FDA product code OYB: Kit, Rna Detection, Human Papillomavirus
OYB is the FDA product code for kit, rna detection, human papillomavirus. It is a Class III device, reviewed by the Microbiology panel. Devices under OYB reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 1 recall for OYB devices, 1 initiated in the last five years.
Definition
For the detection of human papillomavirus RNA to aid in assessing risk of cancer.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Rna Detection, Human Papillomavirus |
| Device class | Class III |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for OYB devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-02-18.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code OYB?
OYB is the FDA product code for kit, rna detection, human papillomavirus. It is a Class III device, reviewed by the Microbiology panel.
What device class is OYB?
Class III. Typical premarket route: PMA.
Have OYB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2026-02-18.
Next steps
- Run an FDA pathway report with predicate devices for product code OYB
- Run a recall and safety report across every OYB manufacturer
- Watch product code OYB 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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