# Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
> **Product code: QWB** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3984
## Classification
- **FDA Product Code:** QWB
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3984
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

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.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QWB)
---
*AI Analytics · CC0 1.0*