Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5775](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5775) → NPH — Antigen, Cartilage Oligomeric Matrix Protein (Comp)

# NPH · Antigen, Cartilage Oligomeric Matrix Protein (Comp)

_Immunology · 21 CFR 866.5775 · Class 2_

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

## Overview

- **Product Code:** NPH
- **Device Name:** Antigen, Cartilage Oligomeric Matrix Protein (Comp)
- **Regulation:** [21 CFR 866.5775](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5775)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## 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.

## 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/NPH](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NPH)

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