Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart C — Microbiology Devices](/submissions/MI/subpart-c%E2%80%94microbiology-devices) → [21 CFR 866.2900](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2900) → OID — Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing)

# OID · Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing)

_Microbiology · 21 CFR 866.2900 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/OID

## Overview

- **Product Code:** OID
- **Device Name:** Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing)
- **Regulation:** [21 CFR 866.2900](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2900)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

## Classification Rationale

Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, 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/MI/subpart-c%E2%80%94microbiology-devices/OID](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/OID)

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