免疫特 2000 弓漿蟲免疫球蛋白M試劑

IMMULITE 2000 Toxoplasma IgM Reagent

衛署醫器輸字第013156號

本站收錄狀態已註銷

有效日期2015 / 10 / 11

醫療器材級數第二等級

這張許可證已註銷（2018/05/21，許可證已逾有效期），以下僅供查閱歷史資料。申請商為 西門子醫療設備股份有限公司。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: 用在IMMULITE 2000 分析儀，定量分析成人血清或EDTA，heparin血漿的弓漿蟲(TOXOPLASMA) IgM抗體。
規格: 200 tests; 600 tests。
主成分: Reagents:
With barcode. 200 beads, coated with partially purified Toxoplasma gondii antigen (inactivated RH strain tachyzoites purified from mouse peritoneum). 11.5 mL buffer solution containing goat anti-human IgG, with preservative. 11.5 mL alkaline phosphatase (bovine calf intestine) conjugated to polyclonal goat anti-human IgM antibody in buffer, with preservative. One vial of lyophilized human serum with IgM reactive to Toxoplasma, in buffer, with preservative. One vial negative control containing lyophilized human serum nonreactive to Toxoplasma, in IMMULITE 2000 IgG/IgM Sample Diluent, with preservative. One vial positive control containing lyophilized human serum with IgM reactive to Toxoplasma in IMMULITE 2000 IgG/IgM Sample Diluent, with preservative. Concentrated (ready-to use) nonhuman protein/buffer matrix, with preservative.

可改用包裝上的完整型號或許可證字號查詢。