Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5130](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5130) → DFB — Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control

# DFB · Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5130 · Class 2_

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

## Overview

- **Product Code:** DFB
- **Device Name:** Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5130](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5130)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

An alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K823829](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFB/K823829.md) | FERRITIN IMMUNORADIOMETRIC ASSAY KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Mar 11, 1983 | SESE |

## Top Applicants

- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance

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

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