普生安肝碘１２５Ａ

醫療器材許可證 · 許可證字號：衛署醫器製字第R01232號

許可證字號

衛署醫器製字第R01232號

註銷狀態

已註銷

註銷日期

2026/07/28

有效日期

2024/10/13

發證日期

2006/01/10

許可證種類

09

醫療器材級數

3

通關簽審文件編號

DHY005R0123204

中文品名

普生安肝碘１２５Ａ

英文品名

HEPAVIDINE 125 A

效能

放射免疫法，測定A型肝炎抗體ANTI-HAV。

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

1.HAV Ag Beads: One dispenser contains 100 beads coated with human HAV Ag.2.125I‧Anti-HAV Solution: Two bottles, 10ml each or ten bottles, 2ml each with 125I labeled Anti-HAV (Mouse Monoclonal). The maximum radioactivity…展開

1.HAV Ag Beads: One dispenser contains 100 beads coated with human HAV Ag.2.125I‧Anti-HAV Solution: Two bottles, 10ml each or ten bottles, 2ml each with 125I labeled Anti-HAV (Mouse Monoclonal). The maximum radioactivity is 3.8μCi/ml. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.3.Anti-HAV Positive Control: One bottle (0.4ml) human serum containing diluted Anti-HAV dissolved in buffer solution. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.4. HAV Negative Control: One bottle (0.4ml) with normal human serum is free of HAV markers. Preservatives: Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.5.Specimen Diluent: Teo bottle (10ml) contain Phosphate Buffered Saline. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.6.Hepatitis A virus Solution (HAV) : One bottle (10ml) of human HAV in PBS Minimum titer 1:80. Preservatives: 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