凡立沙β2醣蛋白 I IgM抗體檢測試劑

Varelisa β2-Glycoprotein I IgM Antibodies

衛署醫器輸壹字第000425號

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有效日期2010 / 09 / 13

醫療器材級數第一等級

這張許可證已註銷（2013/01/21），以下僅供查閱歷史資料。申請商為 台灣法迪亞股份有限公司。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: 用來幫助用於人體血清或血中β2-醣蛋白類I IgM抗體的半定量以及性分析。
規格: 18896
主成分: Microplate Strips12 strips×8 wells, coated with human purified β-glycoprotein I antigen, foil pouch containsdesiccantCalibrators6 vials of b2-glycoprotein I IgM antibody calibrators at concentration of 0-4-8-20-50-100 U/ml in PBS containing BSA, 0.095% (w/v) sodium azide, detergent and human serum, 1.5 ml each Positive Control 1 vial (red cap) of buffer containing BSA, 0.095% (w/v) sodium azide, detergent and human serum, 1.5 ml Negative Control 1 vial (red cap) of buffer containing BSA, 0.095% (w/v) sodium azide, detergent and human serum, 1.5 ml Wash Buffer Concentrate 1 vial of 20x PBS concentrate containing 0.095% (w/v) sodium azide and detergent, 75 ml Sample Diluent 1 vial of PBS containing BSA, 0.095% (w/v) sodium azide and detergent, 100 ml (yellow colored) IgM HRP Conjugate 1 vial of anti-human IgM HRP (horse-radish peroxidase) conjugate, 20 ml (red colored) Substrate TMB 1 vial of TMB (3, 3’, 5, 5’ Tetramehylbenzidine), 20 ml. Stop Solution 1 vial of

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