Bio-Rad BioPlex 2200 Vasculitis Reagent Pack - HSA Registration DE0503155
Access comprehensive regulatory information for Bio-Rad BioPlex 2200 Vasculitis Reagent Pack in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0503155 and owned by Bio-Rad Laboratories. The device was registered on May 28, 2019.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The BioPlex® 2200 Vasculitis kit is a multiplex flow immunoassay intended for the semi-quantitative detection of IgG autoantibodies to Myeloperoxidase (MPO), Proteinase 3 (PR3) and Glomerular Basement Membrane (GBM) in human serum. In conjunction with clinical findings, the test system is used as an aid in the diagnosis of anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitides: Microscopic Polyangiitis (MPA), Necrotising Glomerulonephritis, Churg-Strauss Syndrome, Wegener’s Granulomatosis and the autoimmune renal disorder, Goodpasture’s syndrome. The BioPlex 2200 Vasculitis kit is intended for use with the Bio-Rad BioPlex 2200 System.