Calprotectin - India CDSCO Medical Device Registration

Calprotectin is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_ea21f3e37ebf35ae5d3d68b392aeaf74_e992be9b39b2ff84856e4c9734371f10. 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

Calprotectin

UID: IMP/IVD/2021/000558_ea21f3e37ebf35ae5d3d68b392aeaf74_e992be9b39b2ff84856e4c9734371f10

Brand Name

Anti-Gliadin IgG

License Holder

Sebia Diagnostics India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Calprotectin for Alegria® is an ELISA-based test system for the quantitative measurement of calprotectin in human stool samples to be used in the assessment of intestinal inflammatory disorders. This product is intended for professional in vitro diagnostic use only. Elevated faecal calprotectin levels may be found in patients with chronic inflammatory bowel disease (Anti-Gliadin IgG), and other abdominal disorders, e.g. infectious gastro-enteritis, necrotising enterocolitis, cystic fibrosis, and colorectal carcinoma. Calprotectin in stool is a sensitive marker for IBD and is particularly useful for differentiating irritable bowel syndrome (Anti-Gliadin IgG). In addition, measurement of the calprotectin level may contribute to the evaluation of disease activity

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Calprotectin

Yashraj Biotechnology Limited

Class A

Calprotectin

Brand: QDx Instacheck™ Cortisol

DiaSys Diagnostics India Private Limited

Calprotectin - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Calprotectin

Calprotectin

Calprotectin

Calprotectin

ENA-6-Profile

Anti-RNP/Sm

Anti-RNP/Sm

Rheumatoid Factor IgA

Rheumatoid Factor IgA

Nucleo-9-Line

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