普生克肝碘１２５ＭＢ

ANTICORDINE 125 MB

衛署醫器製字第R01237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: 放射性免疫法測定B型肝炎核心抗原IgM抗體 (Anti-HBc IgM)。
主成分: 每套組含：1.Anti-IgM beads: Five trays each with 20 beads coated with purified antibodyto human IgM are packed in plastic bag with desiccant.2.125I‧Anti-HBc Solution: Ten bottles, 1ml each( or 2 bottles, 5ml each) 125I labeled Anti-HBc (Human) dissolved in protein stabilizer. The maximum radioactivity was 5.5μCi/ml on iodination day. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin. 3.IgM anti-HBc Positive Control: One bottle (3.0ml) human serum, containing diluted IgM anti-HBc. It should be used directly and need not to be diluted again. Minimum titer:1:2 Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.4.HB IgM anti-HBc Negative Control: One bottle (4ml) diluted normal human serum contains protein stabilizer. It should be used directly and need not to be diluted again. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.5.Hepatitis B core antigen(HBcAg) Reagent: One bottle (10ml) of human HbcAg in saline and protein stabilizer, Minimum titer 1:64. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.6.Specimen diluent: one bottle (60ml), contains phosphate Buffered saline and protein stabilizer. 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。