Anti-BPI
- UID
- IMP/IVD/2021/000558_fbaec5010736006a8b8a9c12bf39e9a3_508c3f8d184b324be1ed86c447133c40
- Device class
- Class B
- Brand name
- Anti-Gliadin IgG
- License holder
- Sebia Diagnostics India Pvt. Ltd.
- 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
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.
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