- 適應症
- 供糖尿病患者進行血糖的自我監測，或由醫護專業人員代為測試，以檢測全血中的葡萄糖濃度。
- 劑型
- 包裝
- Each contains：1.CONTOUR TS Blood Glucose Meter, 2.CONTUOR TS User Guide, 3.CONTOUR TS Quick Reference Guide, 4.CONTUOR TS Quick Start Guide, 5.Ascensia MICROLET Adjustable Lancing Device with 5 lancets, 6.Carrying Case, 7.Contour TS Blood Glucose Test Strips-1840, 50 Strips (2 x 25 strips)-1841, 25 strips (1 x 25 strips)
- 許可證字號
- 衛部藥製字第019943號
- 註銷狀態
- 1
- 註銷日期
- 2017-12-28
- 註銷理由
- 841
- 有效日期
- 2019-02-10
- 發證日期
- 2009-02-10
- 許可證種類
- 09
- 中文品名
- “拜耳”拜安康血糖監測系統
- 英文品名
- “BAYER”CONTOUR TS Blood Glucose Monitoring System
- 藥品類別
- A 臨床化學及臨床毒理學
- 申請商名稱
- 臺灣拜耳股份有限公司
- 申請商地址
- 臺北市信義區信義路5段7號53樓
- 通關簽審文件編號
- DHA00601994300
- 資料更新時間
| 名稱 | 廠址 | 公司地址 | 國別 | 製程 |
|---|---|---|---|---|
| Manufactured by Panasonic Healthcare Co., Ltd. In Vitro Diagnostics Business Unit, Wakimachi Plant for Bayer Healthcare LLC | Manufactured by 110 Oaza-Inoshiri-aza-Nishiueno,Wakima- chi, Mima, Tokushima, 779-3603 Japan for430 S. Beiger Street, Mishawaka, IN 46544 U.S.A.） | JP | ||
| MANUFACTURED BY HTL-STREFA S.A. FOR BAYER HEALTHCARE LLC DIABETES CARE | MANUFACTURED BY ADAMOWEK 7, 95-035 OZORKOW, POLAND FOR 430 S. BEIGER ST, MISHAWAKA, IN 46544 USA | PL | ||
| MANUFACTURED BY KIMBALL ELECTRONICS FOR BAYER HEALTH CARE LLC, DIABETES CARE | MANUFACTURED BY 49/45 MOO 5, LAEMCHABANG INDUSTRIAL ESTATE, SUKHUMVIT ROAD, THUNGSUKLA, SIRACHA, CHONBURI 20230, THAILAND FOR 430S. BEIGER STREET, MISHAWAKA, IN 46544 USA | TH |
| 處方標示 | 成分名稱 | 含量 | 單位 |
|---|---|---|---|
| 1 | Test strips reagents：\nFAD glucose dehydrogenase (Aspergillus sp., 2.0 U/test strip) 6%W/W\nPotassium ferricyanide 56%W/W\nNon-reactive ingredients 38%W/W |