PYS

Zika Virus Serological Reagents (Emergency Use)

Product code

PYS

Device name

Zika Virus Serological Reagents (Emergency Use)

Device class

Class N

Medical specialty

Unknown

Marketing pathway

EUA - Emergency Use Authorization

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).