Taiwan FDA registration 9edbd629268a3e7b9ab4a6bf9051b6eb
"E-free" anti-Fyb blood group reagent (monostrain antibody)
TW: “依免可”抗Fyb血型試劑(單株抗體)
Taiwan·Risk Class 2·IMMUCOR, INC.·Registered Nov 27, 2020 – Nov 27, 2025ExpiredRegistration details
- Analysis ID
- 9edbd629268a3e7b9ab4a6bf9051b6eb
- Customs Code
- DHA05603416306
Company information
- Manufacturer
- IMMUCOR, INC.
- Manufacturer Country
- United States
- Authorized Representative
- Y.H. BIOTEK CO., LTD.
Product details
- Intended Use
- This product uses a direct agglutination test to detect Fyb (FY2) antigen on red blood cells.
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.4020 Analysis of specific tests
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Nov 27, 2020
- Expiry Date
- Nov 27, 2025
About this record
Access comprehensive regulatory information for "E-free" anti-Fyb blood group reagent (monostrain antibody) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9edbd629268a3e7b9ab4a6bf9051b6eb and manufactured by IMMUCOR, INC.. The authorized representative in Taiwan is Y.H. BIOTEK CO., LTD..
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