"日立" 化學冷光過敏原特異性 IgE 抗體診斷試劑

"HITACHI" CLA ALLERGEN SPECIFIC IGE ASSAY

衛署醫器輸字第010969號

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有效日期2009 / 12 / 21

醫療器材級數未載明

這張許可證已註銷（2012/10/29，許可證已逾有效期），以下僅供查閱歷史資料。申請商為 醫杏企業有限公司。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: 化學冷光分析法測試人體血清中過敏原特異性 IgE 抗體。
規格: 20 Tests／盒。
主成分: 1.Test Chambers 20 test chambers Specific allergens or allergen mixes covalently bound to cellulose thread2.Wash Buffer Concentrate Two bottles, 50ml Solution that when diluted contains 0.01M phosphate -buffered saline, 0.1% Tween 20, and 0.001% sodium azide as preservative3.IgE Antibody One bottle, 32ml Solution containing:Blue-colored solution containing Enzyme-labeled goat anti-human IgE, 0.01 M phosphate-buffered saline,pH 7.2, protein stabilizers, 0.1% Proclin as a preservative.4.Photoreagent A One bottle, 8ml Solution containing:14-30 mM 3-aminophthalhydrazide (luminol) 5.Photoreagent B One bottle, 8ml Solution containing: 0.05 M borate buffer, pH 9.46.Photoreagent C One bottle, 8ml Red-colored solution containing:0.0025 M ethyl orange7.Photoreagent D One bottle, 8ml Solution containing: 0.004 M hydrogen peroxide8.Test Chamber Rubber Plugs (black) 22plugs For top of Test Chambers9.Test Chamber Rubber Plugs (white)

可改用包裝上的完整型號或許可證字號查詢。