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EliA ANCA/GBM Positive Controls - Taiwan Registration b38cf62171dd4d3e71b896169cd20b1a

Access comprehensive regulatory information for EliA ANCA/GBM 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 b38cf62171dd4d3e71b896169cd20b1a and manufactured by PHADIA AB. The authorized representative in Taiwan is PHADIA TAIWAN INC..

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b38cf62171dd4d3e71b896169cd20b1a
Registration Details
Taiwan FDA Registration: b38cf62171dd4d3e71b896169cd20b1a
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Device Details

EliA ANCA/GBM Positive Controls
TW: ๅฎœ็ซ‹ไบžANCA/GBM้™ฝๆ€งๅ“็ฎกๆถฒ
Risk Class 2
MD

Registration Details

b38cf62171dd4d3e71b896169cd20b1a

Ministry of Health Medical Device Import No. 027547

DHA05602754707

Company Information

Sweden

Product Details

This product is designed to monitor the performance of in vitro assays of ANCA/GBM antibodies using the ILIA IgG methodology in the Fadia 100 and Fadia 250 instruments.

A Clinical chemistry and clinical toxicology

A1660 Quality Control Materials (Analytical and Non-Analytical)

Imported from abroad

Dates and Status

Aug 11, 2015

Aug 11, 2025