FDA product code NRX: Complement 4d (C4d) And Complement Receptor 1 (Cr1)
NRX is the FDA product code for complement 4d (c4d) and complement receptor 1 (cr1). It is a Class II device, regulated under 21 CFR 866.5820 and reviewed by the Immunology panel. Devices under NRX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
The device is an indirect immunofluorescence assay utilizing monoclonal antibodies and flow cytometry in the quantitative determination of complement 4d (C4d) and complement receptor 1 (CR1) on the surface of erythrocytes from EDTA anti-coagulated whole blood. The C4d and CR1 results are used in a ratio as an aid in the diagnosis of systemic lupus erythematosus.
Classification
| Field | Value |
|---|---|
| Device name | Complement 4d (C4d) And Complement Receptor 1 (Cr1) |
| Device class | Class II |
| Regulation | 21 CFR 866.5820 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NRX devices
openFDA lists no recalls for product code NRX.
Frequently asked questions
What is FDA product code NRX?
NRX is the FDA product code for complement 4d (c4d) and complement receptor 1 (cr1). It is a Class II device, regulated under 21 CFR 866.5820 and reviewed by the Immunology panel.
What device class is NRX?
Class II, regulation 21 CFR 866.5820. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NRX
- Run a recall and safety report across every NRX manufacturer
- Watch product code NRX 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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