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Access Hybritech p2PSA Calibrators
The Access Hybritech p2PSA Calibrators are intended to calibrate the Access Hybritech p2PSA assay as an aid in distinguishing prostate cancer from benign prostatic conditions using human serum on the Access Immunoassay Systems.
Details
Device typeFree (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay: A 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.
FDA categoryP2psa
Device IDH628B037051
Catalog numberB03705
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information