fda에서중국 진단키트는 승인받았는데 우리 진단키트는 아직도 ?

Date EUA Issued	Manufacturer	Diagnostic (Letter of Authorization)	Fact Sheet for Healthcare Providers	Fact Sheet for Patients	Manufacturer Instructions / Package Insert	Other docunemts
04/07/2020	InBios International, Inc	Smart Detect SARS-CoV-2 rRT-PCR Kit	Healthcare Providers	Patients	IFU	None
04/06/2020	Gnomegen LLC	Gnomegen COVID-19 RT-Digital PCR Detection Kit	Healthcare Providers	Patients	IFU	None
04/03/2020	Co-Diagnostics, Inc.	Logix Smart Coronavirus Disease 2019 (COVID-19) Kit	Healthcare Providers	Patients	IFU	None
04/03/2020	ScienCell Research Laboratories	ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit	Healthcare Providers	Patients	IFU	None
04/03/2020	Luminex Corporation	ARIES SARS-CoV-2 Assay	Healthcare Providers	Patients	IFU	None
04/02/2020	Becton, Dickinson & Company (BD)	BioGX SARS-CoV-2 Reagents for BD MAX System	Healthcare Providers	Patients	IFU	None
04/01/2020	Ipsum Diagnostics, LLC	COV-19 IDx assay	Healthcare Providers	Patients	EUA Summary	None
04/01/2020	Cellex Inc.	qSARS-CoV-2 IgG/IgM Rapid Test	Healthcare Providers	Patients	IFU	None
03/30/2020	QIAGEN GmbH	QIAstat-Dx Respiratory SARS-CoV-2 Panel	Healthcare Providers	Patients	IFU	None
03/30/2020	NeuMoDx Molecular, Inc.	NeuMoDx SARS-CoV-2 Assay	Healthcare Providers	Patients	IFU	None
03/27/2020	Luminex Molecular Diagnostics, Inc.	NxTAG CoV Extended Panel Assay	Healthcare Providers	Patients	IFU	None
03/27/2020	Abbott Diagnostics Scarborough, Inc.	ID NOW COVID-19	Healthcare Providers	Patients	IFU	None
03/26/2020	BGI Genomics Co. Ltd	Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV	Healthcare Providers	Patients	IFU	None
03/25/2020	Avellino Lab USA, Inc.	AvellinoCoV2 test	Healthcare Providers	Patients	EUA Summary	None
03/24/2020	PerkinElmer, Inc.	PerkinElmer New Coronavirus Nucleic Acid Detection Kit	Healthcare Providers	Patients	IFU	Letter Granting EUA Amendment(s) (April 1, 2020)
03/23/2020	Mesa Biotech Inc.	Accula SARS-Cov-2 Test	Healthcare Providers	Patients	IFU	None
03/23/2020	BioFire Defense, LLC	BioFire COVID-19 Test	Healthcare Providers	Patients	IFU	None
03/20/2020	Cepheid	Xpert Xpress SARS-CoV-2 test	Healthcare Providers	Patients	IFU for Labs IFU for Point-of-Care	None
03/20/2020	Primerdesign Ltd.	Primerdesign Ltd COVID-19 genesig Real-Time PCR assay	Healthcare Providers	Patients	IFU	None
03/19/2020	GenMark Diagnostics, Inc.	ePlex SARS-CoV-2 Test	Healthcare Providers	Patients	IFU	None
03/19/2020	DiaSorin Molecular LLC	Simplexa COVID-19 Direct assay	Healthcare Providers	Patients	IFU	Letter Granting EUA Amendment(s) (March 26, 2020)
03/18/2020	Abbott Molecular	Abbott RealTime SARS-CoV-2 assay	Healthcare Providers	Patients	IFU	Letter Granting EUA Amendment(s) (April 1, 2020)
03/17/2020	Quest Diagnostics Infectious Disease, Inc.	Quest SARS-CoV-2 rRT-PCR	Healthcare Providers	Patients	IFU	Letter Granting EUA Amendment(s) (March 26, 2020)
03/17/2020	Quidel Corporation	Lyra SARS-CoV-2 Assay	Healthcare Providers	Patients	IFU	Letter Granting EUA Amendment(s) (March 23, 2020)
03/16/2020	Laboratory Corporation of America (LabCorp)	COVID-19 RT-PCR Test	Healthcare Providers	Patients	EUA Summary	None
03/16/2020	Hologic, Inc.	Panther Fusion SARS-CoV-2	Healthcare Providers	Patients	IFU	None
03/13/2020	Thermo Fisher Scientific, Inc.	TaqPath COVID-19 Combo Kit	Healthcare Providers	Patients	IFU	Letter Granting EUA Amendment(s) (March 24, 2020)
03/12/2020	Roche Molecular Systems, Inc. (RMS)	cobas SARS-CoV-2	Healthcare Providers	Patients	IFU	Letter Granting EUA Amendment(s) (March 31, 2020)
02/29/2020	Wadsworth Center, New York State Department of Public Health's (CDC)	New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel	Healthcare Providers	Patients	IFU	Letter Granting EUA Amendment(s) (March 15, 2020)
02/04/2020	Centers for Disease Control and Prevention's (CDC)	CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC)	Healthcare Providers	Patients	IFU	Letter Granting EUA Amendment(s) (March 30, 2020)