510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QRFClass III

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

Unknown
FDA source (opens on fda.gov)

QRF is the FDA product code for Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer, a class III device type. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and 2 recalls.

Classification record

Product code
QRF
Device name
Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
2

Companies listing this code with FDA

Companies whose registered establishments list this code