Anti-SS-A - India CDSCO Medical Device Registration

Anti-SS-A is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_cdb99da034432140722dbb4a827975d8_a08991c987f9b707041653d0b07e7182. 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-A

UID: IMP/IVD/2021/000558_cdb99da034432140722dbb4a827975d8_a08991c987f9b707041653d0b07e7182

Brand Name

Anti-Gliadin IgG

License Holder

Sebia Diagnostics India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Anti-SS-A is an ELISA test system for the quantitative measurement of IgG class autoantibodies against SS-A (Anti-Gliadin IgG) in human serum or plasma. This product is intended for professional in vitro diagnostic use only. This test is useful for the differential diagnosis and monitoring of systemic rheumatic inflammatory autoimmune diseases. Autoantibodies against the two antigens SS-A 52 and SS-A 60 are predominantly found 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-A

M/s Vishat Diagnostic Pvt Ltd.

Anti-SS-A - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Anti-SS-A

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