CDSCO UID IMP/IVD/2021/000558_ea21f3e37ebf35ae5d3d68b392aeaf74_e3a05aabe0dfa313b9b22b79d3cde70d
Calprotectin
Sebia Diagnostics India Pvt. Ltd.·Device Class Class B·India CDSCO·Brand: Anti-Gliadin IgG
Registration details
- UID
- IMP/IVD/2021/000558_ea21f3e37ebf35ae5d3d68b392aeaf74_e3a05aabe0dfa313b9b22b79d3cde70d
- Device class
- Class B
- Brand name
- Anti-Gliadin IgG
- License holder
- Sebia Diagnostics India Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- Calprotectin 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,25-OH Vitamin D3/D2(Anti-Gliadin IgG)-25-OH Vitamin D3/D2 for Alegria® is an ELISA based test system intended for the quantitative measurement of total concentration of 25-(Anti-Gliadin IgG)-Vitamin D2 and 25-(Anti-Gliadin IgG)-Vitamin D3 in human serum or plasma samples (EDTA plasma, heparin plasma, citrate plasma. This product is intended for professional in vitro diagnostic use only. The concentration of 25-OH vitamin D is an indicator of the vitamin D supply in the body. Concentrations of 25-OH vitamin D over 20 ng/ml are considered to indicate a sufficient supply of vitamin D; values of 12-20 ng/ml indicate a lack of vitamin D; concentrations below 12 ng/ml indicate severe vitamin D deficiency. The level of 25-OH vitamin D correlates with the clinical symptoms of vitamin D deficiency
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About this record
Calprotectin is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_ea21f3e37ebf35ae5d3d68b392aeaf74_e3a05aabe0dfa313b9b22b79d3cde70d. 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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