適應症
使用離子交換高效能液相層析(HPLC)的方法偵測人類全血中血色素A1c的百分比。  
劑型
 
包裝
# 270-2101NU:1000 Test 
許可證字號
衛部藥製字第018719號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2028-01-08  
發證日期
2008-01-08  
許可證種類
09 
中文品名
威力安 TM II 醣化血色素分析試劑 
英文品名
VARIANT TM II 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
DHA00601871903 
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 Quantity Description\n270-0350** 2 each\nWhole Blood Primer. Each vial contains lyophilized human red blood cell hemolysate with gentamicin, tobramycin, and EDTA as preservatives. Reconstituted volume is 1.0 mL per vial.\n270-2110NU** 3 each \nElution Buffer A. Each bottle contains 2500 mL of a Bis-Tris/Phosphate buffer, pH 6.0. Contains < 0.05% sodium azide as a preservative.\n270-2111NU** 1 each\nElution Buffer B. Each bottle contains 2500 mL of a Bis-Tris/Phosphate buffer, pH 6.7. Contains < 0.05% sodium azide as a preservative.
1 270-2112NU** 3 each \nWash/Diluent Solution. Each bottle contains 2500 mL of deionized water with < 0.05% sodium azide as a preservative.\n270-2113NU** 1 each\nAnalytical Cartridge. Cation exchange cartridge (1000 tests), 4.6 mm ID x 27.5 mm. Two prefilter elements (500 tests each) are included with the cartridge.\n270-2114NU** 1 each\nCD-ROM with VARIANT II Hemoglobin A1c program parameters.
1 270-2115NU** 1 each\nCalibrator/Diluent Set. One set consisting of two vials of Calibrator Level 1, two vials of Calibrator Level 2, and one bottle of Calibrator Diluent. The calibrator vials contain lyophilized human red blood cell hemolysate with gentamicin, tobramycin, and EDTA as preservatives. Reconstituted volume is 7 mL per vial. Calibrator Diluent contains 100 mL of deionzed water with < 0.05% sodium azide as a preservative.\n270-2149 1 each \nSample Vials. 100 polypropylene vials with pierceable caps, 1.5 mL.