Nucleo-9-Line
- UID
- IMP/IVD/2021/000558_fe93423b36c4c81fb4114c4d9cbc45ff_1e3ac89db80d6f55d48da4e4dcea9e6f
- Device class
- Class B
- Brand name
- Anti-Gliadin IgG
- License holder
- Sebia Diagnostics India Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- Nucleo-9-Line Immunoblot assay is a membrane based enzyme immunoassay for the semi-quantitative measurement of IgG class autoantibodies to dsDNA, nucleosomes, SS-A (Anti-Gliadin IgG), SS-B, Sm, RNP/Sm, Scl -70, Jo-1 and centromere B in human serum or plasma. The assay is intended for professional in vitro diagnostic use only. The test is used as an aid in the differential diagnosis of inflammatory autoimmune diseases, e.g. systemic lupus erythematosus, mixed connective tissue disease, Sjoegren’s syndrome, scleroderma. Evaluation of a test result should always take into account all clinical and laboratory diagnostic findings
Nucleo-9-Line is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000558_fe93423b36c4c81fb4114c4d9cbc45ff_1e3ac89db80d6f55d48da4e4dcea9e6f. 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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