← 返回產品資料庫

⚠️ 此醫材許可證已註銷

狀態:已註銷 日期:2018/06/28

原因:許可證已逾有效期

"依免可" 胚胎流血篩選試劑

🩺 醫材

"Immucor" Fetal Bleed Screening Test

衛署醫器輸字第017856號

醫材分類

2 等級
  • B.7455胎兒血紅素分析

醫器規格

#7892

限制項目

輸 入

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。

醫材資訊

主成分
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. 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. Negative Control (1x2 mL): A 2-4% suspension of group O D-negative red blood cells.
製造商
IMMUCOR, INC.
製造國
US
申請商
永弘科技有限公司
有效日期
2016/12/29
發證日期
2006/12/29

供應藥局

目前尚無登錄供應此品項的藥局資料。