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EliA RF Positive Controls - Taiwan Registration 136222c57138cb06736856ad9c3d5908

Access comprehensive regulatory information for EliA RF Positive Controls in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 136222c57138cb06736856ad9c3d5908 and manufactured by PHADIA AB. The authorized representative in Taiwan is PHADIA TAIWAN INC..

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136222c57138cb06736856ad9c3d5908
Registration Details
Taiwan FDA Registration: 136222c57138cb06736856ad9c3d5908
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Device Details

EliA RF Positive Controls
TW: ๅฎœ็ซ‹ไบž้กž้ขจๆฟ•ๅ› ๅญ้™ฝๆ€งๅ“็ฎกๆถฒ
Risk Class 2
MD

Registration Details

136222c57138cb06736856ad9c3d5908

Ministry of Health Medical Device Import No. 027344

DHA05602734406

Company Information

Sweden

Product Details

Performance (new models) changes: This product is designed to monitor the performance of in vitro measurements of rheumatoid factor (RF) using the EliA IgM or EliA IgA methodology on the Fadia 100, Fadia 200 and Fadia 250 instruments.

A Clinical chemistry and clinical toxicology

A1660 Quality Control Materials (Analytical and Non-Analytical)

Imported from abroad

Dates and Status

May 29, 2015

May 29, 2025