FDA product code QYD: Adalimumab Assay
QYD is the FDA product code for adalimumab assay. It is a Class II device, regulated under 21 CFR 862.3115 and reviewed by the Clinical Toxicology panel. Devices under QYD reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
An in vitro diagnostic device intended for the measurement of adalimumab, an anti-tumor necrosis factor alpha monoclonal antibody
Classification
| Field | Value |
|---|---|
| Device name | Adalimumab Assay |
| Device class | Class II |
| Regulation | 21 CFR 862.3115 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
Recalls for QYD devices
openFDA lists no recalls for product code QYD.
Frequently asked questions
What is FDA product code QYD?
QYD is the FDA product code for adalimumab assay. It is a Class II device, regulated under 21 CFR 862.3115 and reviewed by the Clinical Toxicology panel.
What device class is QYD?
Class II, regulation 21 CFR 862.3115. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QYD
- Run a recall and safety report across every QYD manufacturer
- Watch product code QYD 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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