亞培設計師心肌肌鈣蛋白-I檢驗試劑組

ABBOTT ARCHITECT STAT Troponin-I

衛署醫器輸字第013403號

本站收錄狀態已註銷

有效日期2010 / 10 / 31

醫療器材級數未載明

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 美商亞培股份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: 利用一化學冷光微粒酵素免疫分析法(CMIA)，可定量測試人類血清或血漿中的心肌肌鈣蛋白。
規格: #2K41G,#2K41J,#2K41H,#2K41L,#2K41M,#2K41N,#2K41A,#2K41B,#2K41C,#2K41D,#2K41E,#2K41F,#2K41,#2K41-01,#2K41-30,#2K41-25,#2K41-10, 以下空白。
主成分: ARCHITECT STAT Troponin-I Reagent Pack:
MICROPARTICLES: Anti-tropnin-I
(mouse, monoclonal) coated microparticles in TRIS buffer with protein
(bovine and goat) stabilizers
CONJUGATE: Anti-tropnin-I (mouse. Monoclonal) acridinium labeled conjugate in MES buffer with protein (bovine) stabilizer.
ASSAY DILUENT: Tropnin-I Assay Diluent contains protein (bovine and goat) stabilizers in phosphate buffer.
ARCHITECT STAT Troponin-I Calibrators:
Calibrator A contains human serum, nonreactive for HBsAg. HIV-1 Ag or HIV-1 NAT. anti-HCV. and anti-HIV-1/HIV-2.
Preservative: Sodium Azide. Calibrators B through F contain a recombinant human cardiac troponin IC complex in phosphate buffer with protein (bovine) stabilizer.
ARCHITECT STAT Troponin-I Controls:
contain a recombinant human cardiac troponin IC complex in BES buffer with protein (fish and human [donor units of which have been tested and found to be nonreactive for HBsAg. HIV-1 Ag or HIV-1 NAT. anti-HCV. and anti-HIV-1/HIV-2.])

可改用包裝上的完整型號或許可證字號查詢。