Anti-RNP/Sm
- UID
- IMP/IVD/2021/000558_ffcf1d825045cd6e6301a060b2794599_1b202c911b3220c1275866d02a918f9d
- Device class
- Class B
- Brand name
- Anti-Gliadin IgG
- License holder
- Sebia Diagnostics India Pvt. Ltd.
- 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
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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