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AtheNa Multi-Lyte GBM (Autoimmune Vasculitis) Plus Test System - Taiwan Registration 3c811c9a89818b7d4934db2940fb60d5

Access comprehensive regulatory information for AtheNa Multi-Lyte GBM (Autoimmune Vasculitis) Plus Test System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3c811c9a89818b7d4934db2940fb60d5 and manufactured by ZEUS SCIENTIFIC, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..

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.

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3c811c9a89818b7d4934db2940fb60d5
Registration Details
Taiwan FDA Registration: 3c811c9a89818b7d4934db2940fb60d5
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Device Details

AtheNa Multi-Lyte GBM (Autoimmune Vasculitis) Plus Test System
TW: ๅฎ™ๆ–ฏ่‡ช้ซ”ๅ…็–ซๆ€ง่ก€็ฎก็‚Žๆชข้ฉ—็ณป็ตฑ
Risk Class 2
MD

Registration Details

3c811c9a89818b7d4934db2940fb60d5

Ministry of Health Medical Device Import No. 028305

DHA05602830501

Company Information

United States

Product Details

This product targets quantitative or semi-quantitative detection of IgG antibodies to 3 different antigens (glomerular basement membrane, myeloperoxidase and protease 3) in human serum.

C Immunology and microbiology devices

C5660 Multiple autologous antibody immunoassay system

Imported from abroad

Dates and Status

Mar 17, 2016

Mar 17, 2026