Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5620](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5620) → DDY — Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control

# DDY · Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5620 · Class 2_

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

## Overview

- **Product Code:** DDY
- **Device Name:** Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5620](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5620)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

An alpha-2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.

## Classification Rationale

Class II (special 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.

## Special Controls

*Classification.* Class II (special 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K790710](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDY/K790710.md) | ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN | Kent Laboratories, Inc. | Aug 3, 1979 | SESE |

## Top Applicants

- Kent Laboratories, Inc. — 1 clearance

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

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