Product code QFO

Device name

Zika Virus Serological Reagents

Medical specialty

Microbiology

Device class

2

Regulation number

866.3935

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset