維特司生化產品直接醣化血色素試劑
Vitros Chemistry Products d % A1c Reagent Kit

適應症
定量測定人體血液中的血紅素與醣化血色素濃度以計算出醣化血色素的百分比。  
劑型
 
包裝
#6802314: 300 tests#6801702: 4 x 2 mL#6801750, #6801751: 3 x 1 mL #6801873: 12 x 3 mL#6801874: 12 x 5 mL 
許可證字號
衛部藥製字第017911號 
註銷狀態
1 
註銷日期
2024-04-12  
註銷理由
838 
有效日期
2022-02-12  
發證日期
2007-02-12  
許可證種類
09 
中文品名
維特司生化產品直接醣化血色素試劑 
英文品名
Vitros Chemistry Products d % A1c Reagent Kit 
藥品類別
B 血液學及病理學裝置 
申請商名稱
台灣大昌華嘉股份有限公司  
申請商地址
臺北市內湖區堤頂大道2段407巷20弄1、3、5、7號10樓，及22、24、26號10樓及22號10樓之1 
通關簽審文件編號
DHA00601791103 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ORTHO-CLINICAL DIAGNOSTICS, INC. 1000 LEE ROAD, ROCHESTER, NEW YORK, 14606, U.S.A. US
ORTHO-CLINICAL DIAGNOSTICS, INC 100 INDIGO CREEK DRIVE, ROCHESTER, NEW YORK 14626-5101, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 Vitros Chemistry Products d%A1c Reagent Kit (#6802314) containing:\n Reactive Ingredients- HbA1c\n HbA1c Reagent 1 (R1): HbA1c antibody (ovine serum)≧0.5 mg/mL\n HbA1c Reagent 2 (R2): HbA1c Polyhapten ≧8μg/mL\n Other Ingredients-HbAlc\n HbA1c Reagent 1 (R1): Buffer, stabilizers, and preservatives\n HbA1c Reagent 2 (R2): Buffer, stabilizers, and preservatives\n Reactive Ingredients-Hb\n Hb Reagent 1 (R1): Tetradecyltrimethylammonium bromide (TTAB)<1% (w/v)\n Hb Reagent 2 (R2): None\n Other Ingredients-Hb\n Hb Reagent 2 (R2): Buffer, stabilizers, and preservatives\n Vitros Chemistry Products Calibrator Kit 18 (#6801702) are prepared from a hemolysate derived from human and ovine blood to which surfactants and preservatives have been added.
1 VITROS Chemistry Products %A1c Performance Verifiers (#6801750, #6801751) are \nPrepared from a hemolysate derived from human and ovine blood to which surfactants \nand preservatives have been added.\nVitros Chemistry Products FS Calibrator 1 (#6801873) is prepared from sodium \nchloride (154 mM) and processed water.\nVITROS Chemistry Products FS Reconstitution Diluent (#6801874) is prepared from processed water.\n