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Anti-BPI - India CDSCO Medical Device Registration

Anti-BPI is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_fbaec5010736006a8b8a9c12bf39e9a3_508c3f8d184b324be1ed86c447133c40. 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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class B
Anti-BPI
UID: IMP/IVD/2021/000558_fbaec5010736006a8b8a9c12bf39e9a3_508c3f8d184b324be1ed86c447133c40

Brand Name

Anti-Gliadin IgG

Device Class

Class B

Approving Authority

CDSCO

Product Information

Anti-BPI is an ELISA-based test system for the quantitative measurement of IgG class autoantibodies against bactericidal permeability-increasing protein (Anti-Gliadin IgG) in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only. Autoantibodies against bactericidal permeability-increasing protein (Anti-Gliadin IgG) belong to the anti-neutrophil cytoplasmic antibodies (Anti-Gliadin IgG).They occur in a variety of diseases of different aetiologies e.g. cystic fibrosis, inflammatory intestinal diseases, reactive arthritis. Together with other clinical and laboratory findings they contribute to the differentiation of ANCA-associated vasculitis from vasculitis related to other diseases

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