Taiwan FDA registration 04de229bed2db56680b3eda7b636b7b5
“Dominion” NOVACLONE Anti-Mia Murine Monoclonal IgG Typing Reagent
TW: “多明尼” 抗Mia鼠單株抗體IgG血型試劑
Taiwan·Risk Class 2·MD·DOMINION BIOLOGICALS LIMITED·Registered Sep 05, 2018 – Sep 05, 2028ActiveRegistration details
- Analysis ID
- 04de229bed2db56680b3eda7b636b7b5
- License Form
- Ministry of Health Medical Device Import No. 031448
- Customs Code
- DHA05603144807
Company information
- Manufacturer
- DOMINION BIOLOGICALS LIMITED
- Manufacturer Country
- Canada
- Authorized Representative
- Y.H. BIOTEK CO., LTD.
Product details
- Intended Use
- This product uses a test-tube test to qualitatively detect the relevant Mia antigen on human red blood cells.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B9175 Automated Blood Sorting and Antibody Testing System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Sep 05, 2018
- Expiry Date
- Sep 05, 2028
About this record
Access comprehensive regulatory information for “Dominion” NOVACLONE Anti-Mia Murine Monoclonal IgG Typing Reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 04de229bed2db56680b3eda7b636b7b5 and manufactured by DOMINION BIOLOGICALS LIMITED. The authorized representative in Taiwan is Y.H. BIOTEK CO., LTD..
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