常盈卵泡刺激激素檢驗試劑

DSL FSH IRMA

衛署醫器輸字第015861號

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有效日期2011 / 01 / 10

醫療器材級數未載明

這張許可證已註銷（2012/11/26，許可證已逾有效期），以下僅供查閱歷史資料。申請商為 常盈實業股份有限公司。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: 利用放射性免疫定量方法檢測血清中卵泡刺激激素荷爾蒙。
規格: DSL-4700 100 tubes、DSL-4700-5 500 tubes
主成分: FSH Standards:One vial, 2.0 mL, labeled A, containing 0 mIU/mL and six vials, 1.0 mL each, labeled B-G, containing concentrations of approximately 1.5, 4.5, 15.0, 45.0, 150.0 and 450.0 mIU/mL FSH (from human pituitary gland) in porcine serum with sodium azide as a preservative.*DSL-4700 (500 Tubes) contains three sets of calibrators.Anti-FSH [I-125] Reagent:One vial, 11 mL each, containing < 10 μCi (370 kBq) of [I-125]-labeled anti-FSH in a protein-based (BSA) buffer with sodium azide as a preservative.*DSL-4700 (500 Tubes) contains five vials of reagent.Anti-FSH-Coated Tubes:One hundred (100) plastic tubes or five hundred plastic tubes with anti-FSH antibody immobilized to the inside wall of each tube. FSH Controls:Two vials, 1.0 mL each, levels I and II, containing low and high concentrations of FSH (from human pituitary gland) in porcine serum with sodium azide as a preservative.Wash Concentrate:One bottle, 100 mL, containing wash concentrate with sodium azide as a preservative.*DSL-4700 (500 Tubes) contai

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