Product code QWB

Device name

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

Medical specialty

Microbiology

Device class

2

Regulation number

866.3984

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset