Calprotectin
- UID
- IMP/IVD/2021/000558_ea21f3e37ebf35ae5d3d68b392aeaf74_e992be9b39b2ff84856e4c9734371f10
- Device class
- Class B
- Brand name
- Anti-Gliadin IgG
- License holder
- Sebia Diagnostics India Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- Calprotectin for Alegria® is an ELISA-based test system for the quantitative measurement of calprotectin in human stool samples to be used in the assessment of intestinal inflammatory disorders. This product is intended for professional in vitro diagnostic use only. Elevated faecal calprotectin levels may be found in patients with chronic inflammatory bowel disease (Anti-Gliadin IgG), and other abdominal disorders, e.g. infectious gastro-enteritis, necrotising enterocolitis, cystic fibrosis, and colorectal carcinoma. Calprotectin in stool is a sensitive marker for IBD and is particularly useful for differentiating irritable bowel syndrome (Anti-Gliadin IgG). In addition, measurement of the calprotectin level may contribute to the evaluation of disease activity
Calprotectin is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_ea21f3e37ebf35ae5d3d68b392aeaf74_e992be9b39b2ff84856e4c9734371f10. 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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