QVPClass II

Sars-Cov-2 Serology Test

21 CFR 866.3983 / Microbiology

QVP is the FDA product code for Sars-Cov-2 Serology Test, a class II device type, regulated under 21 CFR 866.3983. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 5 510(k) clearances under this code, the most recent dated 2026-04-13, and no recalls.

Classification record

Product code: QVP
Device name: Sars-Cov-2 Serology Test
FDA 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.
Regulation: 21 CFR 866.3983
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 5
Ingested recalls: 0

Clearances, product code QVP

By decision year

5 clearances under product code QVP with a decision year between 2023 and 2026, 2023 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code QVP by decision year
Year	Clearances
2023	2
2025	2
2026	1

Applicants with the most clearances

Product code QVP

Applicants holding the most 510(k) clearances under product code QVP
Applicant	Clearances
Roche Diagnostics GmbH	3
Ortho-Clinical Diagnostics, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code QVP

Recent recalls

Product code QVP

FDA records show no recalls under product code QVP.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)