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未完成美国EUA申请的新冠IVD可以在美国上市吗
日期：2021年03月19日
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大家好，我是小编麦洛克。上一次我们总结了FDA已经紧急授权超过300个IVD产品。今天我们进一步分享下未获得EUA的IVD如何在美国上市以及有哪些COVID-19 IVD生产商正在美国销售产品。

对于只供给有CLIA ( Clinical Laboratory ImprovementAmendments)认证的实验室使用的新冠体外诊断试剂， FDA 允许生产商，在未获得EUA之前，在一定的合理时间内经销产品。前提条件是生产商已经验证了IVD产品的性能而且正在准备申请EUA， 目前FDA认为合理的准备EUA申请的时间是15个工作日。

未获得EUA的生产商在经销前仍需告知FDA，其正在准备EUA, FDA将状态信息公布在FDA网页列表并保持跟踪。如果EUA申请在超过FDA认可的合理时间后 （及 15 个工作日）未被递交或者合理时间内产品发现严重问题，FDA 会将生产商/产品从列表中除名。

下面表格中是目前96个已经通知FDA，允许经销新冠IVD产品的生产商。

-  有两种批准状态 （1）获得了FDA 批准(2)还未获FDA批准，但在合理时间内。

-  使用设置为 H 或 M，分别代表CLIA 认证了的可以做高复杂(High)或中度（Moderate）复杂测是的实验室。


Manufacturer and Test

Authorization Status

Setting for Use

BD BioGx SARS-CoV-2 Reagents for BD MAX System

FDA Authorized

H, M

BGI Genomics Co. Ltd

FDA Authorized

H

Biomeme, Inc. Biomeme SARS-CoV-2 test kit

FDA Authorized

H

ChromaCode, Inc. HDPCR SARS-CoV-2 Assay

FDA Authorized

H

Co-Diagnostics, Inc.

FDA Authorized

H

Detectachem Inc., MD-Bio BCC19

FDA Authorized

H

Enzo Biochem, Inc Enzo AMPIPROBE® SARS-CoV-2 Test System

FDA Authorized

H

Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay

FDA Authorized

H

Gencurix Inc. GenePro SARS-CoV-2 Test

FDA Authorized

H

GenMark Diagnostics, Inc. ePlex Respiratory Pathogen Panel 2 (ePlex RP2  Panel)

FDA Authorized

H, M

GK Pharmaceuticals Contract Manufacturing Operations, ACCU-RIGHT  SARS-COV-2 RT-PCR KIT

FDA Authorized

H

Hologic Aptima SARS-CoV-2 Assay Pooled Samples Workflow

FDA Authorized

H

Hologic Panther Fusion SARS-CoV-2 Assay Pooled Samples Workflow

FDA Authorized

H

Hologic, Inc. Aptima SARS-CoV-2 assay

FDA Authorized

H

LabGenomics, Co., Ltd. LabGun™ COVID-19 Assay kit

FDA Authorized

H

OPTOLANE Technologies Inc. Kaira 2019-nCoV Detection Kit

FDA Authorized

H

OSANG Healthcare Co., Ltd, GeneFinder COVID-19 Plus RealAmp Kit

FDA Authorized

H

QIAGEN QIAstat-Dx Respiratory SARS-CoV-2 Panel Assay

FDA Authorized

H, M

Roche Molecular Systems Pooling Sample Workflow for the cobas®  SARS-CoV-2 for use on the cobas® 6800/8800 Systems

FDA Authorized

H, M

RTA Labs DIAGNOVITAL SARS-CoV-2

FDA Authorized

H

Solgent Co. Ltd., COVID-19 DiaplexQ Diagnostic Kit

FDA Authorized

H

T2Biosystems, Inc., T2SARS-CoV-2 Panel

FDA Authorized

H

Vela Operations Singapore Pte Ltd. ViroKey SARS-CoV-2 RT-PCR Test v2.0

FDA Authorized

H

VelaDxViroKey™ SARS-CoV-2 RT-PCR Test

FDA Authorized

H

ZhuHaiSinochips Bioscience Co., Ltd COVID-19 Real-time PCR Test Kit

FDA Authorized

H

Aegle Rapid COVID-19 Antigen Test

Not  FDA Authorized

H

Agena Bioscience SARS-CoV-2 Panel

Not  FDA Authorized

H

American BioSources Inc., DBA Genomic Diagnostics GDxGrandPerformance  SARS-CoV-2 Detection Kit

Not  FDA Authorized

H

AMSBIOInc., A+CheQ COVID-19 High-Speed RT-qPCR Detection Kit

Not  FDA Authorized

H

Applied Biological Materials Inc. (abm), GenomeCoV19 Detection Kit

Not  FDA Authorized

H

Beckman Coulter Access SARS-CoV-2 Antigen

Not  FDA Authorized

H

Biocartis NV, Idylla™ SARS-CoV-2 Test

Not  FDA Authorized

H

BioGenex Laboratories, Inc., BGX COVID-19 RT-PCR

Not  FDA Authorized

H

BioGX Inc, Xfree COVID-19 Direct RT-PCR

Not  FDA Authorized

H

BIONEER Corporation, AccuPower SARS-CoV-2 Multiplex Real-Time RT-PCR Kit

Not  FDA Authorized

H

Biopoa, Co. Ltd., Rapid COVID-19 PoaCheck

Not  FDA Authorized

H

Biosynex Rapid COVID-19 Antigen Test

Not  FDA Authorized

H

BioZentech Co., Ltd., BZ QPCR COVID-19 Kit

Not  FDA Authorized

H

CardiAI Inc., CoviLampTM Fluorometric Test Kit

Not  FDA Authorized

H

Caspr Biotech Corporation, CasprLyo-CRISPR SARS-CoV-2

Not  FDA Authorized

H

Caspr Biotech Corporation, Direct CasprLyo-CRISPR SARS-CoV-2

Not  FDA Authorized

H

Chai Inc., COVID-19 Saliva Dx Test Kit

Not  FDA Authorized

H

CLINITEST Rapid COVID-19 Antigen Test

Not  FDA Authorized

H

Clinomics USA Inc., TrioDx RT-PCR COVID-19 Test

Not  FDA Authorized

H

DiaSorin Inc. LIAISON SARS-CoV-2 Ag

Not  FDA Authorized

H

DowGene Co., Ltd., Dow QuickFinderTM 2019-nCov Real-Time PCR Kit

Not  FDA Authorized

H

ELITechGroupMDx LLC SARS-CoV-2 ELITe MGB Assay

Not  FDA Authorized

H

Ender diagnostics ag, Ender LAB COVID-19 isothermal PCR detection kit

Not  FDA Authorized

H

Eryigit medical Devices, SentebiolabSenteligo SARS CoV-2 (COVID-19)  Multiplex qPCR Detection Kit

Not  FDA Authorized

H

Eurofins ARCA Technology, Inc., ARCA Straight Shot SARS-CoV-2 Extraction  Free (EF) Assay

Not  FDA Authorized

H

Genedrive Diagnostics Ltd., Genedrive ®96 SARS-CoV2 kit

Not  FDA Authorized

H

GeneOne Diagnostics Corporation COVID-19 Nucleic Acid Diagnostic Kit

Not  FDA Authorized

H

General Biologicals Corporation, GB SARS-CoV-2 Real-Time RT-PCR

Not  FDA Authorized

H

GeneReach Biotechnology Corporation POCKIT Central SARS-CoV-2

Not  FDA Authorized

H

Genes Laboratories, NEXdiaTM 2019-nCoV Detection Kit

Not  FDA Authorized

H

Genetic Signatures Limited, EasyScreen™ SARS-CoV-2 Detection Kit (RP011  and RP012)

Not  FDA Authorized

H

GenMark Diagnostics, Inc., eSensor SARS-CoV-2 Panel

Not  FDA Authorized

H

Genomictree, Inc. AccuraDTect SARS-CoV-2-qPCR Kit

Not  FDA Authorized

H

Genrui Biotech Inc, Novel Coronavirus (2019-nCoV) Nucleic Acid Detection  Kit (RT-PCR)

Not  FDA Authorized

H

Gerbion GmbH & Co. KG., Gerbion virellaSARS-CoV-2 seqc real time  RT-PCR Kit 2.0

Not  FDA Authorized

H

GreenRoads Diagnostics LLC, GreenRoads Dx SARS-CoV-2™ Test

Not  FDA Authorized

H

Grifols Diagnostic Solutions Inc. Procleix SARS-CoV-2 Assay

Not  FDA Authorized

H

GUANGDONG ARDENT BIOMED Co., Ltd, Novel Coronavirus (COVID-19) Nucleic  Acid Detection Kit (PCR-fluorescent Probe)

Not  FDA Authorized

H

Healgen Rapid COVID-19 Antigen Test

Not  FDA Authorized

H

iCubate, Inc., iC-COVID-19 Assay

Not  FDA Authorized

H

Illucidx Inc., Illucidx COVID-19 Dx RT-LAMP

Not  FDA Authorized

H

Jiangsu Code Biomedical Technology Co. Ltd., CodeCheckSARS-CoV-2 RT-PCR  Kit

Not  FDA Authorized

H

LGC Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR  Test

Not  FDA Authorized

H

LMSI, LLC d/b/a Lighthouse Lab Services, CovidNow SARS-CoV-2 Assay Kit

Not  FDA Authorized

H

LMSI, LLC d/b/a Lighthouse Lab Services, SalivaNow SARS-CoV-2 Assay Kit

Not  FDA Authorized

H

LuminUltra Technologies Ltd., GeneCount® COVID-19 RT-qPCR Assay Kit

Not  FDA Authorized

H

Meridian Bioscience Inc., Revogene® SARS-CoV-2 assay

Not  FDA Authorized

H

Merlin Biomedical (Xiamen) Co. Ltd., Novel Coronavirus (COVID-19) RT-PCR  Kit

Not  FDA Authorized

H

MiCo BioMed Co., Ltd. Veri-Q COVID-19 Multiplex Detection Kit

Not  FDA Authorized

H

MiRXES Pte Ltd,  MiRXES Fortitude Kit 3.0 COVID-19 RT-PCR Test

Not  FDA Authorized

H

Molecular Epidemiology Inc., IEH SARS-CoV-2 RT-PCR Test

Not  FDA Authorized

H

Nanjing Liming Bio-Products Co., Ltd., StrongStep® Novel Coronavirus  (SARS-CoV-2) Multiplex Real-Time PCR Kit

Not  FDA Authorized

H

NovaTecImmundiagnosticsaGmBH GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR

Not  FDA Authorized

H

Ortho Clinical Diagnostics VITROS Immunodiagnostic Products SARS-CoV-2  Ag Assay (Reagent Pack / Calibrators)

Not  FDA Authorized

H

ProteomeTech Inc. GENEdania COVID-19 qRT-PCR

Not  FDA Authorized

H

RTA LaboratuvarlariBiyolojikUrunlerIlacveMakine San. Tic. A.S.,  Diagnovital SARS-CoV-2 Multiplex

Not  FDA Authorized

H

Sacace Biotechnologies s.r.1., SARS-CoV-2 Real-TM

Not  FDA Authorized

H

Sanigen Co. Ltd., Genelix™ COVID-19 Real-Time PCR Kit

Not  FDA Authorized

H

Sanwa BioTech Limited ALiA SARS-CoV-2 Antigen FIA Test

Not  FDA Authorized

H

Shimadzu Corporation, 2019 Novel Coronavirus Detection Kit

Not  FDA Authorized

H

SML GENETREE Co., Ltd. Ezplex SARS-CoV-2 G Kit

Not  FDA Authorized

H

Suzhou PreciGenome, Ltd., Co., Fastplex Triplex SARS-CoV-2 Detection Kit  (RT-PCR)

Not  FDA Authorized

H

TAAG Genetics S.A. nPLEX SARS-CoV-2 Detection Kit

Not  FDA Authorized

H

Taigen Bioscience Corporation LabTurbo AIO COVID-19 RNA Testing kit

Not  FDA Authorized

H

TCM Bioscience, TCM-Q Corona III test

Not  FDA Authorized

H

Tetracore, Inc., EZ-SARS-CoV-2 Real-Time RT-PCR

Not  FDA Authorized

H

Thermo Fisher Scientific, TaqPath™ COVID 19 High Throughput Combo Kit  (also called "The Amplitude™ Solution with the TaqPath™ COVID 19 High  Throughput Combo Kit")

Not  FDA Authorized

H

Todos Medical USA Inc., TODOS 2019-nCoV RT-qPCR Detection Kit

Not  FDA Authorized

H

UStar Biotechnologies (Hangzhou) Ltd., EasyNAT® Diagnostic Kit for  Novel-Coronavirus (COVID-19) RNA (Isothermal Amplification-Real Time  Fluorescence Assay)

Not  FDA Authorized

H

Verasure Rapid COVID-19 Antigen Test

Not  FDA Authorized

H

YD Diagnostics Corp. MolecuTech Real-Time COVID-19

Not  FDA Authorized

H



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