Taiwan FDA registration f7d3b28f60bcdbf6305e29434f26ac44
“EUROIMMUN” EUROLINE Coeliac Disease Profile (IgA)
TW: “歐蒙” 免疫膜條法抗乳糜瀉抗體譜IgA檢測試劑
Taiwan·Risk Class 2·MD·EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·Registered Jul 01, 2020 – Jul 01, 2025ExpiredRegistration details
- Analysis ID
- f7d3b28f60bcdbf6305e29434f26ac44
- License Form
- Ministry of Health Medical Device Import No. 033500
- Customs Code
- DHA05603350006
Company information
- Manufacturer
- EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG
- Manufacturer Country
- Germany
- Authorized Representative
- EUROIMMUN (SOUTH EAST ASIA) PTE. LTD. TAIWAN BRANCH (SINGAPORE)
Product details
- Intended Use
- This product is used for in vitro qualitative detection of anti-tissue glutaminetransferase (tTG) and gliadin (GAF-3X, gliadin-like fusion peptide) immunoglobulin IgA in human serum or plasma for the diagnosis of gluten-sensitive enteropathy and Dunchenne dermatitis.
- Product Type (Level 1)
- C Clinical Chemistry and Clinical Toxicology
- Product Type (Level 2)
- C5660 Multiple autologous antibody immunoassay system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jul 01, 2020
- Expiry Date
- Jul 01, 2025
About this record
Access comprehensive regulatory information for “EUROIMMUN” EUROLINE Coeliac Disease Profile (IgA) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f7d3b28f60bcdbf6305e29434f26ac44 and manufactured by EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG. The authorized representative in Taiwan is EUROIMMUN (SOUTH EAST ASIA) PTE. LTD. TAIWAN BRANCH (SINGAPORE).
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