Taiwan FDA registration c2a5ee64d3efc03cff9108ca15394b0b
“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
Taiwan·Risk Class 2·MD·IMMUNO CONCEPTS NA LTD·Registered Jun 23, 2015 – Jun 23, 2025ExpiredRegistration details
- Analysis ID
- c2a5ee64d3efc03cff9108ca15394b0b
- License Form
- Ministry of Health Medical Device Import No. 027359
- Customs Code
- DHA05602735906
Company information
- Manufacturer
- IMMUNO CONCEPTS NA LTD
- Manufacturer Country
- United States
- Authorized Representative
- EVERLIGHT BIOTECH(TAIWAN) CO., LTD.
Product details
- Intended Use
- Anti-neutral cytoplasmic autoantibodies (ANCA) in human serum were detected by semi-quantitative inter-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
- Jun 23, 2015
- Expiry Date
- Jun 23, 2025
About this record
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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