QRF

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

Product code: QRF
Device name: Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QRF

Classification and pathway per current FDA publications. Data from openFDA (CC0).