Device typeMultiple candida species antigen IVD, kit, rapid agglutination, clinical: A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple species of the yeast Candida (e.g., Candida albicans, Candida tropicalis and/or Candida parapsilosis) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid agglutination method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
FDA categoryANTIGEN, ID, CANDIDA ALBICANS
Device ID78600000686023
Catalog numberCO3/7
MRI safetyLabeling does not contain MRI Safety Information