銳盟 威克絲沙門氏桿菌檢測套組(未滅菌)
- 醫療器材許可證資料集 @ 衛生福利部食品藥物管理署
中文品名銳盟 威克絲沙門氏桿菌檢測套組(未滅菌)的英文品名是Remel Wellcolex Colour Salmonella Test (Non-sterile), 許可證字號是衛署醫器輸壹字第000743號, 有效日期是2025/10/04, 許可證種類是09, 效能是快速乳膠凝集法檢測沙門氏桿菌之血清型。, 主成分略述是Latex Reagent 1\na grey-brown suspension of polystyrene latex particles in buffer containing 0.05% Bronidox® preservative. The latex particles are coa..., 醫器規格是ZC50/30858301: 50 Test;ZC52/30858302: 200 Test, 限制項目是輸 入, 申請商名稱是成信新貿易股份有限公司.
許可證字號 | 衛署醫器輸壹字第000743號 |
註銷狀態 | (空) |
註銷日期 | (空) |
註銷理由 | (空) |
有效日期 | 2025/10/04 |
發證日期 | 2005/10/04 |
許可證種類 | 09 |
舊證字號 | (空) |
醫療器材級數 | 1 |
通關簽審文件編號 | DHA04400074300 |
中文品名 | 銳盟 威克絲沙門氏桿菌檢測套組(未滅菌) |
英文品名 | Remel Wellcolex Colour Salmonella Test (Non-sterile) |
效能 | 快速乳膠凝集法檢測沙門氏桿菌之血清型。 |
劑型 | (空) |
包裝 | (空) |
醫器主類別一 | C 免疫學及微生物學 |
醫器次類別一 | C.3550 沙門氏菌屬血清試劑 |
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 | Latex Reagent 1\na grey-brown suspension of polystyrene latex particles in buffer containing 0.05% Bronidox® preservative. The latex particles are coated with rabbit antibody with the following specificity:-\nRad latex Salmonella group B\nBlue latex Salmonella group C\nGreen latex Salmonella group D1\nLatex Reagent 2\na grey-brown suspension of polystyrene latex particles in buffer containing 0.05% Bronidox® preservative. The latex particles are coated with rabbit antibody with the following specificity:-\nRed latex Vi\nBlue latex Salmonella groups E and G\nGreen latex Salmonella group A.\nRed Positive Control\nKilled bacterial suspension of organisms with Salmonella group B and Vi antigens containing 0.05% Bronidox® and 0.5% formalin as preservative.\nBlue Positive Control\nKilled bacterial suspension of organisms with Salmonella groups C and E antigens containging 0.05% Bronidox® and 0.5% formalin as preservative.\nGreen Positive Control\nKilled bacterial suspension of organisms with Salmonella group A and |
醫器規格 | ZC50/30858301: 50 Test;ZC52/30858302: 200 Test |
限制項目 | 輸 入 |
申請商名稱 | 成信新貿易股份有限公司 |
申請商地址 | 新北市中和區中山路二段348巷10號10樓 |
申請商統一編號 | 86940208 |
製造商名稱 | REMEL EUROPE LIMITED |
製造廠廠址 | REMEL HOUSE CLIIPPER BOULEVARD WEST, CROSSWAYS, DARTFORD, KENT, DA2 6PT, UK |
製造廠公司地址 | (空) |
製造廠國別 | GB |
製程 | (空) |
異動日期 | 2020/06/01 |
製造許可登錄編號 | (空) |
許可證字號衛署醫器輸壹字第000743號 |
註銷狀態(空) |
註銷日期(空) |
註銷理由(空) |
有效日期2025/10/04 |
發證日期2005/10/04 |
許可證種類09 |
舊證字號(空) |
醫療器材級數1 |
通關簽審文件編號DHA04400074300 |
中文品名銳盟 威克絲沙門氏桿菌檢測套組(未滅菌) |
英文品名Remel Wellcolex Colour Salmonella Test (Non-sterile) |
效能快速乳膠凝集法檢測沙門氏桿菌之血清型。 |
劑型(空) |
包裝(空) |
醫器主類別一C 免疫學及微生物學 |
醫器次類別一C.3550 沙門氏菌屬血清試劑 |
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Latex Reagent 1\na grey-brown suspension of polystyrene latex particles in buffer containing 0.05% Bronidox® preservative. The latex particles are coated with rabbit antibody with the following specificity:-\nRad latex Salmonella group B\nBlue latex Salmonella group C\nGreen latex Salmonella group D1\nLatex Reagent 2\na grey-brown suspension of polystyrene latex particles in buffer containing 0.05% Bronidox® preservative. The latex particles are coated with rabbit antibody with the following specificity:-\nRed latex Vi\nBlue latex Salmonella groups E and G\nGreen latex Salmonella group A.\nRed Positive Control\nKilled bacterial suspension of organisms with Salmonella group B and Vi antigens containing 0.05% Bronidox® and 0.5% formalin as preservative.\nBlue Positive Control\nKilled bacterial suspension of organisms with Salmonella groups C and E antigens containging 0.05% Bronidox® and 0.5% formalin as preservative.\nGreen Positive Control\nKilled bacterial suspension of organisms with Salmonella group A and |
醫器規格ZC50/30858301: 50 Test;ZC52/30858302: 200 Test |
限制項目輸 入 |
申請商名稱成信新貿易股份有限公司 |
申請商地址新北市中和區中山路二段348巷10號10樓 |
申請商統一編號86940208 |
製造商名稱REMEL EUROPE LIMITED |
製造廠廠址REMEL HOUSE CLIIPPER BOULEVARD WEST, CROSSWAYS, DARTFORD, KENT, DA2 6PT, UK |
製造廠公司地址(空) |
製造廠國別GB |
製程(空) |
異動日期2020/06/01 |
製造許可登錄編號(空) |
銳盟 威克絲沙門氏桿菌檢測套組(未滅菌)地圖 [ 導航 ]
銳盟 威克絲沙門氏桿菌檢測套組(未滅菌)的地址位於
新北市中和區中山路二段348巷10號10樓