Taiwan FDA registration 85cfc580f02a6649bca1fb63dbc9a1ea
"Loren" monoclonal antibody anti-Jka serum reagent
TW: “羅倫” 單株抗體抗Jka血清試劑
Taiwan·Risk Class 2·Lorne Laboratories Limited·Registered Oct 19, 2020 – Oct 19, 2025ExpiredRegistration details
- Analysis ID
- 85cfc580f02a6649bca1fb63dbc9a1ea
- Customs Code
- DHA05603368801
Company information
- Manufacturer
- Lorne Laboratories Limited
- Manufacturer Country
- United Kingdom
- Authorized Representative
- GLORY BIOSCIENCE CO., LTD.
Product details
- Intended Use
- This product is a blood typing reagent that qualitatively determines the presence of Jka antigen on red blood cells of donors or patients requiring blood transfusion.
- 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
- Oct 19, 2020
- Expiry Date
- Oct 19, 2025
About this record
Access comprehensive regulatory information for "Loren" monoclonal antibody anti-Jka serum reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 85cfc580f02a6649bca1fb63dbc9a1ea and manufactured by Lorne Laboratories Limited. The authorized representative in Taiwan is GLORY BIOSCIENCE CO., LTD..
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