普生益肝碘１２５ＢＮ

EIDINE 125 BN

衛署醫器製字第R01235號

本站收錄狀態已註銷

有效日期2024 / 11 / 06

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: 放射免疫分析法測定B型肝炎e抗原(HBeAg)B型肝炎e抗體(Anti-HBe)。
主成分: 每套組含：1.Anti-HBe beads: One dispenser contains 100 beads coated with human antibody to HBe Ag.2.125I‧Anti-HBe Solution: Two bottles, 10ml each or ten bottles, 2ml each with 125I labeled anti-HBe (human) dissolved in protein stabilizer. The maximum radioactivity was 3.5μCi/ml on iodinization day. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin. 3.HBeAg Positive Control: One bottle (2ml) containing HBeAg and HBsAg positive serum dissolved in buffer solution with protein stabilizer. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.4.HB Negative Control: One bottle (3ml) with normal human serum is free of HBeAg, anti-HBe and HBsAg, but contains protein stabilizers. Preservatives: Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.5.Anti-HBe positive control: one bottle (2ml) containing Anti-HBe and HBsAg positive serum sdissolved in buffer solution with protein stabillizer. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.6.Neutralizing solution for anti-HBe: One bottle (10ml) of diluted recalcified human plasma, reactive for HBeAg and HBsAg. reservatives: 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。