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 Roche Diagnostics and Ortho-Clinical Diagnostics, Inc..
FDA 510(k) Cleared Sars-cov-2 Serology Test Devices (Product Code QVP)
About Product Code QVP - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code QVP since 2023, with 3 receiving FDA clearance (average review time: 311 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QVP have taken an average of 123 days to reach a decision - down from 592 days historically, suggesting improved FDA processing for this classification.
QVP devices are reviewed by the Microbiology panel. Browse all Microbiology devices →