Anti-SS-A
- UID
- IMP/IVD/2021/000558_cdb99da034432140722dbb4a827975d8_a08991c987f9b707041653d0b07e7182
- Device class
- Class B
- Brand name
- Anti-Gliadin IgG
- License holder
- Sebia Diagnostics India Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- Anti-SS-A is an ELISA test system for the quantitative measurement of IgG class autoantibodies against SS-A (Anti-Gliadin IgG) in human serum or plasma. This product is intended for professional in vitro diagnostic use only. This test is useful for the differential diagnosis and monitoring of systemic rheumatic inflammatory autoimmune diseases. Autoantibodies against the two antigens SS-A 52 and SS-A 60 are predominantly found in cases of Sjoegren’s syndrome. Evaluation of a test result should always take into account all clinical and laboratory diagnostic findings
Anti-SS-A is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_cdb99da034432140722dbb4a827975d8_a08991c987f9b707041653d0b07e7182. 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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