QFOClass II

Zika Virus Serological Reagents

21 CFR 866.3935 / Microbiology

QFO is the FDA product code for Zika Virus Serological Reagents, a class II device type, regulated under 21 CFR 866.3935. FDA's definition for this code reads: "Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical...". As of 2026-09-10, FDA records hold 4 510(k) clearances under this code, the most recent dated 2020-06-03, and no recalls.

Classification record

Product code: QFO
Device name: Zika Virus Serological Reagents
FDA definition: Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical diagnosis of Zika virus infection in conjunction with other clinical and laboratory findings.
Regulation: 21 CFR 866.3935
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: 4
Ingested recalls: 0

Clearances, product code QFO

By decision year

4 clearances under product code QFO with a decision year between 2019 and 2020, 2019 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code QFO by decision year
Year	Clearances
2019	3
2020	1

Applicants with the most clearances

Product code QFO

Applicants holding the most 510(k) clearances under product code QFO
Applicant	Clearances
Chembio Diagnostic Systems, Inc.	1
Diasorin Inc.	1
Inbios International, Inc.	1
Siemens Healthcare Diagnostics Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code QFO

Recent recalls

Product code QFO

FDA records show no recalls under product code QFO.

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)