FDA product code OQS: Laboratory Developed Test
OQS is the FDA product code for laboratory developed test. It is a Not classified device, reviewed by the Pathology panel. Devices under OQS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Laboratory Developed Test
Classification
| Field | Value |
|---|---|
| Device name | Laboratory Developed Test |
| Device class | Not classified |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Recalls for OQS devices
openFDA lists no recalls for product code OQS.
Frequently asked questions
What is FDA product code OQS?
OQS is the FDA product code for laboratory developed test. It is a Not classified device, reviewed by the Pathology panel.
What device class is OQS?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OQS
- Run a recall and safety report across every OQS manufacturer
- Watch product code OQS 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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