拜爾斯達光學免疫法披衣菌測定試劑

BioStar CHLAMYDIA 0IA

衛署醫器輸壹字第001744號

本站收錄狀態已註銷

有效日期2010 / 11 / 04

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: 檢測子宮頸內棉棒檢體中的披衣菌抗原。
規格: #CHL30: 30 tests/box
主成分: Reagent 1A:
Extraction Reagent: pH 6.0 buffer solution containing dithioerythritol and a broad spectrum protease.
Reagent 1B:
Extraction Reagent: pH 13.0 buffer solution containing chenodeoxycholic acid.
Reagent 2:
neutralizer: pH 7.0 buffer solution containing guanidine-HCl preserved with 0.5% ProClin 300 Preservative.
Reagent 3:
Conjugae: pH 8.0 buffered protein solution containing anti (C. trachomatis) antibody (murine) conjugated to Horseradish peroxidase (HRP) and preserved with 0.5% ProClin 300 solution.
Reagent 4:
Wash Solution: pH 7.8 saline buffer preserved with 0.1% ProClin 300 preservative.
Substrate:
pH 5.5 aqueous solution of tetramethylbenzidine (TMB) and hydrogen peroxide.
Positive Control:
pH 7.0 protein solution containing inactivated C. trachomatis and preserved with 0.5% ProClin 300 preservative.
Test Devices:
Protein coated surface spotted with goat anti-moue IgG as a procedural control.

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