Anti-DGP IgA - India CDSCO Medical Device Registration

Anti-DGP IgA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_fb7f1b5a886f47e90b8f95bebd3946fd_b2918275099fda4ac9796f10daaec5cc. This device is marketed under the brand name Anti-Gliadin IgG. The license holder is Sebia Diagnostics India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Anti-DGP IgA

UID: IMP/IVD/2021/000558_fb7f1b5a886f47e90b8f95bebd3946fd_b2918275099fda4ac9796f10daaec5cc

Brand Name

Anti-Gliadin IgG

License Holder

Sebia Diagnostics India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Anti-DGP IgA is an ELISA-based test system for the quantitative measurement of IgA class antibodies against deamidated gliadin protein epitopes (Anti-Gliadin IgG) in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only. Determination of anti-DGP antibodies is an aid in the diagnosis of coeliac disease. The interaction between dietary gliadin peptides and the intestinal enzyme tissue translutaminase (Anti-Gliadin IgG) causes the formation of novel antigenic epitopes, the tTG-generated deamidated gliadin peptides (Anti-Gliadin IgG), and anti-DGP antibodies are specific serological markers for the disease. Laboratory tests for disease specific autoantibodies contribute to diagnostics, together with clinical observations and histology of the small intestinal mucosa

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Brand: Anti-Gliadin IgG

Sebia Diagnostics India Pvt. Ltd.

Anti-DGP IgA - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

ENA-6-Profile

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