QVP

Sars-Cov-2 Serology Test

Product code

QVP

Device name

Sars-Cov-2 Serology Test

Device class

Class 2

21 CFR

21 CFR 866.3983

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

3

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification 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.

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

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

Last three years. Most recent: 2026-04-13.

3 summaries are archived here for direct download.