MEDCHECK許可證索引
衛署醫器輸字
許可證編號010730
許可證編號010730
輸入器材
醫療器材許可證 ／ 輸入器材
亞培 "妙芮絲" B型肝炎表面抗體檢驗試劑
MUREX ANTI-HBS
衛署醫器輸字第010730號
本站收錄狀態已註銷
有效日期2014 / 06 / 23
醫療器材級數未載明
這張許可證已註銷（2018/08/09，未展延而逾期者），以下僅供查閱歷史資料。 申請商為 美商亞培股份有限公司台灣分公司。 以下整理許可證、規格與製造廠資料，供核對產品身分使用。
許可證資料 依公開資料欄位整理
- 許可證字號
- 衛署醫器輸字第010730號
- 申請商
- 美商亞培股份有限公司台灣分公司 （查看此申請商全部許可證）
- 統一編號
- 30961216
- 申請商地址
- 台北市中山區民生東路三段49號5樓、6樓及51號6樓
- 發證日期
- 2004 / 06 / 23
- 有效日期
- 2014 / 06 / 23
- 限制項目
- 輸 入
- 資料異動日期
- 2019 / 08 / 12
效能與規格
- 效能
- 酵素免疫分析法，用於偵測血清或血漿中之B型肝炎表面抗體。
- 規格
- 96 TESTE OR 480 TESTS。詳如中文仿單核定本。
- 主成分
- 7.CONJUGATE ONE BOTTLE OR FOUR BOTTLES CONTAINING HEAT INACTIVATED HBSAG (AD AND AY SUBTYPES) CONJUGATED TO HORSERADISH PEROXIDASE DILUTED IN A BUFFER CONTAINING BOVINE PROTEIN AND STABILISERS. CONTAINS 0.025% PROCLIN 300 PRESERVATIVE.
10.WASH FLUID ONE BOTTLE OR TWO BOTTLES CONTAINING 125ML OF 20 TIMES WORKING STRENGTH GLYCINE/BORATE WASH FLUID. CONTAINS 0.2% BRONIDOX PRESERVATIVE.
6.1000MIU/ML STANDARD ONE BOTTLE CONTAINING 1000MIU/ML ANTI-HBS IN A BUFFER CONTAINING BOVINE PROTEIN. CONTAINS 0.05% BRONIDOX AND 0.02% SODIUM AZIDE AS PRESERVATIVES.
2.ASSAY DILUENT ONE BOTTLE OR FIVE BOTTLES OF BUFFER CONTAINING BOVINE PROTEIN. CONTAINS 0.05% BRONIDOX PRESERVATIVE.
8.SUBSTRATE DILUENT ONE BOTTLE CONTAINING A COLOURLESS SOLUTION OF TRI-SODIUM CITRATE AND HYDROGEN PEROXIDE.
3.SAMPLE DILUENT ONE BOTTLE OF BUFFER CONTAINING BOVINE PROTEIN. CONTAINS 0.05%BRONIDOX AND 0.02% SODIUM AZIDE AS PRESERVATIVES.
1.ANTIGEN COATED WELLS ONE PLATE OR FIVE PLATES MADE UP OF 96 MICROWELLS COATED WITH HUMAN HBSAG(AD AND BY SUBTYPES).
4.NEGATIVE CONTROL ONE BOTTLE OF HUMAN SERUM NON-REACTIVE FOR HBSAG AND ANTIBODIES TO HIV TYPES 1 AND 2 (HIV-1, HIV-2), HCV, AND HBSAG. CONTAINS 0.05%BRONIDOX PRESERVATIVE.
9.SUBSTRATE CONCENTRATE ONE BOTTLE CONTAINING 3,3'5,5'-TETRAMETHYLBENZIDINE (TMB) AND STABILISERS IN A PINK SOUTION.
5.CUT-OFF CONTROL (10MIU/ML STANDARD)ONE BOTTLE CONTAINING 10MIU/ML ANTI-HBS DILUTED IN A BUFFER CONTAINING BOVINE PROTEIN. CONTAINS 0.05% BRONIDOX AND 0.02% SODIUM AZIDE AS PRESERVATIVES.
製造廠
- 製造商
- MUREX BIOTECH LTD.
- 國別
- 英國
- 廠址
- CENTRAL ROAD TEMPLE HILL DARTFORD KENT DAL 5LR U.K.
找的不是這個型號？
可改用包裝上的完整型號或許可證字號查詢。