"依免可" 胚胎流血篩選試劑

"Immucor" Fetal Bleed Screening Test

衛署醫器輸字第017856號

本站收錄狀態已註銷

有效日期2016 / 12 / 29

醫療器材級數第二等級

這張許可證已註銷（2018/06/28，許可證已逾有效期），以下僅供查閱歷史資料。申請商為 永弘科技有限公司。以下整理許可證、規格與製造廠資料，供核對產品身分使用。

許可證資料依公開資料欄位整理

效能: 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。
規格: #7892
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.
Positive 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.

可改用包裝上的完整型號或許可證字號查詢。