Sars-Cov-2 Serology Test

FDA product code QVP · Class II (moderate risk) · 21 CFR 866.3983 · Microbiology

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.

3510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K252280Elecsys Anti-SARS-CoV-2 SQVP · Traditional Roche Diagnostics04/13/2026SE
K253839Elecsys Anti-SARS-CoV-2QVP · Special Roche Diagnostics12/17/2025SE
K250768Elecsys Anti-SARS-CoV-2QVP · Traditional Roche Diagnostics06/10/2025SE