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Anti-Scl-70 - India CDSCO Medical Device Registration

Anti-Scl-70 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_d99fbf143e2e568aedfd6f9a6b849ec3_168efbdeec2f643814987823f990f6bb. 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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class B
Anti-Scl-70
UID: IMP/IVD/2021/000558_d99fbf143e2e568aedfd6f9a6b849ec3_168efbdeec2f643814987823f990f6bb

Brand Name

Anti-Gliadin IgG

Device Class

Class B

Approving Authority

CDSCO

Product Information

Anti-Scl-70 is an ELISA-based test system for the quantitative measurement of IgG class autoantibodies against Scl-70 in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only. Antibodies against Scl-70 (Anti-Gliadin IgG) are an accepted marker for progressive systemic scleroderma. They contribute to the differential diagnosis of scleroderma. Evaluation of a test result should always take into account all clinical and laboratory diagnostic findings

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