亞培 "必利盛" 人類免疫不全病毒抗體第一型(M及O型)及第二型檢驗試劑
ABBOTT PRISM HIV O PLUS

適應症
化學冷光免疫分析法定性測試人類血清或血漿中之ANTI-HIV-1(M及O型)及ANTI-HIV-2，篩選用。 
劑型
 
包裝
 
許可證字號
衛部醫器陸輸字第000737號 
註銷狀態
1 
註銷日期
2005-10-31  
註銷理由
824,823 
有效日期
2007-10-16  
發證日期
2002-10-16  
許可證種類
04 
中文品名
亞培 "必利盛" 人類免疫不全病毒抗體第一型(M及O型)及第二型檢驗試劑 
英文品名
ABBOTT PRISM HIV O PLUS 
藥品類別
 
申請商名稱
美商亞培股份有限公司台灣分公司  
申請商地址
台北巿中山區民生東路三段49號5、6樓及51號5、6樓 
通關簽審文件編號
DHA01000073701 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ABBOTT GMBH & CO. KG MAX-PLANCK-RING 2 D-65205 WIESBADEN-DELKENHEIM GERMANY DE
成份表
處方標示 成分名稱 含量 單位
1 1.1 BOTTLE (324 ML) HIV-1/HIV-2 (E.COLI, B. MEGATERIUM, RECOMBINANT) ANTIGEN COATED MICROPARTICLES IN PHOSPHATE BUFFER WITH CHAPS AND PROTEIN STABILIZERS.
1 2.1 BOTTLE (331 ML) ANTI-BIOTIN (MOUSE MONOCLONAL):ACRIDINIUM CONJUGATE IN PHOSPHATE BUFFERED SALINE, WITH TRITON X-100 AND PROTEIN STABILIZER. MINIMUM CONCENTRATION:0.025 UG/ML
1 3.3 BOTTLE (10.4 ML EACH) NEGATIVE CALIBRATOR (HUMAN). RECALCIFIED PLASMA NONREACTIVE FOR HBSAG, HIV-1 AQ, ANTI-HCV AND ANTI-HIV-1/HIV-2.
1 4.3 BOTTLES (10.4 ML EACH) HIV -1 POSITIVE CALIBRATOR (HUMAN) RECALCIFIED, HEAT-INACTIVATED PLASMA REACTIVE FOR ANTI-HIV-1 NONREACTIVE FOR HBSAG AND ANTI-HCV.
1 5.1 BOTTLE (16ML) PROBE 20X CONCENTRATION BIOTINYLATED HIV-1/HIV-2 (E.COLI, RECOMBINANT) ANTIGEN AND SYNTHETIC PEPTIDE IN BORATE BUFFER WITH PROTEIN STABILIZERS.
1 6.3 BOTTLE (10.4 ML EACH) HIV-2 POSITIVE ASSAY CONTROL (HUMAN) RECALCIFIED, HEAT-INACTIVATED PLASMA REACTIVE FOR ANTI-HIV-2, NONREACTIVE FOR HBSAG AND ANTI-HCV.
1 7.1 BOTTLE (306 ML) PROBE DILUENT. BORATE BUFFER WITH CKS LYSATE, CALF SERUM, AND PROTEIN STABILIZERS.
1 1.1 BOTTLE (3364ML) TRANSFER WASH. BORATE BUFFER SALINE
1 2.1 BOTTLE (2794ML) CONJUGATE WASH. TRTS BUFFER
1 3.1 BOTTLE (2258ML)PROBE WASH. TRIS BUFFER.
1 4 BOTTLES (900 ML EACH) ACTIVATOR CONCENTRATE. 0.4% HYDROGEN PEROXIDE/0.06% DIETHYLENE-TRIAMINEPENTA-ACETIC ACID.
1 4 BOTTLES (900 ML EACH) ACTIVATOR DILUENT. 0.3 N SODIUM HYDROXIDE.
1 1.2 BOTTLES (10 ML EACH) POSITIVE CONTROL (HUMAN). PURIFIED ANTI-HBC IGG (CONCENTRATION: 0.9-236 PEI UNITS/ML) AND RECALCIFIED HEAT-INACTIVATED PLASMA REACTIVE FOR HBSAG, ANTI-HCV, ANTI-HIV-1 ANTI-HTLV-1.
1 2.1 BOTTLE (10 ML) SUPPLEMENTAL POSITIVE CONTROL (HUMAN) RECALCIFIED, HEAT-INACTIVATED PLASMA REACTIVE FOR HBSAG, ANTI-HCV, ANTI-HIV-1/HIV-2, AND ANTI-HTLV-II.
1 6 BOTTLES (10 ML EACH) POSITIVE CONTROL (HUAMN). PURFIED ANTI-HBC IGG AND RECALCIFIED, HEAT-INACTIVATED PLASMA REACTIVE FOR HBSAG, ANTI-HCV, ANTI-HIV-1 AND ANTI-HTLV-1.