適應症
快速乳膠檢測法定性偵測體液或在血液培養中的奈瑟氏腦膜炎(腦膜炎球菌)A,C,Y,W135群的抗原。  
劑型
 
包裝
ZL23/30859203: 30 Tests/Kit 
許可證字號
衛部藥製字第015949號 
註銷狀態
註銷日期
2017-01-17  
註銷理由
838 
有效日期
2016-01-26  
發證日期
2006-01-26  
許可證種類
09 
中文品名
"銳盟" 威克菌 奈瑟氏腦膜炎球菌A,C,Y,W135群檢測套組 
英文品名
"Remel" Wellcogen N. meningitidis ACY W135 Kit 
藥品類別
C 免疫學及微生物學裝置 
申請商地址
新北市中和區中山路二段348巷8號9樓 
通關簽審文件編號
DHA00601594905 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
REMEL EUROPE LIMITED REMEL HOUSE CLIPPER BOULEVARD WEST, CROSSWAYS, DARTFORD, KENT, DA2 6PT, UK GB
成份表
處方標示 成分名稱 含量 單位
1 1. Test Latex (1 dropper bottle): 0.5% suspension of polystyrene latex \nparticles in glycine saline buffer, pH 8.2 containing 0.1% sodium azide as preservative. The latex particles are coated with rabbit antibody to N.meningitidis antigens of group A,C,Y and W135.\n2. Control Latex (1 dropper bottle): 0.5% suspension of polystyrene \nlatex particles in glycine saline buffer, pH 8.2 containing 0.1% sodium azide as preservative. The latex particles are coated with \nnon-immune rabbit globulins.\n3. Polyvalent Positive Control (1 bottle): Freeze-dried bacterial \nextracts including antigen from a representative strain of N.meningitidis group C. Contains 1.0% thiomersal before reconstitution and 0.06% when reconstituted.\n4. Negative Control (1 dropper bottle): Glycine saline buffer, pH 8.2. \nContains 0.05% Bronidox? as preservative.\n5. Disposable Reaction Cards (1 pack)\n