"鐳定" 濾泡刺激素放射免疫分析試劑

"RADIM" FSH MAIAclone

衛署醫器輸字第015115號

本站收錄狀態已註銷

有效日期2015 / 11 / 30

醫療器材級數第二等級

這張許可證已註銷（2018/05/28，許可證已逾有效期），以下僅供查閱歷史資料。申請商為 泰歷藥品儀器股份有限公司。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: 定量檢測人體血清、血漿、及尿液中濾泡刺激素FSH之含量。
規格: #13101: 150 Tubes, #13102: 300 Tubes, 以下空白。
主成分: 1. I-125 Anti-FSH Reagent (Red): 3 (or 6) vials, 5.4 ml per vial, containing fluorescein and iodine-125 labelled mouse monoclonal antibodies to FSH, <370 kBq per vial, in phosphate buffer containing normal sheep serum, bovine serum albumin (BSA), inert dye and sodium azide 0.2%, w/v.

2. FSH MAIAclone Calibrator 0 mIU/ml: 3.0 ml per vial, containing bovine serum with sodium azide, 0.2% w/v.

FSH MAIAclone Calibrators 0.5- 2- 10- 25- 75 and 150 mIU/ml: 1.0 ml per vial, precalibrated at 0.5- 2- 10- 25- 75 and 150 mIU/ml of FSH per ml (2nd IRP 78/549) in bovine serum with sodium azide, 0.2% w/v.

3. FSH MAIAclone Separation Reagent: 1 vial (33.0 ml), containing sheep antiserum to fluorescein covalently bound to magnetic particles in Tris buffer with BSA and sodium azide, 0.1% w/v.

4. MAIAclone Wash Buffer Concentrate: 1 vial (12.5 ml), containing Tris buffer and sodium azide, 0.8% w/v. Before use dilute the contents of the vial to a total volume of 100 ml with distilled or deionised wat

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