MEDCHECK許可證索引
衛署醫器輸壹字
許可證編號000013
許可證編號000013
輸入器材
醫療器材許可證 ／ 輸入器材
協克黴漿菌 IgG 血清抗體試劑
SeroMP IgG
衛署醫器輸壹字第000013號
本站收錄狀態已註銷
有效日期2010 / 03 / 21
醫療器材級數第一等級
這張許可證已註銷（2012/11/29，許可證已逾有效期），以下僅供查閱歷史資料。 申請商為 協克企業有限公司。 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
- 衛署醫器輸壹字第000013號
- 申請商
- 協克企業有限公司 （查看此申請商全部許可證）
- 統一編號
- 23425872
- 申請商地址
- 台北市大安區復興南路2段157號12樓之1
- 發證日期
- 2005 / 03 / 21
- 有效日期
- 2010 / 03 / 21
- 限制項目
- 輸 入
- 資料異動日期
- 2013 / 05 / 29
效能與規格
- 效能
- 酵素免疫分析法測試人類血清中肺炎黴漿菌 IgG 抗體。
- 規格
- 96 Tests or 192 tests/kit, 以下空白。
- 主成分
- 9.P100-calibrator:A ready-to-use M.pneumoniae IgG high positive human serum. Contains 100BU/ml of IgG (arbitary binding units.)Contains less than 0.05% Proclin as a preservative. 96 Tests--1 vial, 0.75ml 192 Tests--1 vial, 1.25ml10.Concentrated HRP-Conjugate (300X):Horseradish peroxidase (HRP) conjugated anti-human IgG (gamma chain specific). Contains less than 0.05% Proclin as a preservative. 96 Tests--1 vial, 0.2ml 192 Tests-1 vial, 0.2ml11.TMB-Substrate:A ready-to-use solution. Contains 3,3',5,5'-tetramethylbenzidine as a chromogen and peroxide as a substrate. 96 Tests--1 Bottle, 14ml 1 Bottle 192 Tests--1 Bottle 24ml12.Stop Solution:A ready-to-use solution. Contains 1M H2SO4. 96 Tests--1 Bottle 15ml, 192 Tests--1 Bottle 30ml13.Plate Cover:96 Tests--1 Unit 192 Tests--2 Units
5.Positive Control:A ready-to-use M.penumoniae IgG positive human serum. Contains less than 0.05% Proclin and less than 0.1% sodium azide as preservatives. 96 Tests--1 vial, 0.75ml 192 Tests--1 vial, 1.25ml6.Negative Control:A ready-to-use M.pneumoniae IgG negative human serum. Contains less than 0.05% Proclin and less than 0.1% sodium azide as preservatives. 96 Tests--1 vial, 0.75ml 192 Tests--1 vial, 1.25ml7.P10-calibrator:A ready-to-use M.pneumoniae IgG low positive human serum-Contains 10BU/ml of IgG (arbitrary binding units). Contains less than 0.1% Sodium azide and less than 0.05% Proclin as preservatives. 96 Tests--1 vial, 0.75ml 192 Tests--1 vail ,1.25ml 8.P50-calibrator:A ready-to-use M.penumoniae IgG medium positive human serum. Contains 50BU/ml of IgG (arbitrary binding units) Contains less than 0.1% Sodium Azide and less than 0.05% Proclin as preservatives. 96 Tests--1 vial, 1.75ml 192 Tests--1 vial, 1.25ml
1.M.pneumoniae antigen coated microtiter plate:96 break apart well (8x12) coated with M.pneumoniae antigens, packed in an aluminum pouch containing a desiccant card. 96 Tests--1 Plate 192 Tests--2 Plates2.Concentrated wash buffer (20X):A PBS-Tween buffer96 Tests--1 bottle, 100ml 192 Tests--2 bottles, 100ml each3.Serum Diluent (blue):A ready-to-use buffer solution. Contains less than 0.05% Proclin as a preservative.96 Tests--1 bottle, 30ml 192 Tests--1 bottle, 60ml each4.Conjugate Diluent (green):A ready-to-use buffer solution. Contains less than 0.05% Proclin as p preservative. 96 Tests--1 Bottle, 40ml 192 Tests--1 Bottle, 80ml
製造廠
- 製造商
- SAVYON DIAGNOSTICS LTD.
- 國別
- 以色列
- 廠址
- 3 HABOSEM ST. 77610 ASHDOD, ISRAEL
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