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"Omon immunomembrane strip method anti-celiac disease antibody spectrum IgG detection reagent - Taiwan Registration 73e68d1881890cc6c91ff85e01cbdd88

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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73e68d1881890cc6c91ff85e01cbdd88
Registration Details
Taiwan FDA Registration: 73e68d1881890cc6c91ff85e01cbdd88
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Device Details

"Omon immunomembrane strip method anti-celiac disease antibody spectrum IgG detection reagent
TW: โ€œๆญ่’™โ€ ๅ…็–ซ่†œๆขๆณ•ๆŠ—ไนณ็ณœ็€‰ๆŠ—้ซ”่ญœIgGๆชขๆธฌ่ฉฆๅŠ‘
Risk Class 2

Registration Details

73e68d1881890cc6c91ff85e01cbdd88

DHA05603418108

Product Details

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.

C Immunology and microbiology

C.5660 ๅคš็™ผๆ€ง่‡ช้ซ”ๆŠ—้ซ”ๅ…็–ซ่ฉฆ้ฉ—็ณป็ตฑ

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Dec 29, 2020

Dec 29, 2025