Calprotectin - India CDSCO Medical Device Registration

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