← Product Code [DCN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN) · K003419

# RCRP FLEX REAGENT CARTRIDGE (K003419)

_Dade Behring, Inc. · DCN · Feb 14, 2001 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K003419

## Device Facts

- **Applicant:** Dade Behring, Inc.
- **Product Code:** [DCN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN.md)
- **Decision Date:** Feb 14, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5270
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K003419](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K003419)

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