# PYS · Zika Virus Serological Reagents (Emergency Use)

_ ·  · Class N_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/MI-misc/PYS

## Overview

- **Product Code:** PYS
- **Device Name:** Zika Virus Serological Reagents (Emergency Use)
- **Regulation:** 21 CFR N/A
- **Device Class:** N
- **Review Panel:** [](/submissions/)

## Identification

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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/MI/MI-misc/PYS](https://fda.innolitics.com/submissions/MI/MI-misc/PYS)

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