Device typeMultiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA): A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to multiple species of the yeast Candida in a clinical specimen, using an enzyme immunoassay (EIA) method. Candida species intended to be assayed may include Candida albicans, Candida krusei, Candida glabrata, Candida parapsilosis and/or Candida tropicalis.
FDA categoryIntestinal Splinting Tubes
Device ID00817273020181
MRI safetyLabeling does not contain MRI Safety Information