"依免可" 胚胎流血篩選試劑

醫療器材許可證 · 許可證字號：衛署醫器輸字第017856號

許可證字號

衛署醫器輸字第017856號

註銷狀態

已註銷

註銷日期

2018/06/28

註銷理由

許可證已逾有效期

有效日期

2016/12/29

發證日期

2006/12/29

許可證種類

09

醫療器材級數

2

通關簽審文件編號

DHA00601785608

中文品名

"依免可" 胚胎流血篩選試劑

英文品名

"Immucor" Fetal Bleed Screening Test

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。

醫器主類別一

B 血液學、病理學及基因學

醫器次類別一

B.7455 胎兒血紅素分析

主成分略述

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…展開

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.收合

醫器規格

#7892

限制項目

輸 入

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

申請商統一編號

89943003

製造商名稱

IMMUCOR, INC.

製造廠廠址

3130 GATEWAY DRIVE NORCROSS GEORGIA 30071 U.S.A.

製造廠國別

US

異動日期

2018/06/29

製造許可登錄編號

QSD4007

建立時間 2026-09-22 15:59:33 · 更新時間 2026-09-22 15:59:33