Anti-RNP/Sm - India CDSCO Medical Device Registration

Anti-RNP/Sm is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_ffcf1d825045cd6e6301a060b2794599_1b202c911b3220c1275866d02a918f9d. 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-RNP/Sm

UID: IMP/IVD/2021/000558_ffcf1d825045cd6e6301a060b2794599_1b202c911b3220c1275866d02a918f9d

Brand Name

Anti-Gliadin IgG

License Holder

Sebia Diagnostics India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Anti-RNP/Sm is an ELISA test system for the quantitative measurement of IgG class autoantibodies against RNP/Sm in human serum or plasma. This product is intended for professional in vitro diagnostic use only. Antibodies against the RNP/Sm complex are useful in the diagnosis of mixed connective tissue disorder (Anti-Gliadin IgG) and related autoimmune diseases. Antibodies against the 70 kDa protein of this complex are a very specific marker for Sharp syndrome. The Sm proteins are recognised by antibodies that may occur in cases of mixed connective tissue disorder and systemic lupus erythematosus. Evaluation of a test result should always take into account all clinical and laboratory diagnostic findings

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Brand: Anti-Gliadin IgG

Sebia Diagnostics India Pvt. Ltd.

Anti-RNP/Sm - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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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

ENA-6-Profile

Anti-RNP/Sm

Rheumatoid Factor IgA

Rheumatoid Factor IgA

Nucleo-9-Line

Anti-dsDNA IgG

Anti-Gliadin IgG

Anti-Gliadin IgG

Anti-BPI