Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5080](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5080) → DFF — Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control

# DFF · Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5080 · Class 2_

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

## Overview

- **Product Code:** DFF
- **Device Name:** Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5080](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5080)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

An alpha -1-antichymotrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques alpha -1-antichymotrypsin (a protein) in serum, other body fluids, and tissues. Alpha -1-antichymotrypsin helps protect tissues against proteolytic (protein-splitting) enzymes released during infection.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K863868](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFF/K863868.md) | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT | Cooper Biomedical, Inc. | Feb 13, 1987 | SESE |

## Top Applicants

- Cooper Biomedical, Inc. — 1 clearance

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

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