Taiwan FDA registration 27af976d56f598a1297b3506cbc7d549

Immuno Concepts ANCA TEST SYSTEM with Ethanol Fixed Human Neutrophile

TW: 伊目康斯特抗中性細胞質自體抗體檢測系統

Taiwan·Risk Class 2·MD·IMMUNO CONCEPTS NA LTD·Registered Oct 16, 2015 – Oct 16, 2025Expired

Registration details

Analysis ID: 27af976d56f598a1297b3506cbc7d549
License Form: Ministry of Health Medical Device Import No. 027883
Customs Code: DHA05602788300

Company information

Manufacturer: IMMUNO CONCEPTS NA LTD
Manufacturer Country: United States
Authorized Representative: EVERLIGHT BIOTECH(TAIWAN) CO., LTD.

Product details

Intended Use: Semi-quantitative detection of anti-neutral cytoplasmic autoantibodies (ANCA) in human serum using indirect immunofluorescent antibody detection.
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C5660 Multiple autologous antibody immunoassay system
Import Information: Imported from abroad

Dates and status

Registration Date: Oct 16, 2015
Expiry Date: Oct 16, 2025

About this record

Access comprehensive regulatory information for Immuno Concepts ANCA TEST SYSTEM with Ethanol Fixed Human Neutrophile in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 27af976d56f598a1297b3506cbc7d549 and manufactured by IMMUNO CONCEPTS NA LTD. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..

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