易醣儀醣化血紅素測試系統
In2it TM A1c Point of Care Test

適應症
易醣儀醣化血紅素測試系統是用來檢驗從指尖、或是經由肝素、氟化物、EDTA (乙烯二胺四乙酸) 等抗凝血劑所取得的靜脈血液中醣化血紅素的數值。  
劑型
 
包裝
281-0000EX in2it (I) Analyzer, 281-0001EX in2it (I) A1c Test Cartridges, 281-0002 in2it System Check Cartridge, 281-0003 in2it A1c Quality Controls, 281-0004 in2it Printer, 281-0006 in2it Keypad, 281-0007 in2it Barcode Reader, 281-0008 in2it System Software 
許可證字號
衛部藥製字第019080號 
註銷狀態
1 
註銷日期
2019-12-13  
註銷理由
838 
有效日期
2018-06-06  
發證日期
2008-06-06  
許可證種類
09 
中文品名
易醣儀醣化血紅素測試系統 
英文品名
In2it TM A1c Point of Care Test 
藥品類別
B 血液學及病理學裝置 
申請商名稱
美商伯瑞股份有限公司台灣分公司  
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
DHA00601908009 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
BIO-RAD LABORATORIES DEESIDE UNIT 37, DRIVE B, FIRST AVENUE, DEESIDE INDUSTRIAL PARK, DEESIDE, FLINTSHIRE, CH5 2NU, UK GB
成份表
處方標示 成分名稱 含量 單位
1 281-0000EX contains the following: 1 each in2it Analyzer, 1 each Power Supply and Power Cord, 1 each in2it (I) Analyzer Operation Manual, 1 each Multiple-Language CD of the product manuals/package inserts, 1 each Quick Reference Guide, 1 each MiniPet Pipette, 50 each Pipette Tips, 50 each Sample Trays (for venous or control samples), 1 each Cartridge Workstand.
1 281-0001EX contains the following: 10 each in2it (I) A1c Test Cartridge. Each test cartridge contains the following reagents: sample reagent: boronate affinity resin, surfactant, sodium azide (0.1%), and buffer. Wash solution: buffer, surfactant, and sodium azide (0.1%). Elution buffer: buffer, surfactant, and sodium azide (0.1%). 11 each Blood Key. a capillary device in the form of a key. 1 each Instruction Manual.
1 281-0003 contains the following: A1c Control 1: contains lyophilized human whole blood with gentamicin, tobramycin, and EDTA as preservatives. White cap. A1c Control 2: contains lyophilized human whole blood with gentamicin, tobramycin, and EDTA as preservatives. Black cap. A1c Control Diluent: contains deionized water. Sample Trays 5 each. PackageInsert 1 each.