協克黴漿菌 IgG 血清抗體試劑
SeroMP IgG

適應症
酵素免疫分析法測試人類血清中肺炎黴漿菌 IgG 抗體。  
劑型
 
包裝
96 Tests or 192 tests/kit, 以下空白。 
許可證字號
44000013 
註銷狀態
1 
註銷日期
2012-11-29  
註銷理由
838 
有效日期
2010-03-21  
發證日期
2005-03-21  
許可證種類
09 
中文品名
協克黴漿菌 IgG 血清抗體試劑 
英文品名
SeroMP IgG 
藥品類別
C 免疫學及微生物學用裝置 
申請商名稱
協克企業有限公司  
申請商地址
台北市大安區復興南路2段157號12樓之1 
通關簽審文件編號
DHA04400001302 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
SAVYON DIAGNOSTICS LTD. 3 HABOSEM ST. 77610 ASHDOD, ISRAEL IL
成份表
處方標示 成分名稱 含量 單位
1 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
1 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 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