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Anti-Gliadin IgG - India CDSCO Medical Device Registration

Anti-Gliadin IgG is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_fce09eac896ba99e1f77b343b594e607_6eecf899c3d0006f5bc1223d448e93ba. 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-Gliadin IgG
UID: IMP/IVD/2021/000558_fce09eac896ba99e1f77b343b594e607_6eecf899c3d0006f5bc1223d448e93ba

Brand Name

Anti-Gliadin IgG

Device Class

Class B

Approving Authority

CDSCO

Product Information

Anti-Gliadin IgG is an ELISA test system for the quantitative measurement of IgG class autoantibodies against gliadin in human serum or plasma. This product is intended for professional in vitro diagnostic use only. Determination of anti-gliadin antibodies is an aid in the diagnosis of gluten related enteropathies, e.g. coeliac 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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