適應症
威力安 II 是全自動的HPLC 系統,可以用來檢測血紅素A2和F的百分比,以及提供判斷不正常的血紅素。  
劑型
 
包裝
270-2103:250 Tests, 270-2154:500 Tests 
許可證字號
衛部藥製字第018944號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2028-01-28  
發證日期
2008-01-28  
許可證種類
09 
中文品名
威力安 II 乙型地中海貧血檢驗試劑 
英文品名
VARIANT TM II β Thalassemia Short 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
DHA00601894400 
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 DR. HERCULES, CA 94547, USA US
成份表
處方標示 成分名稱 含量 單位
1 2702154/270-2103: 500 tests/250 tests\n270-0004: Elution Buffer 1. Three/Two reservoirs containing 1900 mL of a sodium phosphate buffer; contains less than 0.05% sodium azide as a preservative.\n270-0005: Elution Buffer 2. Two/One reservoirs containing 1800 mL of a sodium phosphate buffer; contains less than 0.05% sodium azide as a preservative.\n270-0011: Whole Blood Primer. Three boxes each containing ten vials of lyophilized human red blood cell hemolysate with gentamicin, tobramycin and EDTA as preservatives. Reconstituted volume is 1.0 mL per vial.\n270-0083: HbA2/F Calibrator/Diluent Set. One box containing six vials of lyophilized human red blood cell hemolysate containing gentamicin, tobramycin and EDTA as a preservative. The reconstituted volume is 10 mL per vial. The Diluent bottle contains 100 mL of deionized water with less than 0.05% sodium azide as a preservative.
1 270-0182: Analytical Cartridge. Two/One cation exchange analytical cartridges, 4.6 mm I.D. by 30 mm. Capable of performing up to 250 injections each.\n270-2149: Sample Vials. 100 polypropylene sample vials, 1.5 mL with pierceable caps.\n270-2164: Wash/Diluent. Two/One reservoirs containing 1800 mL of deionized water. Contains less than 0.05% sodium azide as a preservative.\n270-2165: CD-ROM. One CD with VARIANT II β-thalassemia Program parameters.