Product code QKO

Device name

Reagent, Coronavirus Serological

Medical specialty

Unknown

Device class

N

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

The qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens.

Source

FDA openFDA device classification dataset