← Product Code [DCK](/productcode/DCK) · K882998

# ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST (K882998)

_Amtec Diagnostics International, Inc. · DCK · Sep 7, 1988 · Immunology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K882998

## Device Facts

- **Applicant:** Amtec Diagnostics International, Inc.
- **Product Code:** [DCK](/productcode/DCK.md)
- **Decision Date:** Sep 7, 1988
- **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-staging.innolitics.com/device/K882998](https://fda-staging.innolitics.com/device/K882998)

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