Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5800](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5800) → DFX — Sperm, Fitc, Antigen, Antiserum, Control

# DFX · Sperm, Fitc, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5800 · Class 1_

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

## Overview

- **Product Code:** DFX
- **Device Name:** Sperm, Fitc, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5800](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5800)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A seminal fluid (sperm) immunological test system is a device that consists of the reagents used for legal purposes to identify and differentiate animal and human semen. The test results may be used as court evidence in alleged instances of rape and other sex-related crimes.

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

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