"銳盟" 威克菌 奈瑟氏腦膜炎球菌A,C,Y,W135群檢測套組

醫療器材許可證 · 許可證字號：衛署醫器輸字第015949號

許可證字號

衛署醫器輸字第015949號

註銷狀態

已註銷

註銷日期

2017/01/17

註銷理由

許可證已逾有效期

有效日期

2016/01/26

發證日期

2006/01/26

許可證種類

09

醫療器材級數

2

通關簽審文件編號

DHA00601594905

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

效能

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。

醫器主類別一

C 免疫學及微生物學

醫器次類別一

C.3390 奈瑟氏菌屬直接血清試劑

主成分略述

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.m…展開

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收合

醫器規格

ZL23/30859203: 30 Tests/Kit

限制項目

輸 入

申請商名稱

成信新貿易股份有限公司

申請商地址

新北市中和區中山路二段348巷8號9樓

申請商統一編號

86940208

製造商名稱

REMEL EUROPE LIMITED

製造廠廠址

REMEL HOUSE CLIPPER BOULEVARD WEST, CROSSWAYS, DARTFORD, KENT, DA2 6PT, UK

製造廠國別

GB

異動日期

2017/01/18

製造許可登錄編號

QSD1906

建立時間 2026-09-22 15:59:32 · 更新時間 2026-09-22 15:59:32