Anti-SS-B - India CDSCO Medical Device Registration

Anti-SS-B is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_daf5771383446641e99729d74fa6422d_44af36ce0a58523087099fa1e6e4bf0d. 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-SS-B

UID: IMP/IVD/2021/000558_daf5771383446641e99729d74fa6422d_44af36ce0a58523087099fa1e6e4bf0d

Brand Name

Anti-Gliadin IgG

License Holder

Sebia Diagnostics India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Anti-SS-B is an ELISA test system for the quantitative measurement of IgG class autoantibodies against SS-B (Anti-Gliadin IgG) in human serum or plasma. This product is intended for professional in vitro diagnostic use only . Antibodies against SS-B are used for the differential diagnosis of systemic inflammatory autoimmune diseases. Autoantibodies against the SS-B protein are usually found together with anti-SS-A in cases of Sjoegren’s syndrome. Evaluation of a test result should always take into account all clinical and laboratory diagnostic findings

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Anti-SS-B

M/s Vishat Diagnostic Pvt Ltd.

Anti-SS-B - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Anti-SS-B

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

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