Product code QVP

Device name

Sars-Cov-2 Serology Test

Medical specialty

Microbiology

Device class

2

Regulation number

866.3983

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

A SARS-CoV-2 serology test is a prescription in vitro diagnostic device for the detection of specific binding antibodies to SARS-CoV-2 in clinical specimens. The detection of SARS-CoV-2 antibodies is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test is not intended for the diagnosis of acute SARS-CoV-2 infection, nor screening blood, plasma, cells, or tissue donors.

Source

FDA openFDA device classification dataset