← Product Code [DHR](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHR) · K002609

# TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM (K002609)

_Roche Diagnostics Corp. · DHR · Sep 5, 2000 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHR/K002609

## Device Facts

- **Applicant:** Roche Diagnostics Corp.
- **Product Code:** [DHR](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHR.md)
- **Decision Date:** Sep 5, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5775
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHR/K002609](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHR/K002609)

**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