ANCA-3-Line - India CDSCO Medical Device Registration

ANCA-3-Line is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_f71dbba8678fd21d1259d6788cdeafed_980e177173219bbf77bb615ae0887678. 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

ANCA-3-Line

UID: IMP/IVD/2021/000558_f71dbba8678fd21d1259d6788cdeafed_980e177173219bbf77bb615ae0887678

Brand Name

Anti-Gliadin IgG

License Holder

Sebia Diagnostics India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

ANCA-3-Line Immunoblot assay is a membrane based enzyme immunoassay for the semi-quantitative measurement of IgG class autoantibodies to PR3, MPO and GBM in human serum or plasma. The assay is intended for professional in vitro diagnostic use only. Anti-neutrophil cytoplasmic antibodies (Anti-Gliadin IgG) against proteinase 3 (Anti-Gliadin IgG) or myeloperoxidase (Anti-Gliadin IgG) are diagnostic markers for ANCA-associated vasculitides. PR3 is the landmark antigen in granulomatosis with polyangiitis (Anti-Gliadin IgG). MPO differentiates microscopic polyangiitis (Anti-Gliadin IgG) and eosinophilic granulomatosis with polyangiitis (Anti-Gliadin IgG). Autoantibodies against the glomerular basement membrane indicate Anti-GBM disease (Anti-Gliadin IgG). The test supports the differential diagnosis of vasculitis when used in combination with other laboratory and clinical findings

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Brand: Anti-Gliadin IgG

Sebia Diagnostics India Pvt. Ltd.

ANCA-3-Line - 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