Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5270](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5270) → DCH — System, Test, C-Reactive Protein, Rhodamine

# DCH · System, Test, C-Reactive Protein, Rhodamine

_Immunology · 21 CFR 866.5270 · Class 2_

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

## Overview

- **Product Code:** DCH
- **Device Name:** System, Test, C-Reactive Protein, Rhodamine
- **Regulation:** [21 CFR 866.5270](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5270)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K964687](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCH/K964687.md) | N LATEX CRP MONO REAGENT | Behring Diagnostics, Inc. | Dec 16, 1996 | SESE |

## Top Applicants

- Behring Diagnostics, Inc. — 1 clearance

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

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