普生正肝碘１２５Ｂ

SURDINE 125 B

衛署醫器製字第R01238號

本站收錄狀態已註銷

有效日期2024 / 11 / 07

醫療器材級數第三等級

這張許可證已註銷（2026/07/28），以下僅供查閱歷史資料。申請商為 普生股份有限公司。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: 放射免疫法檢測B型肝炎表面抗原HBsAg。
規格: 詳如中文仿單核定本（原94.4.7核定之中文仿單核定本予以作廢）。以下空白。
主成分: 每套組含：1.Anti-HBs Beads: Five trays each with 20 beads coated with mouse monoclonal antibody to HBsAg. One spare tray is also included.2.125I‧Anti-HBs Solution: Two bottles, 5ml each 125I labeled Anti-HBs (guinea pig) dissolved in protein stabilizer. The maximum radioactivity was 2.5 μCi/ml on iodination day. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.3.HBsAg Positive Control: One bottle (2ml) containing 32 ng/ml. of HBsAg of adsubtype dissolved in buffer solution with protein stabilizers. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.4.HB Negative Control: One bottle (3ml) Normal human serum does not contain HB markers, but contains protein stabilizers. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.

可改用包裝上的完整型號或許可證字號查詢。