# QLT · Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

_ ·  · Class N_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/MI-misc/QLT

## Overview

- **Product Code:** QLT
- **Device Name:** Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
- **Regulation:** 21 CFR N/A
- **Device Class:** N
- **Review Panel:** [](/submissions/)

## Identification

Multi-analyte nucleic acid-based in vitro diagnostic devices for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that causes COVID-19, and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be used as the sole basis for diagnosis, treatment or other patient management decisions and must be combined with clinical observations, patient history, and/or epidemiological information.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/MI/MI-misc/QLT](https://fda.innolitics.com/submissions/MI/MI-misc/QLT)

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