醣倍適 TM 雙重測試試劑
D-10 TM Dual Program

適應症
使用離子交換高效能液相色層分析儀(HPLC)來決定HbA1c、HbA2、HbF的百分比含量及偵測各種異常的血紅素。  
劑型
 
包裝
#220-0201：400 Test (HbA1c), 200 Test (HbA2/F/A1c) 
許可證字號
衛部藥製字第018698號 
註銷狀態
0 
註銷日期
 
註銷理由
 
有效日期
2027-12-07  
發證日期
2007-12-07  
許可證種類
09 
中文品名
醣倍適 TM 雙重測試試劑 
英文品名
D-10 TM Dual Program 
藥品類別
B 血液學及病理學裝置 
申請商名稱
美商伯瑞股份有限公司台灣分公司  
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
DHA00601869808 
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
1 220-0210： Elution Buffer 1. Two bottles containing 2000 mL of a Bis-Tris/Phosphate buffer, pH 6.0. Contains < 0.05% sodium azide as a preservative.\n220-0211：Elution Buffer 2. One bottle containing 1000 mL of a Bis-Tris/Phosphate buffer, pH 6.7. Contains < 0.05% sodium azide as a preservative.\n220-0112：Wash/Diluent Solution. One bottle containing 1600 mL of deionized water with < 0.05% sodium azide as a preservative.\n220-0128：HbA1c Calibrator/Diluent Set. One set consisting of three vials of Calibrator Level 1, three 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 deionized water with < 0.05% sodium azide as a preservative.
1 220-0218：HbA2/F/A1c Calibrator/Diluent Set. One set consisting of three vials of Calibrator Level 1, three 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 deionized water with < 0.05% sodium azide as a preservative.\n220-0212：Analytical Cartridge. One cation exchange cartridge, 4.0 mm ID x 30 mm.\n220-0148：Whole Blood Primer. Four vials of lyophilized human red blood cell hemolysate with gentamicin, tobramycin, and EDTA as preservatives. Reconstituted volume is 1.0 mL per vial.\n220-0215：Floppy Diskette with D-10 Dual Program parameters.\n220-0149：Sample Vials. 100 polypropylene vials with pierceable caps, 1.5 mL.\nThermal Paper. One roll.