FDA Product Code QVP: Sars-cov-2 Serology Test
Serological testing for SARS-CoV-2 supports epidemiological surveillance and assessment of past infection. FDA product code QVP covers SARS-CoV-2 serology tests.
These prescription immunoassays detect IgG, IgM, or total antibodies against SARS-CoV-2 antigens in serum or plasma, identifying individuals with prior infection or vaccine response. They are used for seroprevalence studies and to support infection control decisions.
QVP devices are Class II medical devices, regulated under 21 CFR 866.3983 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Ortho-Clinical Diagnostics, Inc. and Roche Diagnostics.
List of Sars-cov-2 Serology Test devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Sars-cov-2 Serology Test devices (product code QVP). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →