CDSCO UID IMP/IVD/2022/000152_fca4422f96851b23313febc967325963_3d389941746578050256f051c3db93e1EUROLINE ANA Profile et Mi-2 et Ku
- UID
- IMP/IVD/2022/000152_fca4422f96851b23313febc967325963_3d389941746578050256f051c3db93e1
- Device class
- Class B
- Brand name
- NIL
- License holder
- M/s. CPC Diagnostics Pvt Ltd
- Approving authority
- CDSCO
- Product information
- The EUROLINE test kit provides a qualitative in vitro assay for human autoantibodies of the immunoglobulin class IgG to the 17 different antigens Mi-2, Ku, nRNPSm, Sm, SS-A (NIL), Ro-52, SS-B, Scl-70, PM-Scl100, Jo-1, CENP B, PCNA, dsDNA, nucleosomes, histones, ribosomal P- protein and AMA M2 in serum or plasma for the diagnosis of Sharp syndrome (NIL), lupus erythematosus disseminatus (NIL), Sjogren’s syndrome, progressive systemic sclerosis, poly-/dermatomyositis, overlap syndromes, limited form of progressive systemic sclerosis (NIL) and primary biliary cholangitis
EUROLINE ANA Profile et Mi-2 et Ku is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000152_fca4422f96851b23313febc967325963_3d389941746578050256f051c3db93e1. This device is marketed under the brand name NIL. The license holder is M/s. CPC Diagnostics Pvt Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.
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