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GlucoSure II Blood Glucose Monitoring System

衛署醫器製字第001820號

本站收錄狀態已逾有效期

有效日期2010 / 11 / 07

醫療器材級數未載明

這張許可證的有效日期已過，請向申請商確認是否已展延。申請商為 五鼎生物技術股份有限公司。以下整理許可證、規格與製造廠資料，供核對產品身分使用。

許可證資料依公開資料欄位整理

效能: 體外檢驗用全血血糖定量檢測系統。
規格: KIT include: meter, 10 test strips, 10 lancets, adjustable lancing device, code card,R-checker, user's guide, test strip insert, log book, carrying case.100's test strips, 2*25;s test strips, 50's test strips, control solution has L1 & L2 with 2.5ml.
主成分: Each test strip contains per cm2 of reaction zone approximately:
Glucose oxidase 30 I.U., electron shuttle 1.5 mg, enzyme protector 0.13 mg, non reactive ingredients 2.5ml
Control solution has D-glucose as the reactive ingredient in approximate concentration of:
Level 1 is 0.06%, Level 2 is 0.15%.

可改用包裝上的完整型號或許可證字號查詢。