適應症
快速半定量測定人類血清及尿液檢體中的纖維蛋白/纖維蛋白原裂解產物(FDP)。  
劑型
 
包裝
HA13/30852601:20 Test 
許可證字號
衛部藥製字第015978號 
註銷狀態
註銷日期
2017-01-20  
註銷理由
884 
有效日期
2016-02-09  
發證日期
2006-02-09  
許可證種類
09 
中文品名
"銳盟" 纖維蛋白/纖維蛋白原裂解產物檢測套組 
英文品名
"Remel" Thrombo-Wellcotest Kit 
藥品類別
B 血液學及病理學裝置 
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
DHA00601597802 
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. Latex Suspension (1 dropper bottle): 3ml of a 0.75% suspension of polystyrene latex particles coated with sheep anti-FDP globulin in glycine saline buffer containing 0.1% sodium azide and 0.01% Thiomersal.\n2. Positive Control Serum (1 dropper bottle): 1ml of human serum (non reactive for HBsAg and antibodies to HIV types 1 and 2 (HIV-1 and HIV-2) and HCV),diluted in glycine saline buffer containing 0.1% sodium azide.\n3. Negative Control Serum (1 dropper bottle): 1ml of human serum (non reactive for HBsAg and antibodies to HIV types 1 and 2 (HIV-1 and HIV-2) and HCV),diluted in glycine saline buffer containing 0.1% sodium azide.\n4. Sample Collection Tubes: 20 glass tubes containing soya bean trypsin inhibitor (approximately 3600 NF units per tube) and Bothrops atrox venom (> 10μg/tube) for the collection of 2ml whole blood or urine.\n5. Glycine Saline Buffer (2 dropper bottles): Two bottles each containing 25ml of PH 8.2 containing 0.1% sodium azide.\n
1 Latex Suspension: HA08/30852301-3 mlGlycine Saline Buffer: AD01/30853101-100 mlSample Collection Tube: HA25/30853001-100 tubes