Anti-Tissue-Transglutaminase IgA - India CDSCO Medical Device Registration

Anti-Tissue-Transglutaminase IgA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_8ac6881fe1843a2a54eb02d553652e7b_5950a9397530df044c39a621131e6535. 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-Tissue-Transglutaminase IgA

UID: IMP/IVD/2021/000558_8ac6881fe1843a2a54eb02d553652e7b_5950a9397530df044c39a621131e6535

Brand Name

Anti-Gliadin IgG

License Holder

Sebia Diagnostics India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Anti-Tissue-Transglutaminase IgA is an ELISA test system for the quantitative measurement of IgA class autoantibodies to tissue transglutaminase (Anti-Gliadin IgG) in human serum or plasma. This product is intended for professional in vitro diagnostic use only. Autoantibodies against tissue transglutaminase (Anti-Gliadin IgG) during a gluten containing diet are the most obvious serologic feature of coeliac disease (Anti-Gliadin IgG). Determination of serum levels of IgA against tTG is the first choice in suspected CD. In subjects with either primary or secondary humoral IgA deficiency, at least one additional test measuring IgG class CD-specific antibodies is recommended. The clinical relevance of a positive anti-tTG result should be confirmed by histology of the small intestinal mucosa

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Anti-Tissue-Transglutaminase IgA

M/s Vishat Diagnostic Pvt Ltd.

Anti-Tissue-Transglutaminase IgA - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Anti-Tissue-Transglutaminase IgA

ENA-6-Profile

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ENA-6-Profile

Anti-RNP/Sm

Anti-RNP/Sm

Rheumatoid Factor IgA

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Nucleo-9-Line

Anti-dsDNA IgG

Anti-Gliadin IgG

Anti-Gliadin IgG