Taiwan FDA registration 6102b3241533d132738789d770329c8c
"Bury" monoclonal antibody RhD and phenotypic identification card
TW: “伯瑞” 單株抗體RhD及表現型鑑定卡片
Registration details
- Analysis ID
- 6102b3241533d132738789d770329c8c
- Customs Code
- DHA05603435808
Company information
- Manufacturer
- DIAMED GMBH
- Manufacturer Country
- Switzerland
- Authorized Representative
- Bio-Rad Laboratories Inc., Taiwan Branch (U.S.A.)
Product details
- Intended Use
- Human blood samples are tested to identify Rh blood group system antigens C (RF2), c (RH4), D (RH1), E (RH3), and e (RH5) expressed 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
- Feb 04, 2021
- Expiry Date
- Feb 04, 2026
About this record
Access comprehensive regulatory information for "Bury" monoclonal antibody RhD and phenotypic 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 6102b3241533d132738789d770329c8c and manufactured by DIAMED GMBH. The authorized representative in Taiwan is Bio-Rad Laboratories Inc., Taiwan Branch (U.S.A.).
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