Anti-dsDNA IgG
- UID
- IMP/IVD/2021/000558_fe1d9c16f28ab11d7dc988149137a277_babce133fcf89a8b17c04cfdf0876074
- Device class
- Class B
- Brand name
- Anti-Gliadin IgG
- License holder
- Sebia Diagnostics India Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- Anti-dsDNA IgG is an ELISA-based test system for the quantitative measurement of IgG class autoantibodies against double-stranded DNA in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only. The test is used as an aid in the differential diagnosis of inflammatory autoimmune diseases, especially systemic lupus erythematosus (Anti-Gliadin IgG). Autoantibodies to dsDNA are diagnostic markers for SLE and levels may be elevated during active disease. Evaluation of a test result should always take into account all clinical and laboratory diagnostic findings
Anti-dsDNA IgG is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_fe1d9c16f28ab11d7dc988149137a277_babce133fcf89a8b17c04cfdf0876074. 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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