ENA-6-Profile - India CDSCO Medical Device Registration

ENA-6-Profile is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_ffd8b33f69c12662765d250428535aa2_5d72b917bccae0e38df22b6579e6ec10. 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

ENA-6-Profile

UID: IMP/IVD/2021/000558_ffd8b33f69c12662765d250428535aa2_5d72b917bccae0e38df22b6579e6ec10

Brand Name

Anti-Gliadin IgG

License Holder

Sebia Diagnostics India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

ENA-6-Profile is an ELISA test system for the qualitative measurement of IgG class autoantibodies directed against the extractable nuclear antigens SS-A (Anti-Gliadin IgG), SS-B (Anti-Gliadin IgG), Sm, RNP/Sm, Scl-70, and Jo-1 in human serum or plasma. This product is intended for professional in vitro diagnostic use only. The test is used as an aid in the differential diagnosis of inflammatory autoimmune diseases, e.g. systemic lupus erythematosus, mixed connective tissue disease, Sjoegren’s syndrome, scleroderma, and polymyositis/dermatomyositis. Evaluation of a test result should always take into account all clinical and laboratory diagnostic findings

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Anti-RNP/Sm

Brand: Anti-Gliadin IgG

Sebia Diagnostics India Pvt. Ltd.

ENA-6-Profile - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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

Anti-BPI

CAPIprotect

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