美堅希堤亞斥消靈試劑組

MGC CEDIA Sirolimus

衛署醫器輸字第016853號

本站收錄狀態已註銷

有效日期2011 / 06 / 26

醫療器材級數第二等級

這張許可證已註銷（2014/06/12，許可證已逾有效期），以下僅供查閱歷史資料。申請商為 杏全實業股份有限公司。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: 希堤亞斥消靈試劑是一種使用自動臨床化學分析儀，以定量分析測定人類全血中斥消靈含量的體外診斷醫學方法。
規格: #100130#100132#100256#100257#100258
主成分: REAGENT-
1 E A Reconstitution Buffer: Contains TES [N-tris (hydroxylmethyl) methyl-2-aminoethanesulfonic acid] buffer, 0.60 μg/mL mouse monoclonal anti-sirolimus antibodies, stabilizer and preservative,
(1 x 26 mL).
1a E A Reagent: Contains 0.118 g/L Enzyme acceptor (microbial), buffer salts, and preservative, (1 x 26 mL).
2. E D Reconstitution Buffer: Contains MES (2-(N-morpholino) ethanesulfonic acid buffer), detergent, and preservative, (1 x 11 mL).
2a E D Reagent: Contains: 107μg /L Enzyme donor (microbial) conjugated to sirolimus, 2.73 g/L chlorophenol red-β-D-galactopyranoside, stabilizer, and preservative, (1 x 11 mL).
3 Extraction Reagent: Contains 300 mM ZnSO4, (1 x 50 mL).

Calibrators-Contains targeted concentrations of sirolimus:
Low Calibrator 0 ng/mL
High Calibrator 30 ng/mL

Controls-The CEDIA Sirolimus Controls are prepared from human whole blood, with pure chemicals and stabilizers. The controls are provided in lyophilized form and contains only Sirolimus. The Calibrator/Co

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