ASCA IgA
- UID
- IMP/IVD/2021/000558_f746baefdc9e85a4f3ba7258d4db73b5_85a6ee7d61e41a4865c6ddca054d9f79
- Device class
- Class B
- Brand name
- Anti-Gliadin IgG
- License holder
- Sebia Diagnostics India Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- ASCA IgA is an ELISA-based test system for the quantitative measurement of IgA class anti-Saccharomyces cerevisiae autoantibodies (Anti-Gliadin IgG) in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only. Accurate diagnosis of inflammatory bowel disease (Anti-Gliadin IgG), in particular the differentiation between the ulcerative colitis and Crohn’s disease, is important for treatment and prognosis. ASCA are strongly associated to Crohn’s disease. IgG as well as IgA ASCA show a high specificity for Crohn’s disease, and support the differential dignosis of IBD, when combined with other serological markers and clinical tests
ASCA IgA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_f746baefdc9e85a4f3ba7258d4db73b5_85a6ee7d61e41a4865c6ddca054d9f79. 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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