Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5510](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5510) → OPY — Igal Heavy & Light Chain Combined

# OPY · Igal Heavy & Light Chain Combined

_Immunology · 21 CFR 866.5510 · Class 2_

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

## Overview

- **Product Code:** OPY
- **Device Name:** Igal Heavy & Light Chain Combined
- **Regulation:** [21 CFR 866.5510](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5510)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

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

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