Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5540](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5540) → DAQ — Igg (Fd Fragment Specific), Antigen, Antiserum, Control

# DAQ · Igg (Fd Fragment Specific), Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5540 · Class 1_

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

## Overview

- **Product Code:** DAQ
- **Device Name:** Igg (Fd Fragment Specific), Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5540](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5540)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

An immunoglobulin G (Fd fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the amino terminal (antigen-binding) end (Fd fragment) of the heavy chain (a subunit) of the immunoglobulin antibody molecule in serum. Measurement of immunoglobulin G Fd fragments aids in the diagnosis of plasma antibody-forming cell abnormalities.

## 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K891299](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAQ/K891299.md) | MID-LEVEL IGG KIT CAT. NO. 9315 | Helena Laboratories | Mar 22, 1989 | SESE |

## Top Applicants

- Helena Laboratories — 1 clearance

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

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