Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5820](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5820) → NRX — Complement 4d (C4d) And Complement Receptor 1 (Cr1)

# NRX · Complement 4d (C4d) And Complement Receptor 1 (Cr1)

_Immunology · 21 CFR 866.5820 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NRX

## Overview

- **Product Code:** NRX
- **Device Name:** Complement 4d (C4d) And Complement Receptor 1 (Cr1)
- **Regulation:** [21 CFR 866.5820](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5820)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

A systemic lupus erythematosus (SLE) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum and other body fluids that react with cellular nuclear double-stranded deoxyribonucleic acid (DNA) or other nuclear constituents that are specifically diagnostic of SLE. Measurement of nuclear double-stranded DNA antibodies aids in the diagnosis of SLE (a multisystem autoimmune disease in which tissues are attacked by the person's own antibodies).

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NRX](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NRX)

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