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“Immuno Concepts” ANCA TEST SYSTEM with Formalin Fixed Human Neutrophils - Taiwan Registration c2a5ee64d3efc03cff9108ca15394b0b

Access comprehensive regulatory information for “Immuno Concepts” ANCA TEST SYSTEM with Formalin Fixed Human Neutrophils in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c2a5ee64d3efc03cff9108ca15394b0b and manufactured by IMMUNO CONCEPTS NA LTD. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..

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c2a5ee64d3efc03cff9108ca15394b0b
Registration Details
Taiwan FDA Registration: c2a5ee64d3efc03cff9108ca15394b0b
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Device Details

“Immuno Concepts” ANCA TEST SYSTEM with Formalin Fixed Human Neutrophils
TW: “伊目康斯特” 抗中性細胞質自體抗體檢測系統
Risk Class 2
MD

Registration Details

c2a5ee64d3efc03cff9108ca15394b0b

Ministry of Health Medical Device Import No. 027359

DHA05602735906

Company Information

United States

Product Details

Anti-neutral cytoplasmic autoantibodies (ANCA) in human serum were detected by semi-quantitative inter-immunofluorescent antibody detection.

C Immunology and microbiology devices

C5660 Multiple autologous antibody immunoassay system

Imported from abroad

Dates and Status

Jun 23, 2015

Jun 23, 2025