Anti-Prothrombin IgM - India CDSCO Medical Device Registration

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.

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CDSCO Registered

Class Class B

Anti-Prothrombin IgM

UID: IMP/IVD/2021/000558_f2550c80eebec01cb9120f0ea1e39f68_bd50ef232cba493bb956654a2f10813e

Brand Name

Anti-Gliadin IgG

License Holder

Sebia Diagnostics India Pvt. Ltd.

Device Class

Class B

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

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Brand: Anti-Gliadin IgG

Sebia Diagnostics India Pvt. Ltd.

Anti-Prothrombin IgM - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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