The United States (US) Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to authorize the use of the Zika ELITe MGB® Kit U.S. for the in vitro qualitative detection of Zika virus with specified instruments. This assay tests for Zika virus RNA in human serum and EDTA plasma.

The United States (US) Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to authorize the use of the Zika ELITe MGB® Kit U.S. for the in vitro qualitative detection of Zika virus with specified instruments. This assay tests for Zika virus RNA in human serum and EDTA plasma.
Zika ELITe MGB® - EUA - M800552

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Zika virus in a clinical specimen, using a nucleic acid technique (NAT).

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Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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Device Id: 03661540950018

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A