普生克肝碘１２５ＭＢ

醫療器材許可證 · 許可證字號：衛署醫器製字第R01237號

許可證字號

衛署醫器製字第R01237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

09000039

醫療器材級數

3

通關簽審文件編號

DHY005R0123701

中文品名

普生克肝碘１２５ＭＢ

英文品名

ANTICORDINE 125 MB

效能

放射性免疫法測定B型肝炎核心抗原IgM抗體 (Anti-HBc IgM)。

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-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 labele…展開

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.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