QFO

Zika Virus Serological Reagents

Product code

QFO

Device name

Zika Virus Serological Reagents

Device class

Class 2

21 CFR

21 CFR 866.3935

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).