Product code QYT

Device name

Over-The-Counter Covid-19 Antigen Test

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

For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.

Source

FDA openFDA device classification dataset