Device typeMultiple liver fibrosis marker IVD, kit, chemiluminescent immunoassay: A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antigens or markers associated with liver fibrosis in a clinical specimen, using a chemiluminescent immunoassay method. The range of analytes detected may include, but is not limited to, hyaluronic acid (HA), procollagen type III N-terminal propeptide (PIIINP), tissue inhibitor of matrix metalloproteinase 1 (TIMP-1).
FDA categoryPrognostic test for assessment of liver related disease progression
Device ID00630414618128
Catalog number11207300
MRI safetyLabeling does not contain MRI Safety Information