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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_fada19a6b05077f5a47abcd8aa058088. 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_fada19a6b05077f5a47abcd8aa058088

Brand Name

Anti-Gliadin IgG

Device Class

Class B

Approving Authority

CDSCO

Product Information

Anti-Cathepsin G is an ELISA test system for the quantitative measurement of IgG class autoantibodies against Cathepsin G in human serum or plasma. 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), Sjoegrenยดs syndrome, and Feltyโ€™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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