84ddb56f-004d-4f3b-9fb8-011518d5bcfeUpdatePublished52026-02-092016-09-24In Commercial DistributionM7498263RO1PrimaryHIBCCHEp-2000® IgG Fluorescent ANA-Ro Test System8263-Ro8263-Ro038271904IMMUNO CONCEPTS INC1Custom - HEp-2000® IgG FA w/cs ANA-Ro BP - 6300 wellsfalsefalsefalsetruefalsetruetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety Informationfalsefalse54808Multiple antinuclear antibody (ANA) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection for multiple types of antinuclear antibodies (ANA) in a clinical specimen, using a fluorescent immunoassay method.falseActivefalsefalse