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【麥祥時訊】未完成美國EUA申請的新冠IVD可以在美國上市嗎
大家好,我是小編麥洛克。上一次我們總結(jié)了FDA已經(jīng)緊急授權(quán)超過300個IVD產(chǎn)品。今天我們進(jìn)一步分享下未獲得EUA的IVD如何在美國上市以及有哪些COVID-19 IVD生產(chǎn)商正在美國銷售產(chǎn)品。
對于只供給有CLIA ( Clinical Laboratory ImprovementAmendments)認(rèn)證的實(shí)驗(yàn)室使用的新冠體外診斷試劑, FDA 允許生產(chǎn)商,在未獲得EUA之前,在一定的合理時間內(nèi)經(jīng)銷產(chǎn)品。前提條件是生產(chǎn)商已經(jīng)驗(yàn)證了IVD產(chǎn)品的性能而且正在準(zhǔn)備申請EUA, 目前FDA認(rèn)為合理的準(zhǔn)備EUA申請的時間是15個工作日。
未獲得EUA的生產(chǎn)商在經(jīng)銷前仍需告知FDA,其正在準(zhǔn)備EUA, FDA將狀態(tài)信息公布在FDA網(wǎng)頁列表并保持跟蹤。如果EUA申請?jiān)诔^FDA認(rèn)可的合理時間后 (及 15 個工作日)未被遞交或者合理時間內(nèi)產(chǎn)品發(fā)現(xiàn)嚴(yán)重問題,F(xiàn)DA 會將生產(chǎn)商/產(chǎn)品從列表中除名。
下面表格中是目前96個已經(jīng)通知FDA,允許經(jīng)銷新冠IVD產(chǎn)品的生產(chǎn)商。
-  有兩種批準(zhǔn)狀態(tài) (1)獲得了FDA 批準(zhǔn)(2)還未獲FDA批準(zhǔn),但在合理時間內(nèi)。
-  使用設(shè)置為 H 或 M,分別代表CLIA 認(rèn)證了的可以做高復(fù)雜(High)或中度(Moderate)復(fù)雜測是的實(shí)驗(yàn)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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