普生益肝碘125BN
- 醫療器材許可證資料集 @ 衛生福利部食品藥物管理署
中文品名普生益肝碘125BN的英文品名是EIDINE 125 BN, 許可證字號是衛署醫器製字第R01235號, 有效日期是2024/11/06, 許可證種類是09, 效能是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)。, 包裝是盒裝, 主成分略述是每套組含: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 b..., 申請商名稱是普生股份有限公司.
許可證字號 | 衛署醫器製字第R01235號 |
註銷狀態 | (空) |
註銷日期 | (空) |
註銷理由 | (空) |
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)。 |
劑型 | (空) |
包裝 | 盒裝 |
醫器主類別一 | B 血液學、病理學及基因學 |
醫器次類別一 | (空) |
醫器主類別二 | (空) |
醫器次類別二 | (空) |
醫器主類別三 | (空) |
醫器次類別三 | (空) |
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 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. |
醫器規格 | (空) |
限制項目 | (空) |
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 |
製造廠公司地址 | (空) |
製造廠國別 | TW |
製程 | (空) |
異動日期 | 2023/08/22 |
製造許可登錄編號 | GMP0406 |
許可證字號衛署醫器製字第R01235號 |
註銷狀態(空) |
註銷日期(空) |
註銷理由(空) |
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)。 |
劑型(空) |
包裝盒裝 |
醫器主類別一B 血液學、病理學及基因學 |
醫器次類別一(空) |
醫器主類別二(空) |
醫器次類別二(空) |
醫器主類別三(空) |
醫器次類別三(空) |
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 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. |
醫器規格(空) |
限制項目(空) |
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 |
製造廠公司地址(空) |
製造廠國別TW |
製程(空) |
異動日期2023/08/22 |
製造許可登錄編號GMP0406 |
普生益肝碘125BN地圖 [ 導航 ]
普生益肝碘125BN的地址位於
新竹縣寶山鄉新竹科學園區創新一路6號