維特司生化產品直接醣化血色素試劑

醫療器材許可證 · 許可證字號：衛署醫器輸字第017911號

許可證字號

衛署醫器輸字第017911號

註銷狀態

已註銷

註銷日期

2024/04/12

註銷理由

許可證已逾有效期

有效日期

2022/02/12

發證日期

2007/02/12

許可證種類

09

醫療器材級數

2

通關簽審文件編號

DHA00601791103

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

效能

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。

醫器主類別一

B 血液學、病理學及基因學

醫器次類別一

B.7470 糖(基)化血紅素分析

主成分略述

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 Ing…展開

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. 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收合

醫器規格

#6802314: 300 tests#6801702: 4 x 2 mL#6801750, #6801751: 3 x 1 mL #6801873: 12 x 3 mL#6801874: 12 x 5 mL

限制項目

輸 入

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

申請商統一編號

70824858

製造商名稱

ORTHO-CLINICAL DIAGNOSTICS, INC

製造廠廠址

100 INDIGO CREEK DRIVE, ROCHESTER, NEW YORK 14626-5101, U.S.A.

製造廠國別

US

異動日期

2024/05/21

建立時間 2026-09-22 15:59:33 · 更新時間 2026-09-22 15:59:33