Anti-dsDNA IgG - India CDSCO Medical Device Registration

Anti-dsDNA IgG is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_fe1d9c16f28ab11d7dc988149137a277_babce133fcf89a8b17c04cfdf0876074. 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-dsDNA IgG

UID: IMP/IVD/2021/000558_fe1d9c16f28ab11d7dc988149137a277_babce133fcf89a8b17c04cfdf0876074

Brand Name

Anti-Gliadin IgG

License Holder

Sebia Diagnostics India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Anti-dsDNA IgG is an ELISA-based test system for the quantitative measurement of IgG class autoantibodies against double-stranded DNA in human serum or plasma samples. 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, especially systemic lupus erythematosus (Anti-Gliadin IgG). Autoantibodies to dsDNA are diagnostic markers for SLE and levels may be elevated during active disease. Evaluation of a test result should always take into account all clinical and laboratory diagnostic findings

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Anti-dsDNA IgG

M/s Vishat Diagnostic Pvt Ltd.

Anti-dsDNA IgG - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Anti-dsDNA IgG

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ENA-6-Profile

Anti-RNP/Sm

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Anti-Gliadin IgG

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Anti-BPI