Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
Medical specialty
Unknown
Device class
3
Review panel
IM
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Test system that combines values from multiple assays with/without other patient information to yield a score value for aid in detection of prostate cancer and/or decision for prostate biopsy.