FDA product code DLX: Hemagglutination Inhibition, Barbiturate
DLX is the FDA product code for hemagglutination inhibition, barbiturate. It is a Class II device, regulated under 21 CFR 862.3150 and reviewed by the Clinical Toxicology panel. Devices under DLX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Hemagglutination Inhibition, Barbiturate |
| Device class | Class II |
| Regulation | 21 CFR 862.3150 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DLX devices
openFDA lists no recalls for product code DLX.
Frequently asked questions
What is FDA product code DLX?
DLX is the FDA product code for hemagglutination inhibition, barbiturate. It is a Class II device, regulated under 21 CFR 862.3150 and reviewed by the Clinical Toxicology panel.
What device class is DLX?
Class II, regulation 21 CFR 862.3150. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DLX
- Run a recall and safety report across every DLX manufacturer
- Watch product code DLX 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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