DeviceClearance

Product code QVP— Microbiology

Elecsys Anti-SARS-CoV-2

Classification name
Sars-Cov-2 Serology Test
Device class
Class 2
Regulation
21 CFR 866.3983
Advisory panel
Microbiology
Total cleared
5
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QVP under 21 CFR 866.3983, via openFDA

Market context for product code QVP

FDA has cleared 5 devices under product code QVP between 2023 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QVP

Recent clearances under product code QVP

Data sourced from openFDA. This site is unofficial and independent of the FDA.