普生益肝碘１２５ＢＮ

醫療器材許可證 · 許可證字號：衛署醫器製字第R01235號

許可證字號

衛署醫器製字第R01235號

註銷狀態

已註銷

註銷日期

2026/07/28

有效日期

2024/11/06

發證日期

2005/01/10

許可證種類

09

舊證字號

09000046

醫療器材級數

3

通關簽審文件編號

DHY005R0123500

中文品名

普生益肝碘１２５ＢＮ

英文品名

EIDINE 125 BN

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)。

包裝

盒裝

醫器主類別一

B 血液學、病理學及基因學

主成分略述

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 prote…展開

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.收合

申請商名稱

普生股份有限公司

申請商地址

新竹縣寶山鄉新竹科學園區創新一路6號

申請商統一編號

47299918

製造商名稱

普生股份有限公司

製造廠廠址

新竹縣寶山鄉新竹科學園區創新一路6號

製造廠國別

TW

異動日期

2026/07/31

製造許可登錄編號

GMP0406

建立時間 2026-09-22 15:59:32 · 更新時間 2026-09-22 15:59:32