聯信人類免疫缺乏病毒1型和2型抗體酵素免疫診斷試劑盒 UBI HIV-1/2 EIA @ 藥要看

聯信人類免疫缺乏病毒1型和2型抗體酵素免疫診斷試劑盒
UBI HIV-1/2 EIA

適應症: 酵素免疫分析法定性測試人體血清或血漿內之ANTI-HIV1/2 ANTIBODIES,篩檢用。
劑型: 671診斷用試劑
包裝
用法用量
包裝: ＴＥＳＴＳ?ＫＩＴ
形狀
特殊劑型
顏色
特殊氣味
刻痕
外觀尺寸
標註一
標註二
許可證字號: 衛署菌疫製字第000116號
註銷狀態: 1
註銷日期: 2004-03-12
註銷理由: 以醫療器材列管,證別變更
有效日期: 2007-01-11
發證日期: 2002-01-11
許可證種類: 菌　疫
舊證字號
通關簽審文件編號: DHA00900011603
中文品名: 聯信人類免疫缺乏病毒1型和2型抗體酵素免疫診斷試劑盒
英文品名: UBI HIV-1/2 EIA
藥品類別: 由醫師或檢驗師使用
管制藥品分類級別
申請商名稱: 永信藥品工業股份有限公司
申請商地址: 台中市大甲區中山路一段１１９１號
申請商統一編號
異動日期: 2004-03-24
資料更新時間: 2020-02-26
國際條碼
健保代碼
相關連結: 藥物外觀仿單資料外盒/標籤/條碼

製造商
名稱	廠址	公司地址	國別	製程
永信藥品工業股份有限公司台中幼獅廠	台中市大甲區工七路9號、工九路27號		TW

成份表
處方標示	成分名稱	含量	單位
	2.1 ML HIV-2 弱陽性對照 (HIV-2 EIA WEAKLY REACTIVE CONTROL): 1 瓶 INACTIVATED HUMAN SERUM THAT HAS A LOW TITER OF HIV-2 ANTIBODIES, DILUTED IN NORMAL HUMAN SERUM, CONTAINING 0.1% SODIUM AZIDE AND 0.01% GENTAMICIN. ATORE AT 2~8°C.	0
	5.30 ML 酵素結合物稀釋液 (CONIUGATE DILUENT) :1 瓶 PHOSPHATE BUFFERED SALINE SOLUTION CONTAINING SURFACTANT AND HEAT-TREATED NORMAL GOAT SERUM, WITH 0.01% GENTAMICIN AS A PRESERVATIVE. STORE AT 2~8°C.	0
	8.150 ML 濃縮洗滌液 (WASH BUFFER CONCENTRATE, 25 X): 1 瓶 A 25 X CONCENTRATE OF PHOSPHATE BUFFERED SALINE WITH SURFACTANT. STORE AT 2~30°C.	0
	4.45 ML 樣品稀釋液 (HIV EIA SPECIMEN DILUENT): 1 瓶 PHOSPHATE BUFFERED SALINE SOLUTION CONTAINING SURFACTANT, HEAT-TREATED NORMAL GOAT SERUM, CASEIN, AND BOVINE SERUM ALBUMIN. STORE AT 2~8°C.	0
	9. 0.4 ML HIV-1/2 酵素結合物 (HIV-1/2 HRP-CONJUGATE): 1 瓶 HORSERADISH PEROXIDASE-CONJUGATED GOAT ANTI-HUMAN IGG ANTIBODIES, WITH 0.01% GENTAMICIN AND 0.05% 4-DIMETHYLAMINOANTIPYRINE. STORE AT 2~8°C.	0
	7.25 ML 終止液 (STOP SOLUTION): 1 瓶 DILUTED SULFURIC ACID SOLUTION (1.0M H2SO4). STORE AT 2~30°C.	0
	6.25 ML TMB 受質溶液(TMB SUBSTRATE SOLUTION): 1 瓶 3,3',5,5,-TETRAMETHYLBENZIDINE (TMB)DISSOLVED IN CITRATE-PHOSPHATE BUFFER AND H2O2 SOLUTION. STORE AT 2~8°C.	0
	3.1 ML 陰性對照 (NON-REACTIVE CONTROL):1 瓶 INACTIVATED NORMAL HUMAN SERUM, WHICH IS NON-REACTIVE FOR HEPATITIS B SURFACE ANTIGEN, HIV-1/2 ANTIBODIES, HTLV-I/II ANTIBODIES AND HEPATITIS C ANTIBODIES. CONTAINS PRESERVATIVES: 0.1% S	0
	1.1 ML HIV-1 強陽性對照 (HIV-1 EIA STRONGLY REACTIVE CONTROL): 1 瓶 INACTIVATED NORMAL HUMAN SERUM THAT HAS A HIGH TITER OF HIV-1 ANTIBODIES, DILUTED IN NORMAL HUMAN SERUM, CONTAINING 0.1% SODIUM AZIDE AND 0.01% GENTAMICIN AS PRESE	0
	10.96 孔 HIV-1/2 反應盤 (HIV-1/2 PLATE, 96 WELLS): 2 盤 EACH PLATE WELL CONTAINS ADSORBED SYNTHETIC HIV-1, HIV-2, AND HIV-1 SUBTYPE O PEPTIDES. STORE AT 2~8°C SEALED WITH SEDICCANT.	0