Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5430](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5430) → DDN — Beta-2-Glycoprotein I, Antigen, Antiserum, Control

# DDN · Beta-2-Glycoprotein I, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5430 · Class 1_

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

## Overview

- **Product Code:** DDN
- **Device Name:** Beta-2-Glycoprotein I, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5430](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5430)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A beta-2-glycoprotein I immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the beta-2-glycoprotein I (a serum protein) in serum and other body fluids. Measurement of beta-2-glycoprotein I aids in the diagnosis of an inherited deficiency of this serum protein.

## 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 § 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/DDN](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDN)

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