QWB

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

Product code

QWB

Device name

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

Device class

Class 2

21 CFR

21 CFR 866.3984

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-08-07.

1 summaries are archived here for direct download.