 tests 
許可證字號
衛部藥製字第016467號 
註銷狀態
註銷日期
2018-06-28  
註銷理由
888 
有效日期
2016-04-25  
發證日期
2006-04-25  
許可證種類
09 
中文品名
威力安TM II T醣化血紅素分析測試 
英文品名
VARIANTTM II TURBO Hemoglobin A1c Program 
藥品類別
B 血液學及病理學裝置 
申請商地址
台北市松山區南京東路4段126號14樓 
通關簽審文件編號
DHA00601646705 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DRIVE, HERCULES, CALIFORNIA 94547, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 270-2401: Elution Buffer A\nThree bottles containing 2500 ml of a Bis-Tris/Phosphate buffer, \npH 6.0. Contains < 0.05% sodium azide as a preservative.\n270-2402: Elution Buffer B \nOne bottle containing 1500 ml of a Bis-Tris/Phosphate buffer, \npH 6.7. Contains < 0.05% sodium azide as a preservative.\n270-2410: Cartridge Set\nOnc cation exchange (2000 test) analytical Cartridge (4.0mm ID x 34.2mm), and five cation exchange (400 tests each) Guard Cartridges (4.6 mm ID x 15.4 mm). Store cartridges at 2-8℃.\n270-2409; CD-ROM with VARIANT II TURBO Hemoglobin A1c program parameters.\n270-2404: Calibrator/Diluent Set.\nOne set consisting of three vials of calibrator level 1, three vials of Calibrator 2, and one bottle of Calibrator Diluent. The calibrator vials contain lypholized human red blood cell hemolysate with gentamicin, tobramycin, and EDTA as preservatives,. Reconstituted volume is 7ml per vial. Calibrator Diluent contains 100 ml of deionized water with < 0.05% sodium azide as a preservative.\n270-2413: W