FDA product code OYM: Prostrate Cancer Genes Nucleic Acid Amplification Test System
OYM is the FDA product code for prostrate cancer genes nucleic acid amplification test system. It is a Class III device, reviewed by the Immunology panel. Devices under OYM reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
An in vitro nucleic acid amplification test that measures the concentration of prostate cancer genes.
Classification
| Field | Value |
|---|---|
| Device name | Prostrate Cancer Genes Nucleic Acid Amplification Test System |
| Device class | Class III |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for OYM devices
openFDA lists no recalls for product code OYM.
Frequently asked questions
What is FDA product code OYM?
OYM is the FDA product code for prostrate cancer genes nucleic acid amplification test system. It is a Class III device, reviewed by the Immunology panel.
What device class is OYM?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OYM
- Run a recall and safety report across every OYM manufacturer
- Watch product code OYM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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