← Product Code [DHC](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC) · K800992

# CORDIA NP (K800992)

_Cordis Corp. · DHC · May 8, 1980 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K800992

## Device Facts

- **Applicant:** Cordis Corp.
- **Product Code:** [DHC](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC.md)
- **Decision Date:** May 8, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5820
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory 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).

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K800992](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K800992)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com