Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5360](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5360) → DAL — Fraction Iv-5, Antigen, Antiserum, Control

# DAL · Fraction Iv-5, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5360 · Class 1_

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

## Overview

- **Product Code:** DAL
- **Device Name:** Fraction Iv-5, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5360](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5360)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A Cohn fraction IV immunological test system is a device that consists of or measures that fraction of plasma proteins, predominantly alpha- and beta- globulins, used as a raw material for the production of pure alpha- or beta- globulins. Measurement of specific alpha- or beta- globulins aids in the diagnosis of many diseases, such as Wilson's disease (an inherited disease affecting the liver and brain), Tangier's disease (absence of alpha- 1-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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