Anti-Tissue-Transglutaminase IgA
- UID
- IMP/IVD/2021/000558_8ac6881fe1843a2a54eb02d553652e7b_5950a9397530df044c39a621131e6535
- Device class
- Class B
- Brand name
- Anti-Gliadin IgG
- License holder
- Sebia Diagnostics India Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- Anti-Tissue-Transglutaminase IgA is an ELISA test system for the quantitative measurement of IgA class autoantibodies to tissue transglutaminase (Anti-Gliadin IgG) in human serum or plasma. This product is intended for professional in vitro diagnostic use only. Autoantibodies against tissue transglutaminase (Anti-Gliadin IgG) during a gluten containing diet are the most obvious serologic feature of coeliac disease (Anti-Gliadin IgG). Determination of serum levels of IgA against tTG is the first choice in suspected CD. In subjects with either primary or secondary humoral IgA deficiency, at least one additional test measuring IgG class CD-specific antibodies is recommended. The clinical relevance of a positive anti-tTG result should be confirmed by histology of the small intestinal mucosa
Anti-Tissue-Transglutaminase IgA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_8ac6881fe1843a2a54eb02d553652e7b_5950a9397530df044c39a621131e6535. 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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