Taiwan FDA registration 5fd78534840b388085088a2f8e64bc9e
"Bury" monoclonal antibody anti-Lea identification card
TW: "伯瑞" 單株抗體抗Lea鑑定卡片
Registration details
- Analysis ID
- 5fd78534840b388085088a2f8e64bc9e
- Customs Code
- DHA05603585106
Company information
- Manufacturer
- DIAMED GMBH
- Manufacturer Country
- Switzerland
- Authorized Representative
- Bio-Rad Laboratories Inc., Taiwan Branch (U.S.A.)
Product details
- Intended Use
- Antigen-antibody response is used to detect the Lewis antigen system 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
- Input;; QMS/QSD
Dates and status
- Registration Date
- Sep 07, 2022
- Expiry Date
- Sep 07, 2027
About this record
Access comprehensive regulatory information for "Bury" monoclonal antibody anti-Lea identification card in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5fd78534840b388085088a2f8e64bc9e and manufactured by DIAMED GMBH. The authorized representative in Taiwan is Bio-Rad Laboratories Inc., Taiwan Branch (U.S.A.).
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
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