FDA product code NHS: Assay, Genotype, Hiv Drug Resistance, In Vitro
NHS is the FDA product code for assay, genotype, hiv drug resistance, in vitro. It is a Class II device, regulated under 21 CFR 866.3950 and reviewed by the Immunology panel. Devices under NHS reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Hiv-1 drug resistance genotyping
Classification
| Field | Value |
|---|---|
| Device name | Assay, Genotype, Hiv Drug Resistance, In Vitro |
| Device class | Class II |
| Regulation | 21 CFR 866.3950 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
Recalls for NHS devices
openFDA lists no recalls for product code NHS.
Frequently asked questions
What is FDA product code NHS?
NHS is the FDA product code for assay, genotype, hiv drug resistance, in vitro. It is a Class II device, regulated under 21 CFR 866.3950 and reviewed by the Immunology panel.
What device class is NHS?
Class II, regulation 21 CFR 866.3950. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NHS
- Run a recall and safety report across every NHS manufacturer
- Watch product code NHS 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.