← Product Code [LIO](/submissions/MI/subpart-c%E2%80%94microbiology-devices/LIO) · K953929

# MID-STREAM COLLECTION SET-STERILE (K953929)

_Trinity Laboratories, Inc. · LIO · Nov 16, 1995 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/LIO/K953929

## Device Facts

- **Applicant:** Trinity Laboratories, Inc.
- **Product Code:** [LIO](/submissions/MI/subpart-c%E2%80%94microbiology-devices/LIO.md)
- **Decision Date:** Nov 16, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.2900
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/LIO/K953929](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/LIO/K953929)

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