Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5870](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5870) → DDL — Thyroglobulin, Rhodamine, Antigen, Antiserum, Control

# DDL · Thyroglobulin, Rhodamine, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5870 · Class 2_

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

## Overview

- **Product Code:** DDL
- **Device Name:** Thyroglobulin, Rhodamine, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5870](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5870)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

## Classification Rationale

Class II (performance standards).

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

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