Taiwan FDA registration 73e68d1881890cc6c91ff85e01cbdd88

"Omon immunomembrane strip method anti-celiac disease antibody spectrum IgG detection reagent

TW: “歐蒙” 免疫膜條法抗乳糜瀉抗體譜IgG檢測試劑
Taiwan flagTaiwan·Risk Class 2·EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·Registered Dec 29, 2020 – Dec 29, 2025Expired
Registration details
Analysis ID
73e68d1881890cc6c91ff85e01cbdd88
Customs Code
DHA05603418108
Company information
Manufacturer Country
Germany
Product details
Intended Use
This product is used for the in vitro qualitative detection of anti-tissue glutaminase (tTG) and gliadin (GAF-3X, gliadin-like fusion peptide) immunoglobulin IgG in human serum or plasma for the diagnosis of gluten-sensitive enteropathy and Dunchenne dermatitis.
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.5660 多發性自體抗體免疫試驗系統
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Dec 29, 2020
Expiry Date
Dec 29, 2025
About this record

Access comprehensive regulatory information for "Omon immunomembrane strip method anti-celiac disease antibody spectrum IgG detection reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 73e68d1881890cc6c91ff85e01cbdd88 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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