貝克曼庫爾特亞瑟斯高精確度心肌旋轉蛋白I 試劑組

BECKMAN COULTER Access AccuTnI Reagent

衛署醫器輸字第012263號

本站收錄狀態已註銷

有效日期2015 / 09 / 08

醫療器材級數第二等級

這張許可證已註銷（2018/08/09，未展延而逾期者），以下僅供查閱歷史資料。申請商為 美商貝克曼庫爾特有限公司台灣分公司。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: 定量偵測人類血清及血漿中心肌旋轉蛋白I的量，以幫助判斷心肌梗塞或心臟方面的疾病。
規格: 試劑#33340: 2×50Tests/Kit校正液#33345: 6×1 mL品管液#33349: 6×2.5mL，每個濃度各2瓶
主成分: Access AccuTnI ReagentR1a: Paramagnetic particles coated with mouse monoclonal anti-human cardiac tropnin I (cTnI) suspended in TRIS buffered saline, with surfactant, bovine serum albumin (BSA) matrix, <0.1% sodium azide, and 0.1% ProClin 300. R1b: 0.1 N NaOHR1c: Mouse monoclonal anti-human cTnI alkaline phosphatase conjugate diluted in ACES buffered saline, with surfactant, BSA matrix, protein (bovine, goat, mouse), <0.1% sodium azide, and 0.25% ProClin 300. Access AccuTnI CalibratorsS0: Buffered bovine serum albumin (BSA) matrix with surfactant <0.1% sodium azide, and 0.1% ProClin 300.S1, S2, S3, S4, S5: Recombinant troponin complex at cTnI levels of approximately 0.3, 1.2, 5.0, 25 and 100 mg/mL (μg/L) in buffered BSA matrix with surfactant, <0.1% sodium azide, and 0.1% ProClin 300.Access AccuTnI QCQC1: Recombinant troponin complex at a cTnI level of approximately 0.5 ng/mL (μg/L) in buffered bovine serum albumin (BSA) matrix with surfactant, <0.1% sodium azide, 0.1% ProClin 300.QC2:

可改用包裝上的完整型號或許可證字號查詢。