ASCA IgA - India CDSCO Medical Device Registration

ASCA IgA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_f746baefdc9e85a4f3ba7258d4db73b5_85a6ee7d61e41a4865c6ddca054d9f79. 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

ASCA IgA

UID: IMP/IVD/2021/000558_f746baefdc9e85a4f3ba7258d4db73b5_85a6ee7d61e41a4865c6ddca054d9f79

Brand Name

Anti-Gliadin IgG

License Holder

Sebia Diagnostics India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

ASCA IgA is an ELISA-based test system for the quantitative measurement of IgA class anti-Saccharomyces cerevisiae autoantibodies (Anti-Gliadin IgG) in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only. Accurate diagnosis of inflammatory bowel disease (Anti-Gliadin IgG), in particular the differentiation between the ulcerative colitis and Crohn’s disease, is important for treatment and prognosis. ASCA are strongly associated to Crohn’s disease. IgG as well as IgA ASCA show a high specificity for Crohn’s disease, and support the differential dignosis of IBD, when combined with other serological markers and clinical tests

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Brand: Anti-Gliadin IgG

Sebia Diagnostics India Pvt. Ltd.

ASCA IgA - 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