Rheumatoid Factor IgA
- UID
- IMP/IVD/2021/000558_ff52f65da482dc3811a51d722e8b82cb_5cc73e194f06f76a783912058c5cd9d4
- Device class
- Class B
- Brand name
- Anti-Gliadin IgG
- License holder
- Sebia Diagnostics India Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- Rheumatoid Factor IgA is an ELISA test system for the quantitative measurement of IgA class rheumatoid factor 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 rheumatoid arthritis (Anti-Gliadin IgG), and presence of rheumatoid factors (Anti-Gliadin IgG) is an integral part of the current ACR criteria for classification of RA. In established RA, high titres of serum IgG and especially IgM RF indicate poor prognosis. The presence of either IgG or IgA RF in patients with long-standing RA may be a prognostic indicator of systemic manifestations. Evaluation of a test result should always take into account all clinical and laboratory findings
Rheumatoid Factor IgA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_ff52f65da482dc3811a51d722e8b82cb_5cc73e194f06f76a783912058c5cd9d4. 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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