ENA-6-Profile
- UID
- IMP/IVD/2021/000558_ffd8b33f69c12662765d250428535aa2_5d72b917bccae0e38df22b6579e6ec10
- Device class
- Class B
- Brand name
- Anti-Gliadin IgG
- License holder
- Sebia Diagnostics India Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- ENA-6-Profile is an ELISA test system for the qualitative measurement of IgG class autoantibodies directed against the extractable nuclear antigens SS-A (Anti-Gliadin IgG), SS-B (Anti-Gliadin IgG), Sm, RNP/Sm, Scl-70, and Jo-1 in human serum or plasma. 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, e.g. systemic lupus erythematosus, mixed connective tissue disease, Sjoegren’s syndrome, scleroderma, and polymyositis/dermatomyositis. Evaluation of a test result should always take into account all clinical and laboratory diagnostic findings
ENA-6-Profile is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_ffd8b33f69c12662765d250428535aa2_5d72b917bccae0e38df22b6579e6ec10. 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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