適應症
半定量檢測人類甲狀腺微粒體抗原的自體抗體。  
劑型
 
包裝
AD11/30850501 規格變更為:R30850501。 
許可證字號
衛部藥製字第016033號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2026-02-21  
發證日期
2006-02-21  
許可證種類
09 
中文品名
"銳盟" 甲狀腺微粒體抗原自體抗體檢測套組 
英文品名
"Remel" Thymune-M Test Kit 
藥品類別
C 免疫學及微生物學裝置 
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
DHA00601603301 
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 Cells: freeze-dried equivalent of 3 ml of 1% suspension of aldehyde treated, tanned turkey erythrocytes coated with microsomal antigen dispersed in phosphate buffered saline pH 7.2, containing 5% sucrose, 1.5% normal rabbit serum and 0.01% Bronopol.\n(2) Control Cells: freeze-dried equivalent of 3 ml of a 1% suspension of aldehyde treated, tanned turkey erythrocytes dispersed in phosphate buffered saline pH 7.2, containing 5% sucrose, 1.5% normal rabbit serum and 0.01% Bronopol.\n(3) Diluent: 25 ml of isotonic saline containing normal human serum negative for HBsAg and antibodies to HIV-1 and HIV-2 and HCV, normal turkey serum, human thyroglobulin and 0.1% sodium azide.\n(4) Positive Control Serum: 1.0 ml of diluted rabbit anti-microsomal serum. Contains 0.1% sodium azide.\n(5) Negative Control Serum: 1.0 ml of diluted normal human serum negative for HBsAg and antibodies to HIV-1 and HIV-2 and HCV. Contains 0.1% sodium azide.\n\n