Taiwan FDA registration 9e879ece5f081bacff57a274ae02d999

"Domini" human monoclonal antibody anti-E (RH3) blood group reagent

TW: “多明尼”人類單株抗體抗 E(RH3)血型試劑

Taiwan·Risk Class 2·DOMINION BIOLOGICALS LIMITED·Registered Jun 17, 2009 – Jun 17, 2029Active

Registration details

Analysis ID: 9e879ece5f081bacff57a274ae02d999
Customs Code: DHA00602033707

Company information

Manufacturer: DOMINION BIOLOGICALS LIMITED
Manufacturer Country: Canada
Authorized Representative: Y.H. BIOTEK CO., LTD.

Product details

Intended Use: Slide method, test tube method and microdisk method can be used to provide specific and qualitative response tests for E (RH3) antigen of human red blood cells.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.4020 Analysis of specific tests
Import Information: import

Dates and status

Registration Date: Jun 17, 2009
Expiry Date: Jun 17, 2029

About this record

Access comprehensive regulatory information for "Domini" human monoclonal antibody anti-E (RH3) blood group reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9e879ece5f081bacff57a274ae02d999 and manufactured by DOMINION BIOLOGICALS LIMITED. The authorized representative in Taiwan is Y.H. BIOTEK CO., LTD..

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.