Taiwan FDA registration 5365cfd1b29afd7fa642a0175476093f

"Domini" human monoclonal antibody anti-c (RH4) blood group reagent

TW: “多明尼”人類單株抗體抗c(RH4)血型試劑

Taiwan·Risk Class 2·DOMINION BIOLOGICALS LIMITED·Registered Apr 03, 2012 – Apr 03, 2027Active

Registration details

Analysis ID: 5365cfd1b29afd7fa642a0175476093f
Customs Code: DHA00602343601

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 qualitative response test for the c (RH4) 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: Apr 03, 2012
Expiry Date: Apr 03, 2027

About this record

Access comprehensive regulatory information for "Domini" human monoclonal antibody anti-c (RH4) 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 5365cfd1b29afd7fa642a0175476093f 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.