普生克肝碘125MB
- 醫療器材許可證資料集 @ 衛生福利部食品藥物管理署
中文品名普生克肝碘125MB的英文品名是ANTICORDINE 125 MB, 許可證字號是衛署醫器製字第R01237號, 有效日期是2024/11/06, 許可證種類是09, 效能是放射性免疫法測定B型肝炎核心抗原IgM抗體 (Anti-HBc IgM)。, 包裝是盒裝, 主成分略述是每套組含: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-HB..., 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R01237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 | 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)。 |
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-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. |
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R01237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)。 |
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-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. |
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 |
普生克肝碘125MB地圖 [ 導航 ]
普生克肝碘125MB的地址位於
新竹縣寶山鄉新竹科學園區創新一路6號