適應症
以酵素免疫分析法定量人體血清中念珠菌屬抗-甘露聚糖抗體。  
劑型
 
包裝
空白。 
許可證字號
44000806 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2025-10-06  
發證日期
2005-10-06  
許可證種類
09 
中文品名
伯樂亞 念珠菌屬抗甘露聚糖抗原(未滅菌) 
英文品名
Platelia CANDIDA Ab/Ac/Ak(Non-Sterile) 
藥品類別
C 免疫學及微生物學裝置 
申請商地址
台北市松山區南京東路4段126號14樓 
通關簽審文件編號
DHA04400080601 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
BIO-RAD Route de Cassel 59114 Steenvoorde France FR
成份表
處方標示 成分名稱 含量 單位
1 Microplate:\n12 strips of 8 wells sensitized with purified mannan prepared from a partir de C. albicans
1 Concentrated washing solution (10X):\nTRIS-NaCl buffer (pH 7,4), 1% Tween 20\nPreservative : 0.01% de thimerosol
1 Negative control serum :\nHuman serum negative for anti-mannan Ab and tested negative for anti-HIV1 and anti-HIV2 antibodies, HBs antigen and anti-HCV antibody.\nPreservative: < 0.1% sodium azide.
1 Calibrator serum : \nSolution containing human anti-mannan antibodies derived from a serum tested negative for anti-HIV1 and anti-HIV2 antibodies, HBs antigen and anti-HCV antibody, used for preparation of the range points.\nPreservative: < 0.1% sodium azide.
1 Positive control serum :\nHuman serum containing anti-mannan antibodies, tested negative for anti-HIV1 and HIV2 antibodies, HBs antigen and anti-HCV antibody.\nPreservative: <0.1% sodium azide.
1 Conjugate (ready for use) :\nPeroxidase-labelled goat anti-human lg antibody.\nPreservative: 0.01% thimerosal.
1 Sample diluent (ready for use) :\nPreservative: 0.01% thimerosal.
1 TMB substrate buffer (ready for use) :\nCitric acid and sodium acetate solution pH 5.2 containing 0.009% d H2O2 and 4% Dimethylsulfoxide (DMSO)
1 Chromogen TMB solution (concentrated) : \n90% DMSO solution containing 0.6%\nTetramethylbenzidine (TMB)
1 Stopping solution (ready for use) :\n1.5 N sulphuric acid
1 Adhesive films