適應症
利用人體血清或血漿以酵素免疫分析法做為偵測愛滋瘸毒HIV1, HIV2 感染之用。 
劑型
 
包裝
 
許可證字號
衛部醫器陸輸字第000715號 
註銷狀態
註銷日期
2006-09-01  
註銷理由
824,823 
有效日期
2007-07-15  
發證日期
2002-07-15  
許可證種類
04 
中文品名
金克滋愛滋病毒抗原-抗體試劑 
英文品名
GENESCREEN PLUS HIV AG-AB 
藥品類別
 
申請商地址
台北巿松山區南京東路三段338巷5號4樓 
通關簽審文件編號
DHA01000071501 
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 R1: MICROPLATE. 12 STRIPS OF 8 WELLS COATED WITH MAB TO P24 HIV 1 (MOUSE) AND PURIFIED HIV 1 AND HIV 2AGS
1 R2:CONC. WASHING SOLUTON 10X. TRIS NACL BUFFER PH7.4, PRESERVATIVE:THIMEROSAL 0.01%
1 R3:NEGATIVE CONTROL. HEAT INACTIVATED HUMAN PLASMA NEGATIVE FOR HBS AG, HIV AG, ANTI-HIV 1, HIV 2, HCV ABS. PRESERVATIVE: SODIUM AZID<0.1%
1 R4:CUT-OFF CONTROL:HEAT INACTIVATED HUMAN PLASMA POSITIVE FOR ANTI-HIV ABS, NEG. FOR HBS AGS AND ANTI-HCV ABS. PRESERVATIVE: SODIUM AZIDE<0.1%
1 R5:HIV AG POSITIVE CONTROL.PURIFIED HIV 1 AG HEAT INACTIVATED WITH A CHAOTROPIC AGENT, IN SYNTHETIC DILUENT. PRESERVATIVE: PROCLIN 300 0.5%
1 R6:CONJUGATE 1. BIOTINYLATED POLYCLONAL ABS TO P24 HIV 1(SHEEP) COLOR YELLOW-GREEN. PRESERVATIVE: PROCLIN 300 0.5%
1 R7A:CONJUGATE 2. LYOPHOLIZED PEROXIDASE LABELLED AVIDIN AND PURIFIED HIV 1 AND HIV 2 AGS
1 R7B:CONJUGATE 2 DILUENT. SKIMMED MILK SOLUTION COLORED RED. PRESERVATIVE: PROCLIN 300 0.5%
1 R8:PEROXIDASE SUBSTRATE BUFFER: CITRIC ACID AND SODIUM ACETATE SOLUTON PH 4.0 CONTAINING H2O2 (0.015%) AND DMSO(4%)
1 R9:CHROMOGEN. SOLUTION CONTAINING TETRAMETHYL BENZIDINE (YMB)
1 R10:STOPPING SOLUTION. 1 N SULPHURIC ACID SOLUTION ADHESIVE FILMS