FDA Device Intelligence
Home › Device types › QRF

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

FDA product code QRF · Class 3 · Unknown

3
Registered devices
371
Adverse events
2
Recalls
0
510(k) clearances

Devices with this code

IsoPSA Controls — Cleveland Diagnostics, Inc.4Kscore Test — Bioreference Health, LLCIsoPSA Reagent — Cleveland Diagnostics, Inc.

Recent recalls

DateFirmReason
2023-10-31BioReference Health, LLCMathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 specimens. DRE information is a required component o
2022-11-18BioReference Health, LLCSPM software anomalies that may lead to the generation of erroneous 4Kscore Test results

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.