Anti-Scl-70
- UID
- IMP/IVD/2021/000558_d99fbf143e2e568aedfd6f9a6b849ec3_168efbdeec2f643814987823f990f6bb
- Device class
- Class B
- Brand name
- Anti-Gliadin IgG
- License holder
- Sebia Diagnostics India Pvt. Ltd.
- 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
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.
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