拜奈克思退伍軍人肺炎尿液抗原酵素免疫分析試劑

Binax Legionella Urinary Antigen EIA

衛署醫器輸壹字第000765號

本站收錄狀態已註銷

有效日期2010 / 10 / 04

醫療器材級數第一等級

這張許可證已註銷（2012/11/06，許可證已逾有效期），以下僅供查閱歷史資料。申請商為 大陳生物科技股份有限公司。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: 定性檢驗人體尿液中L.pneumophila serogroup 1 antigen。
規格: 96 wells
主成分: Microtiter Wells- Each kit contains 96 Microtiter Wells, coated with purified rabbit anti-Legionella pneumophila serogroup 1 IgG.
Wash Concentrate- One (1) vial with 40mL of 0.1 M Phosphate Buffered Saline, detergent and preservative. Dilute the contents to 400 mL with distilled or deionized water for use.
Positive Control Urine- One (1) vial with 2 mL of human urine containing Legionella pneumophila serogroup 1 antigen and preservative.
Negative Control Urine- One (1) vial with 2 mL of normal human urine and preservative. Ready for use.
HRP Conjugate- One (1) vial with 15 mL of purified rabbit anti-Legionella pneumophila serogroup 1 IgG conjugated to horseradish peroxidase (HRP) in a Tris buffer with a protein stabilizer. Contains less than 0.02% thimerosal as a preservative.
Color Developer- One (1) vial with 25 mL of chromogenic substrate solution containing tetramethylbenzidine (TMB) and hydrogen peroxide.
Stop Solution- One (1) vial with 10 mL of 1N H2SO4.

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