Taiwan FDA registration aa57afa5e751984c858ff94d2154e09b
Beckman Coulter Total Immunoglobulin E Reagent
TW: 貝克曼庫爾特總免疫球蛋白E試劑
Taiwan·Risk Class 2·BECKMAN COULTER INC.·Registered Feb 09, 2023 – Feb 09, 2028ActiveRegistration details
- Analysis ID
- aa57afa5e751984c858ff94d2154e09b
- Customs Code
- DHA05603615708
Company information
- Manufacturer
- BECKMAN COULTER INC.
- Manufacturer Country
- United States
- Authorized Representative
- BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- This product is used to quantitatively measure total immunoglobulin E (IgE) concentrations in human serum and plasma (lithium heparin, sodium heparin, K2 EDTA, K3 EDTA) on the Beckman Coulter AU/DxC AU Clinical Chemistry Analyzer.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5510 免疫球蛋白A,G,M,D及E免疫試驗系統
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Feb 09, 2023
- Expiry Date
- Feb 09, 2028
About this record
Access comprehensive regulatory information for Beckman Coulter Total Immunoglobulin E Reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number aa57afa5e751984c858ff94d2154e09b and manufactured by BECKMAN COULTER INC.. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).
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