“亞培”艾斯特床旁血液監護儀
“Abbott” i-STAT Alinity Instrument

適應症
變更效能(調整文字敘述)為：本產品需搭配i-STAT晶片卡匣，用於定量檢測動脈、靜脈及微血管全血中各種分析物。  
劑型
 
包裝
AN-500，以下空白。 醫療器材規格與標籤、說明書或包裝變更為：詳如醫療器材標籤、說明書或包裝核定本(原108年4月15日醫療器材仿單標籤核定本回收作廢)。以下空白 
許可證字號
56032373 
註銷狀態
0 
註銷日期
 
註銷理由
 
有效日期
2029-03-14  
發證日期
2019-03-14  
許可證種類
09 
中文品名
“亞培”艾斯特床旁血液監護儀 
英文品名
“Abbott” i-STAT Alinity Instrument 
藥品類別
A 臨床化學及臨床毒理學 
申請商名稱
美商亞培股份有限公司台灣分公司  
申請商地址
台北市中山區民生東路三段49號5樓、6樓及51號6樓 
通關簽審文件編號
DHA05603237307 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ABBOTT POINT OF CARE INC. 400 COLLEGE ROAD EAST, PRINCETON, NJ 08540, USA US {"value":"P01","name":"Manufactured by"}, {"value":"P01","name":"Manufactured by"}, {"value":"P01","name":"Manufactured by"}, {"value":"P01","name":"Manufactured by"}, {"value":"P01","name":"Manufactured by"}, {"value":"P01","name":"Manufactured by"}, {"value":"P01","name":"Manufactured by"}, {"value":"P01","name":"Manufactured by"}, {"value":"P01","name":"Manufactured by"}, {"value":"P01","name":"Manufactured by"}, {"value":"P01","name":"Manufactured by"}, {"value":"P01","name":"Manufactured by"}, {"value":"P01","name":"Manufactured by"}
Abbott Point of Care Inc. 100 and 200 Abbott Park Rd, Abbott Park, IL 60064, USA US {"value":"P02","name":"\u59d4\u8a17\u88fd\u9020\u8005"}