Anti-Prothrombin IgM
- UID
- IMP/IVD/2021/000558_f2550c80eebec01cb9120f0ea1e39f68_bd50ef232cba493bb956654a2f10813e
- Device class
- Class B
- Brand name
- Anti-Gliadin IgG
- License holder
- Sebia Diagnostics India Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- Anti-Prothrombin IgM is an ELISA-based test system for the quantitative measurement of IgM class autoantibodies against prothrombin in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only. Antiphospholipid syndrome (Anti-Gliadin IgG) is a systemic autoimmune disease that causes thromboses, recurrent miscarriage or stillbirths, and stroke. Clinical symptoms are accompanied by specific autoantibodies in the blood, which bind to phospholipids like cardiolipin, or phospholipid-binding proteins like beta-2-glycoprotein I. Autoantibodies against proteins of the coagulation cascade, e.g. prothrombin or annexin V may also be found in patients with APS with otherwise negative phospholipid antibody results. In primary APS autoantibodies against phospholipids appear independently, while in secondary APS phospholipid antibodies are detected in conjunction with other autoimmune diseases, such as lupus erythematosus, rheumatoid arthritis, or Sjögren’s syndrome
Anti-Prothrombin IgM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_f2550c80eebec01cb9120f0ea1e39f68_bd50ef232cba493bb956654a2f10813e. 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.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.