拜爾斯達光學免疫法呼吸道融合病毒測定試劑

BioStar RSV OIA

衛署醫器輸壹字第001971號

本站收錄狀態已註銷

有效日期2010 / 11 / 16

醫療器材級數第一等級

這張許可證已註銷（2012/11/19，許可證已逾有效期），以下僅供查閱歷史資料。申請商為 瑞博企業有限公司。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: 偵測鼻腔沖洗液與鼻咽拭子檢體中的呼吸道融合病毒抗體(核蛋白與融合蛋白)。
規格: RSV30: 30 tests/box.
主成分: Sample Diluent:
0.85% NaCl
Reagent 1:
Specimen Extraction Reagent: pH 7.0 buffer solution containing surfactant and reducing agent.
Reagent 2:
Conjugate: pH 7.3 buffer solution containing surfactant, stabikizing proteins, 0.5% ProClin 300 solution, and two anti-Respiratory syncytial virus monoclonal antibodies (mouse) conjugated to Horseradish Peroxidase (HRP).
One of the two anti-RSV antibodies targets the nucleoprotein and the other targets the fusion protein. Contains 2.96% Gelatin Hydrolysate which is considered an irritant.
Wash:
pH 7.5 phosphate buffer containing surfactant.
Substrate:
pH 5.5 aqueous solution of tetramethylbenzidine (TMB) and hydrogen peroxide.
Positive Control:
pH 7.5 buffered protein solution (fetal calf serum) containing inactivated respiratory syncytial virus.
Negative Control:
pH 7.5 buffered protein solution (fetal calf serum).
Test Devices:
Surface coated with polyclonal anti-respiratory syncytial virus abtibody (goat) spotted with formalin inactivated respiratory

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