適應症
用於偵測為D-陰性的母體於分娩後,是否存有D-陽性紅血球。  
劑型
 
包裝
#7892 
許可證字號
衛部藥製字第017856號 
註銷狀態
註銷日期
2018-06-28  
註銷理由
838 
有效日期
2016-12-29  
發證日期
2006-12-29  
許可證種類
09 
中文品名
"依免可" 胚胎流血篩選試劑 
英文品名
"Immucor" Fetal Bleed Screening Test 
藥品類別
B 血液學及病理學裝置 
申請商名稱
永弘科技有限公司  
申請商地址
台北市士林區文林路765號3樓之10 
通關簽審文件編號
DHA00601785608 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
IMMUCOR, INC. 3130 GATEWAY DRIVE NORCROSS GEORGIA 30071 U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 Anti-D serum (Chemically Modified; 1x5 mL): A serum containing reduced and alkylated IgG anti-D, suitable diluted in a proprietary diluent containing tris (hydroxymethyl)-aminomethane buffer and bovine albumin to achieve the appropriate level of potency for the test procedure as described. Any Bovine Albumin used in the manufacture of this product is sourced from donor animals of United States origin that has been inspected and certified by US Veterinary Service inspectors to be disease-free. This ruminant-based product is deemed to have a low-TSE (Transmissible Spongiform Encephalopathy) risk. Contains 0.1% sodium azide as preservative.
1 Indicator Cells (1x5 mL): An approximate 0.5% suspension of ficin-treated group O red blood cells obtained from a donor of the DcE(R2R2) phenotype.\nPositive Control (1x2 mL): A 2-4% suspension of red blood cells comprising approximately 99.4% of group O D-negative cells and approximately 0.6% group O D-positive cells obtained from a donor having heterozygous expression of the D antigen.
1 Negative Control (1x2 mL): A 2-4% suspension of group O D-negative red blood cells.