# QLW · Covid-19 Test Home Collection Kit Devices

_ ·  · Class N_

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

## Overview

- **Product Code:** QLW
- **Device Name:** Covid-19 Test Home Collection Kit Devices
- **Regulation:** 21 CFR N/A
- **Device Class:** N
- **Review Panel:** [](/submissions/)

## Identification

Specimens collected using the Home Collection Kit can be transported at ambient temperature for testing at a laboratory. SARS-CoV-2 RNA from the clinical specimen is maintained in the specimen packaging and suitable for use in diagnostic testing preformed using a molecular in vitro diagnostic (IVD) test for the detection of SARS-CoV-2 RNA that is authorized for use with the COVID-19 Test Home Collection Kit.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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