FDA product code PUJ: Voriconazole Test System
PUJ is the FDA product code for voriconazole test system. It is a Class II device, regulated under 21 CFR 862.3970 and reviewed by the Clinical Toxicology panel. Devices under PUJ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A voriconazole test system is a device intended to measure voriconazole in human serum. Measurements obtained by this device are used in monitoring levels of voriconazole to ensure appropriate therapy.
Classification
| Field | Value |
|---|---|
| Device name | Voriconazole Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.3970 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
Recalls for PUJ devices
openFDA lists no recalls for product code PUJ.
Frequently asked questions
What is FDA product code PUJ?
PUJ is the FDA product code for voriconazole test system. It is a Class II device, regulated under 21 CFR 862.3970 and reviewed by the Clinical Toxicology panel.
What device class is PUJ?
Class II, regulation 21 CFR 862.3970. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PUJ
- Run a recall and safety report across every PUJ manufacturer
- Watch product code PUJ 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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