Nucleo-9-Line - India CDSCO Medical Device Registration

Nucleo-9-Line is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_fe93423b36c4c81fb4114c4d9cbc45ff_1e3ac89db80d6f55d48da4e4dcea9e6f. 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

Nucleo-9-Line

UID: IMP/IVD/2021/000558_fe93423b36c4c81fb4114c4d9cbc45ff_1e3ac89db80d6f55d48da4e4dcea9e6f

Brand Name

Anti-Gliadin IgG

License Holder

Sebia Diagnostics India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Nucleo-9-Line Immunoblot assay is a membrane based enzyme immunoassay for the semi-quantitative measurement of IgG class autoantibodies to dsDNA, nucleosomes, SS-A (Anti-Gliadin IgG), SS-B, Sm, RNP/Sm, Scl -70, Jo-1 and centromere B in human serum or plasma. The assay 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. Evaluation of a test result should always take into account all clinical and laboratory diagnostic findings

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ENA-6-Profile

Brand: Anti-Gliadin IgG

Sebia Diagnostics India Pvt. Ltd.

Nucleo-9-Line - 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

Anti-dsDNA IgG

Anti-Gliadin IgG

Anti-Gliadin IgG

Anti-BPI

Anti-BPI

CAPIprotect

ENA-6-Profile

Anti-RNP/Sm

Anti-RNP/Sm

Rheumatoid Factor IgA

Rheumatoid Factor IgA

Anti-dsDNA IgG

Anti-Gliadin IgG

Anti-Gliadin IgG

Anti-BPI