FDA product code · Immunology

Complement 4d (C4d) And Complement Receptor 1 (Cr1)

Name: FDA decisions, review times, recalls and adverse event reports for product code NRX
Creator: 510(k) Report

NRXClass II21 CFR 866.5820510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, immunology panel

Twenty years of NRX at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — NRX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NRX? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 866.5820.

DHC System, Test, Systemic Lupus Erythematosus