OYMClass III

Prostrate Cancer Genes Nucleic Acid Amplification Test System

Unknown

OYM is the FDA product code for Prostrate Cancer Genes Nucleic Acid Amplification Test System, a class III device type. FDA's definition for this code reads: "An in vitro nucleic acid amplification test that measures the concentration of prostate cancer genes". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: OYM
Device name: Prostrate Cancer Genes Nucleic Acid Amplification Test System
FDA definition: An in vitro nucleic acid amplification test that measures the concentration of prostate cancer genes.
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: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OYM.

Recent clearances

Product code OYM

FDA records hold no clearances under product code OYM.

Recent recalls

Product code OYM

FDA records show no recalls under product code OYM.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)