Rheumatoid Factor IgM - India CDSCO Medical Device Registration

Rheumatoid Factor IgM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_f44fda19e10bd77e16962358502a0e82_7ba219aab9c0f7206003c5cdcaab4edb. 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

Rheumatoid Factor IgM

UID: IMP/IVD/2021/000558_f44fda19e10bd77e16962358502a0e82_7ba219aab9c0f7206003c5cdcaab4edb

Brand Name

Anti-Gliadin IgG

License Holder

Sebia Diagnostics India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Rheumatoid Factor IgM is an ELISA-based test system for the quantitative measurement of IgM 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

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Brand: Anti-Gliadin IgG

Sebia Diagnostics India Pvt. Ltd.

Rheumatoid Factor IgM - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

ENA-6-Profile

Anti-RNP/Sm

Anti-RNP/Sm

Rheumatoid Factor IgA

Rheumatoid Factor IgA

Nucleo-9-Line

Anti-dsDNA IgG

Anti-Gliadin IgG

Anti-Gliadin IgG

Anti-BPI

CAPIprotect

ENA-6-Profile

Anti-RNP/Sm

Anti-RNP/Sm

Rheumatoid Factor IgA

Rheumatoid Factor IgA

Nucleo-9-Line

Anti-dsDNA IgG

Anti-Gliadin IgG

Anti-Gliadin IgG