Tests with EUA
COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test (a) = Antigen Test (t) = Total Antibody Test (m) = Multi-analyte Test) Date Manufacturer(s) Test Receiving EUA Mar 31 Becton Dickinson BD Veritor System for Rapid Detection of SARS-CoV-2(a) for serial use Mar 31 Abbott BinaxNOW COVID-19 Ag Card 2 Home Test(a) for home use Mar 31 Abbott BinaxNOW COVID-19 Antigen Self Test(a) for serial use Mar 31 Quidel QuickVue At-Home OTC COVID-19 Test(a) for serial use Mar 31 NeuMoDx Molecular NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay Mar 29 Amazon Amazon Real-Time RT-PCR Test Mar 29 Becton Dickinson BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B(a) Mar 26/May 14,2020 Hologic Aptima SARS-CoV-2 assay reissued for pooling and screening uses Mar 25 Siemens Healthineers Atellica IM SARS-CoV-2 IgG antibody test(s) Mar 23 Twist Bioscience SARS-CoV-2 NGS Assay Mar 23 Beckman Coulter Access SARS-CoV-2 IgG II rapid antibody test(s) Mar 22/Oct 1, 2020 Tempus Labs, Inc. iC SARS-CoV2 test/Reissued for home collection Mar 19/Aug 31, 2020 Color Health Color COVID-19 Self-Swab Collection Kit/Reissued for home collection and screening Mar 19 Color Health Color COVID-19 Self-Swab Collection Kit DTC for home collection and screening Mar 19 Color Health […]
COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION
((s) = Serology Test
(a) = Antigen Test
(t) = Total Antibody Test
(m) = Multi-analyte Test)
| Date | Manufacturer(s) | Test Receiving EUA |
| Mar 31 | Becton Dickinson | BD Veritor System for Rapid Detection of SARS-CoV-2(a) for serial use |
| Mar 31 | Abbott | BinaxNOW COVID-19 Ag Card 2 Home Test(a) for home use |
| Mar 31 | Abbott | BinaxNOW COVID-19 Antigen Self Test(a) for serial use |
| Mar 31 | Quidel | QuickVue At-Home OTC COVID-19 Test(a) for serial use |
| Mar 31 | NeuMoDx Molecular | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay |
| Mar 29 | Amazon | Amazon Real-Time RT-PCR Test |
| Mar 29 | Becton Dickinson | BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B(a) |
| Mar 26/May 14,2020 | Hologic | Aptima SARS-CoV-2 assay reissued for pooling and screening uses |
| Mar 25 | Siemens Healthineers | Atellica IM SARS-CoV-2 IgG antibody test(s) |
| Mar 23 | Twist Bioscience | SARS-CoV-2 NGS Assay |
| Mar 23 | Beckman Coulter | Access SARS-CoV-2 IgG II rapid antibody test(s) |
| Mar 22/Oct 1, 2020 | Tempus Labs, Inc. | iC SARS-CoV2 test/Reissued for home collection |
| Mar 19/Aug 31, 2020 | Color Health | Color COVID-19 Self-Swab Collection Kit/Reissued for home collection and screening |
| Mar 19 | Color Health | Color COVID-19 Self-Swab Collection Kit DTC for home collection and screening |
| Mar 19 | Color Health | Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC for home collection and screening |
| Mar 18/May 1, 2020 | BioFire Diagnostics (Biomérieux subsidiary) | BioFire Respiratory Panel 2.1 (RP2.1)(m)/Withdrawn and reissued as de novo clearance |
| Mar 9 | GetMyDNA | GetMyDNA COVID-19 Test Home Collection Kit |
| Mar 5 | Broad Institute | CRSP SARS-CoV-2 Real-time Reverse Transcriptase-PCR Diagnostic Assay (Version 3) |
| Mar 5 | Adaptive Technologies | T-Detect COVID-19 Test, which uses immune repertoire sequencing technology to identify adaptive T-cell response to SARS-CoV-2(s) |
| Mar 5 | Cue Health | Cue COVID-19 Test for home + over-the-counter use |
| Mar 1 | Luminex | Expanded version of multiplex NxTag Respiratory Pathogen Panel that includes a SARS-CoV-2 target |
| Mar 1 | Abbott Laboratories | AdviseDx SARS-CoV-2 IgG II test(s) |
| Mar 1 | Quidel | QuickVue At-Home COVID-19 test |
| Feb 26 /Aug 25 | Fluidigm | Advanta Dx SARS-CoV-2 RT-PCR assay/Reissued for use with Azova COVID-19 Test Collection Kit |
| Feb 26 | Viracor Eurofins Clinical | Viracor SARS-CoV-2 assay DTC |
| Feb 26 /Oct 15 | Clinical Enterprise, Inc. | EmpowerDX At-Home COVID-19 PCR Test Kit/Reissued for direct to consumer use and for screening |
| Feb 24 | University of Illinois | covidSHIELD for home collection and use of saliva samples |
| Feb 22 /Aug 28 | DxTerity Diagnostics, Inc. | DxTerity SARS-CoV-2 RT-PCR Test/Reissued for use on saliva samples and home collection |
| Feb 13 | Gravity Diagnostics, LLC | Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits for home collection and screening |
| Feb 13 | Immunodiagnostic Systems' | IDS SARS-CoV-2 IgG(s) |
| Feb 13 | Assurance Scientific Laboratories | Assurance SARS-CoV-2 Panel DTC for home collection and screening |
| Feb 13 /Jun 30 | The Kroger Co. | Kroger Health COVID-19 Test Home Collection Kit/Reissued to allow for use in screening |
| Feb 13 | Everlywell Inc. | Everlywell COVID-19 Test Home Collection Kit DTC |
| Feb 12 /Dec 17 | Genetworx | Genetworx COVID-19 Nasal Swab Test/Reissued for home collection |
| Feb 11 | Bio-Rad | Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit |
| Feb 10 | Becton Dickinson | BD SARS-CoV-2/Flu assay |
| Feb 10 | Thermo Fisher Scientific | Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit |
| Feb 10 | Grifols Diagnostic Solutions | Procleix SARS-CoV-2 Assay |
| Feb 10 | Visby Medical | Single-use, palm-held rapid point-of-care COVID-19 PCR test |
| Feb 5 (March 24/Oct 30) | PerkinElmer | New Coronavirus Nucleic Acid Detection Kit/Reissued to allow use on pooled samples and for screening |
| Feb 5 | Yale School of Public Health | Saliva Direct test |
| Feb 4 | Princeton BioMeditech | Status COVID-19/Flu test |
| Feb 4 | Clinomics | TrioDx RT-PCR COVID-19 Test |
| Jan 26 | Ambry Genetics | Ambry COVID-19 RT-PCR Test |
| Jan 15 | United Biomedical | UBI SARS-CoV-2 ELISA(s) |
| Jan 15 | Bio-Rad Laboratories | Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit |
| Jan 13 | SML Genetree | Ezplex SARS-CoV-2 G Kit including for use on pooled specimens |
| Jan 12 | Phadia (Thermo Fisher Scientific Swedish subsidiary) | EliA SARS-CoV-2-Sp1 IgG Test(s) |
| Jan 12 | Ortho Clinical Diagnostics | Vitros SARS-CoV-2 Antigen test, first high-volume COVID-19 antigen test to get EUA(a) |
| Jan 11 | Advaite | RapCov Rapid COVID-19 Test(s) |
| Jan 11 | Siemens Healthineers | Dimension EXL SARS CoV 2 IgG (CV2G)(s) |
| Jan 11 | Siemens Healthineers | Dimension Vista SARS CoV 2 IgG (COV2G)(s) |
| Jan 7 | Siemens Healthineers | IL-6 assay(s) |
| Jan 6 | Quanterix | Simoa SARS-CoV-2 N Protein Antigen Test(a) |
| Jan 6 | Nirmidas Biotech | MidaSpot COVID-19 Antibody Combo Detection Kit for point of care use(s) |
| 2021 | ||
| Dec 29 | Cepheid | Xpert Xpress SARS-CoV-2 DoD test for use by DoD labs |
| Dec 28 | Quanterix | Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody test(s) |
| Dec 21 | MatMaCorp | MatMaCorp COVID-19 2SF Test |
| Dec 18 | Quidel | QuickVue SARS Antigen test(a) |
| Dec 17 | Acon Laboratories | ACON SARS-CoV-2 IgG/IgM Rapid Test(s) |
| Dec 17 | Hologic | Aptima SARS-CoV-2/Flu assay for SARS-CoV-2, influenza A, and/or influenza B(m) |
| Dec 17 | PacificDx | PacificDx COVID-19 Test |
| Dec 15 | Ellume | Ellume COVID-19 Home Test, first all-in-one, over-the-counter test for performing at home to get EUA |
| Dec 10 | LabCorp | Pixel by LabCorp COVID-19 Test Home Collection Kit for over-the-counter sale |
| Dec 8 | Luminostics | Clip COVID Rapid Antigen Test(a) |
| Dec 5 | Quest | RC COVID-19 +Flu RT-PCR test for prescription use, first test for at-home, self-collection of samples for SARS-CoV-2 and influenza A/B to get EUA(m) |
| Dec 4 | Innovita Biological Technology | Innovita 2019-nCoV Ab Test (Colloidal Gold) (s) |
| Dec 1 | Cepheid | Xpert Omni SARS-CoV-2 test |
| Dec 1 | Roche | Elecsys Anti-SARS-CoV-2 S electrochemiluminescence immunoassay(s) |
| Nov 28 | RapidRona | RapidRona Self-Collection Kit for at-home collection of nasal swab specimens |
| Nov 23/Dec 23 | Gravity Diagnostics | Gravity Diagnostics SARS-CoV-2 RT-PCR assay/Reissued to allow home collection, use for asymptomatic screening and on saliva samples |
| Nov 18 | Lucira Health | Lucira COVID-19 All-in-One Test Kit, first from COVID-19 assay for rapid self-testing at home to get EUA |
| Nov 9 | GenScript Biotech | cPass SARS-CoV-2 Neutralization Antibody Detection Kit, first SARS-CoV-2 neutralizing antibody test to get EUA |
| Oct 30 | Quansys Biosciences | Q-Plex SARS-CoV-2 Human IgG (4 Plex) immunoassay(s) |
| Oct 29 | DNA Genotek Inc. | ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100 saliva collection devices |
| Oct 26 | Agena Bioscience | MassArray SARS-CoV-2 Panel |
| Oct 26 | Celltrion | Sampinute COVID-19 Antigen MIA(a) |
| Oct 20 | binx health, Inc. | binx health At-Home Nasal Swab COVID-19 Sample Collection Kit |
| Oct 14 | DNA Genotek Inc. | OMNIgene·ORAL OM-505 and OME-505 (OMNIgene·ORAL) saliva collection devices |
| Oct 14 | LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 RNA STAR Complete |
| Oct 12 | Abbott Laboratories | AdviseDx SARS-CoV-2 IgM serology test(s) |
| Oct 9 | Beckman Coulter | Access SARS-CoV-2 Immunoglobulin M (IgM) assay(s) |
| Oct 8 | Access Bio | CareStart COVID-19 Antigen test(a) |
| Oct 8 | Genalyte | Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2(s) |
| Oct 6 | UCLA | UCLA SwabSeq COVID-19 Diagnostic Platform |
| Oct 5 | Seasun Biomaterials Inc. | AQ-TOP COVID-19 Rapid Detection Kit PLUS |
| Oct 2 | Thermo Fisher Scientific | OmniPath COVID-19 Total Antibody ELISA Test(s) |
| Oct 2 | Quidel | Sofia 2 Flu + SARS Antigen FIA(a)(m) |
| Oct 2 | BioFire Diagnostics | BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ)(m) |
| Oct 1 | Beckman Coulter | Access Interleukin-6 (IL-6) immunoassay(s) |
| Sept 30 | Alimetrix, Inc. | Alimetrix SARS-CoV-2 RT-PCR Assay |
| Sept 30 | Nirmidas Biotech | Nirmidas COVID-19 IgM/IgG Antibody Detection Kit(s) |
| Sept 30 | NanoEntek America | Frend COVID-19 total Ab immunoassay(s) |
| Sept 30 | DiaSorin | Liaison SARS-CoV-2 IgM Assay(s) |
| Sept 30 | Aeon Global Health | Aeon Global Health SARS-CoV-2 Assay |
| Sept 29 | Centogene | CentoSure SARS-CoV-2 RT-PCR Assay |
| Sept 29 | Akron Children’s Hospital | Akron Children’s Hospital SARS-CoV-2 Assay |
| Sept 29 | National Jewish Health | SARS-CoV-2 MassArray Test |
| Sept 28 | Quotient Limited | SARS-CoV-2 antibody test run on firm’s MosaiQ platform for blood grouping and transfusion-transmitted infection screening(s) |
| Sept 25 | PerkinElmer, Inc. | PerkinElmer New Coronavirus Nucleic Acid Detection Kit |
| Sept 25 | Genetrack Biolabs | Genetrack SARS-CoV-2 Molecular test |
| Sept 24 | Jiangsu Well Biotech | Orawell IgM/IgG Rapid Test(s) |
| Sept 24 | Cepheid | Xpert Xpress SARS-CoV-2/Flu/RSV test(m) |
| Sept 24 | Clear Labs | Clear Dx SARS-CoV-2 novel descriptive diagnostic, first nanopore sequencing-based test for SARS-CoV-2 to receive EUA |
| Sept 23 | Assure Tech | Assure COVID-19 IgG/IgM Rapid Test Device(S), point of care serology test |
| Sept 21 | KimForest Enterprise Co. | KimForest SARS-CoV-2 Detection Kit v109/21/2020 |
| Sept 18 | Bio-Rad Laboratories | Bio-Rad SARS-CoV-2 ddPCR Test |
| Sept 18 | Infinity BiologiX | Infinity BiologiX TaqPath SARS-CoV-2 Assay including for home collection |
| Sept 18 | GK Pharmaceuticals Contract Manufacturing Operations | TGK Accu-Right SARS-CoV-2 RT-PCR Kit |
| Sept 17 | Abbott Diagnostics | ID NOW COVID-19 |
| Sept 16 | Visby Medical, Inc. | Visby Medical COVID-19 RT-PCR test |
| Sept 15 | Hologic | Aptima SARS-CoV-2 assay |
| Sept 15 | Color Genomics | Color COVID-19 Self-Swab Collection Kit |
| Sept 14 | Roche | cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on cobas Liat System(m) |
| Sept 9 | Kaiser Permanente Mid-Atlantic States | KPMAS COVID-19 Test, including for home collection use |
| Sept 9 | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | Wantai SARS-CoV-2 RT-PCR Kit |
| Sept 8/Dec 22 | Verily Life Sciences | Verily COVID-19 RT-PCR Test for pooled sampling testing/Reissued to allow home collection |
| Sept 8 | BillionToOne, Inc. | qSanger-COVID-19 Assay |
| Sept 4 | Sugentech | SGTi-flex COVID-19 IgG(s) |
| Sept 2 | Roche | Cobas SARS-CoV-2 & Influenza A/B multi-analyte assay(m) |
| Sept 2 | Bioeksen R&D Technologies | Bio-Speedy Direct RT-qPCR SARS-CoV-2 |
| Sept 1 | Detectachem Inc. | MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit |
| Sept 1 | OPTOLANE Technologies | Kaira 2019-nCoV Detection Kit |
| Aug 31 | TBG Biotechnology | TBG SARS-CoV-2 IgG/IgM Rapid Test Kit(s) |
| Aug 31 | University of Arizona | COVID-19 ELISA pan-Ig Antibody Test(s) |
| Aug 31 | T2 Biosystems, Inc. | T2SARS-CoV-2 Panel |
| Aug 31 | MiraDx | MiraDx SARS-CoV-2 RT-PCR assay for saliva and home collection |
| Aug 31 | Mammoth Biosciences, Inc. | SARS-CoV-2 DETECTR Reagent Kit |
| Aug 31/Jan 28 | BayCare Laboratories | BayCare SARS-CoV-2 RT PCR Assay/Reissued to allow for use with pooling |
| Aug 28 | Patients Choice Laboratories | PCL SARS-CoV-2 Real-Time RT-PCR Assay |
| Aug 25/Dec 16 | Abbott Laboratories | Abbott's BinaxNow COVID-19 Ag Card(a)/Reissued to allow virtually guided at-home use |
| Aug 25 | Biocan Diagnostics | Tell Me Fast Novel Coronavirus IgG/IgM Antibody Test(s) |
| Aug 25 | QDx Pathology Services | QDX SARS-CoV-2 Assay authorized for home collection |
| Aug 21 | Texas Department of State Health Services | Texas Department of State Health Services SARS-CoV-2 Assay |
| Aug 21 | Guardant Health | Guardant-19 RT-PCR, next-generation sequencing test |
| Aug 18 | LumiraDx | LumiraDx SARS-CoV-2 Ag Test(a) |
| Aug 17 | BioCheck | BioCheck SARS-CoV-2 IgM and IgG Combo Test and MS-Fast instrument |
| Aug 17 | ZhuHai Sinochips Bioscience Co., Ltd. | COVID-19 Nucleic Acid RT-PCR Test Kit |
| Aug 15 | Diazyme Laboratories | Diazyme DZ-Lite SARS-CoV-2 IgM test(s) |
| Aug 15 | Yale School of Public Health | SalivaDirect COVID-19 test, which uses a new method of processing saliva samples |
| Aug 13 | Pro-Lab Diagnostics | Pro-AmpRT SARS-CoV-2 Test |
| Aug 11 | LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 RNA STAR |
| Aug 11 | Biomeme, Inc. | Biomeme SARS-CoV-2 Real-Time RT-PCR |
| Aug 10 | Alpha Genomix Laboratories | Alpha Genomix TaqPath SARS-CoV-2 Combo Assay |
| Aug 10 | Solaris Diagnostics | Solaris Multiplex SARS-CoV-2 Assay |
| Aug 7 | George Washington University Public Health Laboratory | GWU SARS-CoV-2 RT-PCR Test |
| Aug 6 | Helix OpCo LLC (dba Helix) | Helix COVID-19 NGS Test |
| Aug 5 | Capstone Healthcare | Genus SARS-CoV-2 test |
| Aug 5 | Vela Diagnostics | Manual version of firm’s ViroKey SARS-CoV-2 RT-PCR Test |
| Aug 3 | Poplar Healthcare | Poplar SARS-CoV-2 TMA Pooling assay |
| Aug 3 | Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute | Cleveland Clinic SARS-CoV-2 Assay |
| Aug 3/Oct 20 | Wren Laboratories LLC | Wren Laboratories COVID-19 PCR Test/Reissued to allow home collection and testing on saliva samples |
| Aug 3 | Ethos Laboratories | Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay authorized for home collection |
| July 31 | Siemens Healthineers | Advia Centaur SARS-CoV-2 IgG (COV2G)(s) and Atellica IM SARS-CoV-2 IgG (COV2G)(s) |
| July 31 | Xiamen Zeesan Biotech | SARS-CoV-2 Test Kit (Real-time PCR) |
| July 31 | University of California San Diego Health | UCSD RC SARS-CoV-2 Assay approved for sample pooling |
| July 30 | Clinical Reference Laboratory (CRL) | Saliva-based COVID-19 RT-PCR test allowing for home collection |
| July 29 | Quest Diagnostics | Technique to speed extraction of viral RNA from patient samples |
| July 28 | Access Bio and Access | CareStart COVID-19 IgM/IgG SARS-CoV-2 |
| July 27 | Truvian Sciences | Easy Check COVID-19 IgM/IgG antibody test(s) |
| July 27 | Eli Lilly and Company | Lilly SARS-CoV-2 Assay |
| July 27 | Sandia National Laboratories | SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay |
| July 24 | Xiamen Biotime Biotechnology | Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test(s) |
| July 24 | Jiangsu CoWin Biotech Co., Ltd. | Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit |
| Jul 23/Oct 20 | Helix | Helix COVID-19 Test/Reissued to allow home collection and asymptomatic screening |
| July 21 | DiaCarta | QuantiVirus SARS-CoV-2 Multiplex Test Kit |
| July 18 | Quest Diagnostics | SARS-CoV-2 RNA test EUA expanded for pool sampling use |
| July 17 | Megna Health | Rapid COVID-19 IgM/IgG Combo Test Kit(s) |
| July 17 | Access Genetics | OraRisk COVID-19 RT-PCR |
| July 16 | Luminex | xMap SARS-CoV-2 Multi-Antigen IgG Assay(a) |
| July 16 | Boston Heart Diagnostics | Boston Heart COVID-19 RT-PCR Test |
| Jul 15/Aug 21 | Quest Diagnostics | Quest Diagnostics HA SARS-CoV-2 Assay/Reissued to allow home collection |
| Jul 15/Aug 21 | Quest Diagnostics | Quest Diagnostics RC SARS-CoV-2 Assay/Reissued to allow home collection |
| Jul 15/Aug/Dec 1 | Quest Diagnostics | Quest Diagnostics PF SARS-CoV-2 Assay/Reissued to include use with nasal swab specimens self-collected without healthcare provider observation/Reissued to include use with pooled samples on respiratory swab specimens collected by healthcare provider or self-collected at home |
| July 13 | KogeneBiotech Co., Ltd. | PowerChek 2019-nCoV Real-time PCR Kit |
| July 13 | Trax Management Services | PhoenixDx SARS-CoV-2 Multiplex |
| July 13 | Compass Laboratory Services | Compass Laboratory Services SARS-CoV2 Assay + home collection kit |
| July 10 | Beijing Wantai Biological Pharmacy | SARS-CoV-2 Ab Rapid Test(s) |
| July 10 | Boston Medical Center (BMC) | BMC-CReM COVID-19 Test |
| July 9 | Vela Diagnostics | Automated version of its ViroKey SARS-CoV-2 RT-PCR Test; Version 2.0 gets EUA Sept. 22 |
| July 9 | Diazyme Laboratories | Diazyme DZ-Lite SARS-CoV-2 IgG antibody test(s) |
| July 9 | BioSewoom | Real-Q 2019-nCoV Detection Kit |
| July 8 | Univ. of California, San Francisco + Mammoth Biosciences | SARS-CoV-2 RNA DETECTR Assay |
| Jul 8/Dec 17 | Clinical Research Sequencing Platform (CRSP), LLC at Broad Institute of MIT and Harvard | CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay/Reissued to allow home collection |
| July 7 | Enzo Life Sciences, Inc. | AMPIPROBE SARS-CoV-2 Test System |
| July 7/Sept 30 | Access Bio, Inc. | CareStart COVID-19 MDx RT-PCR; expanded for testing from collection of a saline oral rinse |
| July 7 | Gene By Gene | Gene By Gene SARS-CoV-2 Detection Test |
| July 6 | Assure Tech | Assure COVID-19 IgG/IgM Rapid Test Device(s) |
| July 6 | Becton Dickinson | SARS-CoV-2 antigen test runs on firm’s Veritor Plus System(a) |
| July 6 | Laboratorio Clinico Toledo | Laboratorio Clinico Toledo SARS-CoV-2 Assay |
| July 2 | CDC | Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay(m) |
| July 1 | InBios International | SCoV-2 Detect IgM ELISA kit(s) |
| July 1 | Centogene | CentoFast-SARS-CoV-2 RT-PCR Assay |
| June 30 | TNS Co., Ltd (Bio TNS) | COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit |
| June 30 | Psomagen, Inc. | Psoma COVID-19 RT Test |
| June 29 | Acupath Laboratories | COVID-19 RT-PCR Assay |
| June 29 | Beckman Coulter | Access SARS-CoV-2 IgG assay(s) |
| June 29 | LifeHope Labs | LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel |
| June 25 | Inform Diagnostics, Inc. | Inform Diagnostics SARS-CoV-2 RT-PCR Assay |
| June 25 | PreciGenome | FastPlex Triplex SARS-CoV-2 Detection Kit |
| June 25 | PlexBio | IntelliPlex SARS-CoV-2 Detection Kit |
| June 25 | Diagnostic Solutions Laboratory, LLC | DSL COVID-19 Assay |
| June 24 | Univ. of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory | MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay |
| June 23 | Babson Diagnostics | SARS-CoV-2 immunoassay(s) |
| June 23 | HealthQuest Esoterics | HealthQuest Esoterics TaqPath SARS-CoV-2 Assay |
| June 23 | Univ. of Alabama Birmingham Fungal Reference Lab | FRL SARS CoV-2 Test |
| June 23 | Gencurix | GenePro SARS-CoV-2 Test |
| June 19 | Laihe Biotech | Lyher Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit |
| June 18 | Jiangsu Bioperfectus Technologies | COVID-19 Coronavirus Real Time PCR Kit |
| Jun 18/Dec 17 | 3B Blackbio Biotech India | TRUPCR SARS-CoV-2 Kit/Reissued to allow for use on saliva samples |
| June 17 | ADS Biotec | SARS-CoV-2 Antibody Detection Kit |
| June 17 | Ohio State University | OSUWMC COVID-19 RT-PCR test |
| June 17 | Biohit Healthcare | SARS-CoV-2 IgM/IgG Antibody Test Kit |
| June 17 | Omnipathology Solutions | Omni COVID-19 ASSAY by RT-PCR |
| June 16 | Emory University | SARS-CoV-2 RBD IgG ELISA-based test(s) |
| Jun 15/Dec 11 | Applied BioCode, Inc. | BioCode SARS-CoV-2 Assay/Reissued to allow use with pooled samples |
| Jun 13/Sept 9 | Kaiser Permanente Mid-Atlantic States | KPMAS COVID-19 Test/Reissued to allow home collection and asymptomatic screening |
| June 12 | RTA Laboratories Biological Products Pharma + Machinery Industry Diagnovital | SARS-CoV-2 Real-Time PCR Kit |
| June 10 | TBG Biotechnology Corp. | ExProbe SARS-CoV-2 Testing Kit |
| June 10 | Tide Laboratories, LLC | DTPM COVID-19 RT-PCR Test |
| June 10 | Cue Health Inc. | Cue COVID-19 Test |
| June 9 | Illumina | COVIDSeq Test, first NGS assay to get EUA |
| June 9 | ChromaCode | HDPCR SARS-CoV-2 Real-Time PCR assay |
| June 8 | Siemens Healthineers | Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)(t) |
| June 8 | Siemens Healthineers | Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)(t) |
| June 8 | Euroimmun | EURORealTime SARS-CoV-2 test |
| June 5 | Genetron Health | SARS-CoV-2 RNA Test |
| June 4 | Hangzhou Biotest Biotech Co., Ltd. | RightSign COVID-19 IgG/IgM Rapid Test Cassette(s) |
| June 4 | Univ of Nebraska Medical Center | NEcov19 RT-PCR Assay |
| Jun 4/Dec 28 | Phosphorus Diagnostics LLC | Phosphorus COVID-19 RT-qPCR Test/Reissued to allow home collection and use on saliva samples |
| June 4 | Vibrant America Clinical Labs | Vibrant COVID-19 Ab Assay(s) |
| June 2 | Roche | Elecsys IL-6 immunoassay |
| June 1 | CSI Laboratories | SARS-CoV-2 RT-PCR Test |
| June 1 | Aspirus | SARS-CoV-2 rRT-PCR Assay |
| Jun 1/Sept 21 | Gravity Diagnostics, LLC | Gravity Diagnostics COVID-19 Assay/Reissued to allow home collection |
| May 29 | Healgen Scientific LLC | COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)(s) |
| May 29 | Siemens Healthineers | Atellica IM SARS-CoV-2 Total (COV2T)(t) |
| May 29 | Siemens Healthineers | ADVIA Centaur SARS-CoV-2 Total (COV2T)(t) |
| May 28 | Quest Diagnostics | Self-collection Kit for COVID-19 |
| May 28/Oct 28 | PrivaPath Diagnostics, Inc. | LetsGetChecked Coronavirus (COVID-19) Test/ Reissued to allow home collection |
| May 26 | Avera Institute for Human Genetics | SARS-CoV-2 assay detecting two regions of virus’ nucleocapsid gene |
| May 26/Nov 25 | Express Gene Molecular Diagnostics Laboratory | 2019-nCoV RT-PCR Diagnostic Panel/Expanded to include use on saliva samples |
| May 26/Sept 21 | Exact Sciences | SARS-CoV-2 (N gene detection)/Reissued to allow home collection |
| May 22 | SpectronRx | Hymon SARS-CoV-2 Test Kit |
| May 21/Oct 20 | P23 Labs, LLC | P23 Labs TaqPath SARS-CoV-2 Assay/Reissued to allow home collection and testing on saliva samples |
| May 21 | Seasun Biomaterials, Inc. | AQ-TOP COVID-19 Rapid Detection Kit |
| May 21 | SolGent Co., Ltd. | DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit |
| May 21 | BioCore Co., Ltd. | BioCore 2019 nCoV Real Time PCR Kit |
| May 20/Nov 4 | Color | SARS-CoV-2 LAMP Diagnostic Assay/Reissued to allow home collection |
| May 18 | Quidel | Lyra Direct SARS-CoV-2 Assay |
| May 15 | GeneMatrix | NeoPlex COVID-19 Detection Kit |
| May 15 | Everlywell, Inc. | Everlywell COVID-19 Test Home Collection Kit |
| May 15/Sept 21 | Assurance Scientific Labs | Assurance SARS-CoV-2 Panel/Reissued to allow home collection |
| May 15 | Fulgent Therapeutics, LLC | Fulgent COVID-19 by RT-PCR Test/Expanded to allow consumer-initiated SARS-CoV-2 testing with Picture Genetics’ COVID-19 Home Collection Kit |
| May 15 | One Health Laboratories | SARS-CoV-2 Real-Time RT-PCR Test |
| May 13, July 31 | Applied DNA Sciences | Linea COVID-19 RT-PCR test; expanded to include use of robotic RNA extraction |
| May 12 | Thermo Fisher Scientific | Expansion of EUA for Applied Biosystems TaqPath COVID-19 Combo Kit for use with new PCR instruments and reagents |
| May 11 | Columbia University | Triplex CII-SARS-CoV-2 rRT-PCR test |
| May 11 | 1drop Inc. | 1copy COVID-19 qPCR Multi Kit |
| May 11/Dec 23 | Abbott Molecular Inc. | Alinity m SARS-CoV-2 IgG serology blood test run on firm’s Alinity I next generation immunoassay system (s)/Reissued to allow use on pooled samples and for asymptomatic screening |
| May 8 | Biocollections Worldwide | RT-PCR test detecting N gene of SARS-CoV-2 virus |
| May 8 | Quidel | Sofia 2 SARS Antigen FIA rapid point-of-care test (a) |
| May 8 | Gnomegen | Gnomegen COVID-19-RT-qPCR Detection Kit |
| May 7 | BioMérieux | SARS-CoV-2 R-Gene test kit |
| May 7 | Opti Medical Systems | Opti SARS-CoV-2 RT-PCR kit |
| May 7 | Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics - Rutgers University | Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-Assay |
| May 7 | Zymo Research Corp. | Quick SARS-CoV-2rRT-PCR Kit |
| May 7 | Sherlock Biosciences | Sherlock CRISPR SARS-CoV-2 kit |
| May 6 | OPTI Medical Systems, Inc. | OPTI SARS-CoV-2 RT PCR Test |
| May 5 | University of Tennessee Health Science Center | UTHSC/UCH SARS-CoV-2 RT-PCR test |
| May 5 | Sansure Biotech | Novel Coronavirus Nucleic Acid Diagnostic Kit |
| May 5 | Siemens Healthineers | FTD SARS-CoV-2 test |
| May 4 | Euroimmun | Anti-SARS-CoV-2 ELISA test (s) |
| May 3 | Roche | Elecsys Anti-SARS-CoV-2 antibody test (s) |
| May 1 | Bio-Rad Laboratories | 2019-nCoV CDC ddPCR Triplex Probe Assay for use on firm’s QX200 and QXDx Droplet Digital PCR systems |
| April 30 | NY State Department of Health’s Wadsworth Center | New York SARS-CoV Microsphere Immunoassay for Antibody Detection (s) |
| April 30 | Altru Diagnostics | SARS-CoV-2 Test using Thermo Fisher Scientific’s TaqMan 2019-nCoV Assay Kit v1 |
| April 30 | BioFire Defense | BioFire COVID-19 Test(m) |
| April 30 | Biocerna | PCR-based SARS-CoV-2 assay |
| Apr 30/Dec 4 | Rheonix | Rheonix COVID-19 MDx assay/Reissued to allow use on saliva samples |
| April 28 | LabGenomics | LabGun COVID-19 RT-PCR Kit detecting RdRp and E genes of SARS-CoV-2 virus |
| April 27 | Bio-Rad Laboratories | Platelia Total Ab immunoassay for SARS-CoV-2 (s) |
| April 27 | Seasun Biomaterials | U-TOP COVID-19 Detection Kit uses dual-labeled peptide nucleic acid probes detecting 2 regions in ORF1ab and one region in N gene of SARS-CoV-2 |
| April 27 | Nationwide Children’s Hospital | SARS-CoV-2 assay, a modified version of CDC 2019-nCoV Real-Time RT-PCR assay |
| April 26 | DiaSorin | Liaison SARS-CoV-2 S1/S2 IgG serology assay detecting IgG antibodies in people who’ve been infected (s) |
| April 24 | MicroGenDx | COVID-19 Key assay detecting multiple sequences of SARS-CoV-2 N gene |
| April 24 | AIT Laboratories | SARS-CoV-2 Test detecting Orf1ab, N and S regions of virus’ single-stranded RNA genome |
| April 24 | Ultimate Dx | UDX SARS-CoV-2 Molecular Assay |
| April 24 | Ortho Clinical Diagnostics | SARS-CoV-2 immunoassay (s) |
| April 23 | SD Biosensor | Standard M nCoV Real-Time Detection kit |
| April 23 | Altona Diagnostics | RealStar SARS-CoV-2 RT-PCR Kit US |
| April 23 | Diatherix Eurofins | SARS-CoV-2 Assay |
| April 23 | Abbott Laboratories | SARS-CoV-2 IgG antibody test qualitatively detecting IgG antibodies in human serum (s) |
| April 22 | Mayo Clinic | PCR-based SARS-CoV-2 Molecular Detection Assay |
| April 22, July 30 | Seegene | PCR-based Allplex 2019-nCoV Assay; expanded to include use on more instruments |
| April 22 | Mobidiag | Novodiag PCR-based COVID-19 test |
| April 20 | Trax Management Services | PCR-based SARS-CoV-2 test |
| April 20 | Osang Healthcare | GeneFinder COVID-19 Plus RealAmp Kit |
| April 20 | Shanghai Fosun Pharmaceutical | COVID-19 RT-PCR test |
| April 20 | Exact Sciences | SARS-CoV-2 RT-PCR test; expanded for home collection |
| April 17 | GenoSensor | GS COVID-19 RT-PCR kit |
| April 17 | KorvaLabs | Curative-Korva SARS-Cov-2 Assay |
| April 16 | CirrusDx Laboratory | Assay detecting SARS-CoV-2 nucleocapsid gene |
| April 16 | Hackensack University Medical Center | CDI Enhanced COVID-19 test |
| April 16 | Maccura Biotechnology | Fluorescent PCR-based SARS-CoV-2 test kit |
| April 16 | Mount Sinai Laboratory | COVID-19 ELISA IgG Antibody Test (s) |
| April 15 | Boston Children’s Hospital | Childrens-Altona-SARS-CoV-2 assay |
| April 15 | Ortho Clinical Diagnostics | Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators (s) |
| April 14 | Baptist Hospital Miami | Probe-based real-time RT-PCR assay detecting the CDC N2 target |
| April 14 | Integrity Labs | Probe-based molecular test for SARS-CoV-2 detecting N1 and N2 targets from CDC Prevention assay kit |
| April 13 | Orig3n | Novel Coronavirus Test for qualitative detection of two regions in SARS-CoV-2 nucleocapsid gene |
| April 13 | Specialty Diagnostic Laboratories | Test for qualitative detection of a region in SARS-CoV-2 ORF1a/b gene |
| April 13 | Atila Biosystems | iAMP COVID-19 Detection Kit |
| April 13 | University of North Carolina Medical Center | UNC Health SARS-CoV-2 real-time RT-PCR test |
| April 13 | Rutgers Clinical Genomics Laboratory | First approved molecular COVID-19 test for use with saliva samples |
| April 9 | DiaCarta | QuantiVirus PCR diagnostic (Dx) test for COVID-19 |
| Apr 9/Nov 30 | Stanford Health Care Clinical Virology Laboratory | SARS-CoV-2 assay/Reissued to allow use with self-collected nasal swab samples |
| April 8 | Becton Dickinson | BD MAX ExK TNA-3 kit run on the BD Max system |
| April 8 | InBios International | Smart Detect SARS-CoV-2 rRT-PCR Kit |
| Apr 8/Dec 28 | Viracor Eurofins Clinical Diagnostics | Viracor SARS-CoV-2 molecular assay/Reissued to allow home collection and use on pooled samples |
| April 7 | Gnomegen | COVID-19 RT-Digital PCR Detection kit for diagnosing SARS-CoV-2 |
| April 6 | Diagnostic Molecular Laboratory at Northwestern Medicine | SARS-CoV-2 Assay |
| April 6 | Infectious Disease Diagnostics Laboratory at Children’s Hospital of Philadelphia | SARS-CoV-2 RT-PCR Test |
| April 6 | Massachusetts General Hospital | MGH SARS-CoV-2 assay |
| April 6 | Luminex | Aries SARS-CoV-2 Assay |
| April 6 | Co-Diagnostics | Logix Smart Coronavirus COVID-19 Test |
| April 6 | ScienCell Research Laboratories | ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR Detection Kit |
| April 3 | Becton Dickinson + BioGX | Sample-Ready hospital SARS-CoV-2 assay for use on BD Max system |
| April 2 | Ipsum Diagnostics | COV-19 IDx, an RT-PCR-based SARS-CoV-2 test |
| April 2 | Cellex | qSARS-CoV-2 IgG/IgM Rapid Test (s) |
| April 1 | Yale New Haven Hospital Clinical Virology Laboratory | SARS-CoV-2 RT-PCR test |
| March 30 | NeuMoDxt | NeuMoDx SARS-CoV-2 Test Strip for use on NeuMoDx 288 Molecular + NeuMoDx 96 Molecular systems |
| March 30 | Qiagen | QiaStat-Dx Respiratory SARS-CoV-2 Panel, first “syndromic” testing product to be deployed in US(m) |
| March 27 | Abbott | SARS-CoV-2 point-of-care test |
| March 27 | Luminex | NxTag CoV Extended Panel |
| March 27 | BGI Americas (BGI Genomics US sub) | BGI Real-Time Fluorescent RT-PCR Kit |
| March 25 | Quidel | Expanded EUA for Lyra SARS-CoV-2 assay |
| Mar 24/Dec 8 | BioMérieux | BioFire COVID-19 test run on firm’s BioFire FilmArray system/Reissued to allow use on pooled samples |
| March 24 | Mesa Biotech | Accula SARS-CoV-2 test |
| March 23 | Primerdesign | COVID-19 Genesig Real-Time PCR assay |
| March 21 | Cepheid | Xpert Xpress SARS-CoV-2 point-of-care test |
| March 20 | DiaSorin Molecular | Simplexa COVID-19 Direct assay run on firm’s Liason MDX real-time PCR instrument |
| March 19 | GenMark Diagnostics | ePlex SARS-CoV-2 Test run on firm’s ePlex system |
| Mar 19/Nov 13 | Quest Diagnostics | SARS-CoV-2 rRT PCR test/Reissued to allow home collection and testing on pooled samples |
| March 18 | Abbott | Abbott RealTime SARS-CoV-2 EUA run on firm’s PCR-based m2000 RealTime System |
| March 17 | Quidel | Lyra SARS-CoV-2, RT-qPCR assay for qualitative detection of nucleic acid from SARS-CoV-2 |
| March 16/Sept 23 | Hologic | Panther Fusion SARS-CoV-2 assay for use on firm’s Panther Fusion system; expanded for pooling + asymptomatic testing |
| March 16 / April 21 / July 24 | LabCorp | COVID-19 RT-PCR test; reissued as test using at-home self-collection; reissued for use on asymptomatic patients and for sample pooling |
| Mar 15/Dec 22 | Thermo Fisher Scientific | TaqPath COVID-19 Combo Kit for qualitative detection of SARS-CoV-2 nucleic acid/Reissued to allow home collection |
| Mar 13/Nov25 | Roche | Cobas SARS-CoV-2 Test/Reissued to allow use on pooled samples |
| March 2 | New York State | Wadsworth Center, New York State Department of Public Health’s New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel |
| Feb 4/Dec 1 | CDC | 2019 Real Time RT-PCR Diagnostic Test Panel/Reissued to allow use on pooled samples |
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