普生克肝碘１２５Ｂ

醫療器材許可證 · 許可證字號：衛署醫器製字第R01234號

許可證字號

衛署醫器製字第R01234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

09000034

醫療器材級數

3

通關簽審文件編號

DHY005R0123408

中文品名

普生克肝碘１２５Ｂ

英文品名

ANTICORDINE 125 B

效能

放射免疫法檢測B型肝炎核心抗體(Anti-HBc)。

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.HBcAg Beads: Five trays each with 20 beads coated with human HBcAg. One spare tray is also included.2.125I‧Anti-HBc Solution: Two bottles, 5ml each 125I labeled Anti-HBc (human) dissolved in protein stabilizer. Th…展開

每套組含：1.HBcAg Beads: Five trays each with 20 beads coated with human HBcAg. One spare tray is also included.2.125I‧Anti-HBc Solution: Two bottles, 5ml each 125I labeled Anti-HBc (human) dissolved in protein stabilizer. The maximum radioactivity was 1.5μCi/ml on iodination day. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.3. Anti-HBc Positive Control: One bottle(2ml) human buffer solution with protein stabilizers. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.4. HB Negative Control: One bottle(3ml) Normal human serum does not contain Anti-HBc and HBsAg markers, but contains protein stabilizers. 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