FDA product code DIX: Thin Layer Chromatography, Phenobarbital
DIX is the FDA product code for thin layer chromatography, phenobarbital. It is a Class II device, regulated under 21 CFR 862.3660 and reviewed by the Clinical Toxicology panel. Devices under DIX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Thin Layer Chromatography, Phenobarbital |
| Device class | Class II |
| Regulation | 21 CFR 862.3660 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DIX devices
openFDA lists no recalls for product code DIX.
Frequently asked questions
What is FDA product code DIX?
DIX is the FDA product code for thin layer chromatography, phenobarbital. It is a Class II device, regulated under 21 CFR 862.3660 and reviewed by the Clinical Toxicology panel.
What device class is DIX?
Class II, regulation 21 CFR 862.3660. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DIX
- Run a recall and safety report across every DIX manufacturer
- Watch product code DIX 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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