Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3984](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3984) → QWB — Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

# QWB · Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

_Microbiology · 21 CFR 866.3984 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QWB

## Overview

- **Product Code:** QWB
- **Device Name:** Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
- **Regulation:** [21 CFR 866.3984](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3984)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

An over-the-counter molecular test to detect SARS-CoV-2 is an in vitro diagnostic device for the detection of SARS-CoV-2 in clinical specimens to aid in the diagnosis of SARS-CoV-2 infection. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K232643](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QWB/K232643.md) | Cue COVID-19 Molecular Test | Cue Health, Inc. | Nov 28, 2023 | SESE |
| [DEN220028](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QWB/DEN220028.md) | Cue COVID-19 Molecular Test | Cue Health, Inc. | Jun 6, 2023 | DENG |

## Top Applicants

- Cue Health, Inc. — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QWB](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QWB)

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