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(As of March 15, 2017)

FDA EUAs for Zika Tests
(As of March 15, 2017)

by Glenn S. Demby | Mar 31, 2017

Date Issued Test Company Feb. 26, 2016* CDC Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay Zika MAC-ELISA March 17, 2016* CDC Trioplex Real-time RT-PCR Assay Trioplex rRT-PCR April 28, 2016* Zika Virus RNA Qualitative Real-Time RT-PCR Focus Diagnostics, Inc. (subsidiary of Quest Diagnostics) May 13, 2016* RealStar Zika Virus RT-PCR Kit U.S. Altona […]

Date Issued	Test	Company
Feb. 26, 2016*	CDC Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay	Zika MAC-ELISA
March 17, 2016*	CDC Trioplex Real-time RT-PCR Assay	Trioplex rRT-PCR
April 28, 2016*	Zika Virus RNA Qualitative Real-Time RT-PCR	Focus Diagnostics, Inc. (subsidiary of Quest Diagnostics)
May 13, 2016*	RealStar Zika Virus RT-PCR Kit U.S.	Altona Diagnostics GmbH
June 17, 2016*	Aptima Zika Virus assay	Hologic, Inc.
July 19, 2016	Viracor-IBT Laboratories, Inc.'s Zika Virus Real-time RT-PCR Test	Viracor-IBT
July 29, 2016*	VERSANT® Zika RNA 1.0 Assay (kPCR) Kit	Siemens Healthcare Diagnostics Inc.
Aug. 4, 2016*	xMAP® MultiFLEX™ Zika RNA Assay	Luminex Corporation
Aug. 17, 2016	ZIKV Detect™ IgM Capture ELISA	InBios International, Inc.
Aug. 26, 2016*	LightMix® Zika rRT-PCR Test	Roche Molecular Systems, Inc.
Sept. 23, 2016	Sentosa® SA ZIKV RT-PCR Test	Vela Diagnostics USA, Inc.
Sept. 28, 2016	Zika Virus Detection by RT-PCR Test	ARUP Laboratories
Nov. 21, 2016*	Abbott RealTime ZIKA	Abbott Molecular Inc.
Abbott Molecular Inc.	Abbott Molecular Inc.	ELITechGroup Inc. Molecular Diagnostics