“銳盟”威克菌*細菌抗原檢測套組
“Remel” Wellcogen* Bacterial Antigen Kit

適應症
威克菌*細菌抗原鑑定套組提供一系列快速乳膠試劑用來定量檢測B群鏈球菌(Strptococcus group B)、B型嗜血桿菌(Haemophilus influenzxa type b)、肺炎鏈球菌(Streptococcus pneumoniae)、奈瑟氏腦膜炎球菌(Neisseria meningitis) A、B、C、Y 或W135群及感染時出現在腦脊髓液中的大腸桿菌(Escherechia coli )K1型。此套組也可檢測在其他體液或血液培養上清液中以上病菌的抗原和培養基培養的奈瑟氏腦膜炎B群或大腸桿菌K1型。  
劑型
 
包裝
ZL26/30859602: 30 Test 規格變更為：R30859602。 
許可證字號
衛部藥製字第015307號 
註銷狀態
0 
註銷日期
 
註銷理由
 
有效日期
2025-12-07  
發證日期
2005-12-07  
許可證種類
09 
中文品名
“銳盟”威克菌*細菌抗原檢測套組 
英文品名
“Remel” Wellcogen* Bacterial Antigen Kit 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
台灣賽默飛世爾科技股份有限公司  
申請商地址
臺北市內湖區洲子街85號6樓之1 
通關簽審文件編號
DHA00601530704 
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 Test Latexes: 0.5% suspensions of polystyrene latex particles in buffer containing 0.05% Bronidox and/or 0.1% sodium azide as preservative. The latex particles are coated with the appropriate rabbit antibody, as labeled, except for the N. meningitidis group B/E.coli K1 reagent, which is coated with murine monoclonal antibody. \n1. Strep B Test Latex (1 dropper bottle)\n2. H. influenzae b Test Latex (1 dropper bottle)\n3. S. pneumoniae Test Latex (1 dropper bottle)\n4. N. meningitidis ACY W135 Test Latex (1 dropper bottle)\n5. N. meningitidis B/E. coli K1 Test Latex (1 dropper bottle)
1 6-10 Control Latex (5 dropper bottles)\nControl Latexes: 0.5% suspensions of polystyrene latex particles in buffer containing 0.05% Bronidox and/or 0.1% sodium azide as preservative. The latex particles are coated with an appropriate preparation of rabbit globulin or in the case of the N. meningitidis group B/E.coli K1 latex, a murine monoclonal antibody raised against Bordetella bronchiseptica.\n11. Polyvalent Positive Control: Freeze-dried bacterial extracts containing antigens from representative strains of each bacterial species for which latex is provided. Contains 1.0% thiomersal before reconstitution and 0.02% when reconstituted. \n12. Negative Control: Glycine saline buffer, pH8.2. Contains 0.05% Bronidox as preservative.