f953cdb7-ba71-4c30-bd0e-eda0d7666332UpdatePublished52023-05-032014-09-16In Commercial DistributionH628372191PrimaryHIBCCAccess Hybritech free PSA QC3721937219008254708Beckman Coulter, Inc.1The Access Hybritech free PSA QC are bi-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of free Prostate Specific Antigen (free PSA) using the Access Immunoassay Systems.falsefalsefalsetruefalsetruetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse54669Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free (unbound) prostate specific antigen (fPSA) in any of the isoforms [i.e., benign PSA (BPSA), inactive/intact PSA, and/or the PSA precursor, proPSA] in a clinical specimen, using a chemiluminescent immunoassay method.falseActiveJJXSingle (Specified) Analyte Controls (Assayed And Unassayed)falsefalse