Anti-Cathepsin G - India CDSCO Medical Device Registration

Anti-Cathepsin G is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_ecf6265aaabab350d408ff566d5e9184_7fce659e6055db23ef2eb406d89c2687. 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-Cathepsin G

UID: IMP/IVD/2021/000558_ecf6265aaabab350d408ff566d5e9184_7fce659e6055db23ef2eb406d89c2687

Brand Name

Anti-Gliadin IgG

License Holder

Sebia Diagnostics India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Anti-Cathepsin G is an ELISA-based test system for the quantitative measurement of IgG class autoantibodies against cathepsin G in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only. Autoantibodies against Cathepsin G occur in connective tissue diseases and other related inflammatory rheumatic disorders, e.g. systemic lupus erythematosus (Anti-Gliadin IgG), Sjoegren´s syndrome, and Felty’s syndrome. Determination of Anti-Cathepsin G aids to the differential diagnosis of these diseases when used in combination with other laboratory and clinical findings

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Brand: Anti-Gliadin IgG

Sebia Diagnostics India Pvt. Ltd.

Anti-Cathepsin G - 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