"恩奈格斯特" 帶狀泡疹病毒 IgM抗體檢驗試劑組

"Enzygnost" Enzygnost Anti-VZV/IgM

衛署醫器輸字第013315號

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有效日期2020 / 10 / 27

醫療器材級數第二等級

這張許可證已註銷（2021/03/04，未展延而逾期者），以下僅供查閱歷史資料。申請商為 西門子醫療設備股份有限公司。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: 定性檢測和定量測定人類血清和血漿中帶狀泡疹病毒特異性IgM抗體的酵素免疫分析法。
規格: #|OWL 15: 2×48 Test/kit
主成分: Enzygnost* Anti-VZV/igM Test Plate: microtitration plate coated with inactivated VZV-antigens The left row of a strip contains antigen from VZV infected human fibroblasts and the right row contains antigen from uninfected cells (=control antigen).
Anti-Human-IgM/POD Conjugate: Goat antibodies to human IgM conjugated with peroxidase in 0.05 mo/L Tris/HCl Buffer solution, pH 7.2, with polygeline 0.5%.
Conjugate Buffer Microbiol: 37 mg EDTA in one liter of 0.01 mol/L phosphate buffer solution, pH 7.2, with Tetronic, approximately 2%, BSA approximately 1%.
Anti-VZV Reference P/P: Human serum with IgG-antibodies to VZV-antigens in conjunction with rheumatoid factors (RF) in Tris buffer solution (20 mmol/L), pH 7.4, with HUmanalbin (5%), approximately 60%.
Anti-VZV Reference P/N: Human serum with IgG-antibodies to VZV-antigens in Tris buffer solution (20 mmol/L), pH 7.4, with Humanalbin (5%), approximately 60%.
Sample Buffer POD 0.3 mol/L Tris/HCl buffer solution, pH 8.0-8.2, with Tween 20 approximately 0.

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