Company/Organization
Name | Test Name | US Regulatory Status* | EU Regulatory Status | Asia Regulatory Status | Technology |
| 1drop | 1copy COVID-19 qPCR Multi Kit | EUA 5/11/2020 | | | PCR |
| 3B Blackbio Biotech India (Kilpest India subsidiary) | TRUPCR SARS-CoV-2 Kit | EUA 6/18/2020 | | | PCR |
| 3D Medicines | SARS-CoV-2 and Influenza A & B RT-qPCR Detection Kit | | CE mark 3/2020 | | PCR |
| Abbott | SARS-CoV-2 IgG test | EUA 4/26/2020, amended 5/9/2020 | | | Serological |
| Abbott | ID Now COVID-19 | EUA 3/27/2020 | | | isothermal amplification |
| Abbott | Abbott RealTime SARS-CoV-2 EUA test | EUA 3/18/2020 | | | PCR |
| Access Bio | CareStart COVID-19 IgM/IgG | EUA 7/24/2020 | | | Serological |
| Access Bio | CareStart COVID-19 MDx RT-PCR | EUA 7/7/2020 | | | PCR |
| Access Genetics | OraRisk COVID-19 RT-PCR | EUA 7/17/2020 | | | PCR |
| Acupath Laboratories | Acupath COVID-19 Real-Time (RT-PCR) Assay | EUA 6/29/2020 | | | PCR |
| ADS Biotec | SARS-CoV-2 IgM/IgG Antibody Test Kit | EUA 6/18/2020 | CE mark 3/2020 | | Serological |
| Advanced Biological Laboratories | UltraGene Combo2Screen SARS-CoV-2 assay | | CE mark 5/2020 | | PCR |
| AIT Laboratories | SARS-CoV-2 Assay | EUA 4/24/2020 | | | PCR |
| Akston Biosciences | AntiCoV-ID IgG ELISA | EUA submission pending | | | Serological |
| ALPCO (American Laboratory Products Company) | ALPCO SARS-CoV-2 IgG Chemiluminescence ELISA | EUA submission pending | | | Serological |
| ALPCO (American Laboratory Products Company) | ALPCO SARS-CoV-2 IgM Chemiluminescence ELISA | EUA submission pending | | | Serological |
| ALPCO (American Laboratory Products Company) | ALPCO SARS-CoV-2 IgG ELISA | EUA submission pending | | | Serological |
| ALPCO (American Laboratory Products Company) | ALPCO SARS-CoV-2 IgM ELISA | EUA submission pending | | | Serological |
| Altru Diagnostics | Altru Dx SARS-CoV-2 RT-PCR assay | EUA 4/30/2020 | | | PCR |
| Altona Diagnostics | RealStar SARS-CoV-2 RT-PCR Kits (1.0 and U.S versions) | EUA 4/22/2020 | CE mark 4/2020 | | PCR |
| Anatolia Geneworks | Bosphore Novel Coronavirus (2019-nCoV) Detection Kit | | CE mark 2/2020 | | PCR |
| Applied BioCode | BioCode SARS-CoV-2 Assay | EUA 6/15/2020 | | | PCR |
| Applied DNA Sciences | Linea COVID-19 RT-PCR test | EUA 5/13/2020 | | | PCR |
| ArcDia International | MariPOC COVID-19 test | | CE mark 5/2020 | | Antigen |
| Aspirus Reference Laboratory | Aspirus SARS-CoV rRT-PCR Assay | EUA 6/1/2020 | | | PCR |
| Assurance Scientific Laboratories | Assurance SARS-CoV-2 Panel | EUA 5/15/2020 | | | PCR |
| Assure Tech (Hangzhou Co.) | Assure COVID-19 IgG/IgM Rapid Test Device | EUA 7/6/2020 | | | Serological |
| A*STAR,Tan Tock Seng Hospital of Singapore | A*STAR Fortitude 2.0 | | | Singapore Health Sciences Authority provisional authorization | PCR |
| Atila BioSystems | iAMP COVID-19 Detection Kit | EUA 4/10/2020 | | | Isothermal amplification |
| AusDiagnostics | AusDiagnostics SARS-CoV-2, influenza, RSV panel | | CE mark 3/2020 | | PCR |
| Autobio Diagnostics | Anti-SARS-CoV-2 Rapid Test | EUA 4/24/2020 | CE mark | | Serological |
| Avellino Lab | Avellino SARS-CoV-2/COVID-19 (AvellinoCoV2) | EUA 3/25/2020 | | | PCR |
| Avera Institute for Human Genetics | Avera Institute for Human Genetics SARS-CoV-2 Assay | EUA 5/22/2020 | | | PCR |
| Babson Diagnostics | Babson Diagnostics aC19G1 | EUA 6/23/2020 | | | Serological |
| BAG Diagnostics | Viro-Q SARS-CoV-2 kit | | CE mark 4/2020 | | PCR |
| Bako Diagnostics | BakoDx SARS-CoV-2 RNA test | EUA submission pending | | | PCR |
| Baptist Hospital Miami Pathology/Laboratory Medicine Lab | COVID-19 RT-PCR Test | EUA 4/13/2020 | | | PCR |
| Beckman Coulter | Access SARS-CoV-2 IgG | EUA 6/26/2020 | CE mark 6/2020 | | Serological |
| Becton Dickinson | BD Veritor System for Rapid Detection of SARS-CoV-2 | EUA 7/2/2020 | | | Antigen |
| Becton Dickinson | BD SARS-CoV-2 Reagents for BD MAX System | EUA 4/8/2020 | | | PCR |
| Becton Dickinson, BioGx | BioGX SARS-CoV-2 Reagents for the BD MAX System | EUA 4/2/2020 | | | PCR |
| Beijing Wantai Biological Pharmacy Enterprise Company | Wantai SARS-CoV-2 Ab Rapid Test | EUA 7/10/2020 | | | Serological |
| Beroni Group | SARS-CoV-2 IgG/IgM Antibody Detection Kit | | CE mark 4/2020 | | Serological |
| BGI | Real-Time Fluorescent RT-PCR kit for detecting SARS-2019-nCoV | EUA 3/26/2020 | CE mark 3/2/2020 | China NMPA 1/2020 | PCR |
| Biocerna | SARS-CoV-2 Test | EUA 4/28/2020 | | | PCR |
| Biocollections Worldwide | Biocollections Worldwide SARS-Co-V-2 Assay | EUA 5/7/2020 | | | PCR |
| BioCore | BioCore 20019-nCoV Real Time PCR Kit | EUA 5/21/2020 | | | PCR |
| Biodesix | SARS-CoV-2 Droplet Digital PCR (ddPCR) test | EUA submission pending | | | PCR |
| Biohit Healthcare (Hefei) | Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit | EUA 6/18/2020 | | | Serological |
| Biolidics | 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold) | EUA submission pending | CE mark 4/2020 | Singapore Health Sciences Authority provisional authorization; Philippines FDA | Serological |
| BioMedomics | COVID-19 IgM-IgG Rapid Test | | CE mark 3/2020 | | Serological |
| Biomerica | COVID-19 IgG/IgM Rapid Test | | CE mark 5/2020 | | Serological |
| BioMrieux | Vidas anti-SARS-CoV-2 IgM test | | CE mark 5/2020 | | Serological |
| BioMrieux | Vidas anti-SARS-CoV-2 IgG test | | CE mark 5/2020 | | Serological |
| BioMrieux | SARS-COV-2 R-GENE test | EUA 5/6/2020 | CE mark 4/10/2020 | | PCR |
| BioMrieux/BioFire Defense | BioFire COVID-19 test | EUA 3/23/2020 | | | PCR |
| BioMrieux/BioFire Diagnostics | BioFire Respiratory Panel 2.1 (RP2.1) (EUA) BioFire Respiratory Panel 2.1 plus (CE mark) | EUA 5/1/2020 | CE mark 7/2020 | | PCR |
| Bioneer | AccuPower COVID-19 Real-Time RT-PCR Kit, AccuPower SARS-CoV-2 Real-Time RT-PCR Kit | | CE mark | | PCR |
| Biopanda Reagents | COVID-19 Rapid Antibody Test | | CE mark 3/2020 | | Serological |
| Bio-Rad Laboratories | Bio-Rad SARS-CoV-2 ddPCR Test | EUA 5/1/2020 | | | PCR |
| Bio-Rad Laboratories | Platelia SARS-CoV-2 Total Ab assay | EUA 4/29/2020 | | | Serological |
| BioReference Laboratories | Novel Coronavirus COVID-19 | EUA submission pending | | | PCR |
| BioSewoon | Real-Q 2019-nCoV Detection Kit | EUA 7/9/2020 | | | PCR |
| Boston Children's Hospital Infectious Diseases Diagnostic Laboratory (IDDL) | Childrens-Altona-SARS-CoV-2 assay | EUA 4/14/2020 | | | PCR |
| Boston Heart Diagnostics | Boston Heart COVID-19 RT-PCR Test | EUA 7/16/2020 | | | PCR |
| Boston Medical Center | BMC-CReM COVID-19 Test | EUA 7/10/2020 | | | PCR |
| Broad Institute Clinical Research Sequencing Platform (CRSP) | CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay | EUA 7/8/2020 | | | PCR |
| Bruker | FluoroType SARS-CoV-2 plus | | CE mark 5/5/2020 | | PCR |
| Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine | SARS-CoV-2-Assay | EUA 5/13/2020 | | | PCR |
| Cellex | qSARS-CoV-2 IgG/IgM Rapid Test | EUA 4/1/2020 | | | Serological |
| Centers for Disease Control and Prevention | CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (CDC) | EUA 2/4/2020, amended 3/15/2020 | | | PCR |
| Centers for Disease Control and Prevention | Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay | EUA 7/2/2020 | | | PCR |
| Centogene | SARS-CoV-2 RT-PCR test | EUA 7/1/2020 | | | PCR |
| Cepheid | Xpert Xpress SARS-CoV-2 test | EUA 3/20/2020 | | | PCR |
| CerTest BioTec | ViaSure SARS-CoV-2 Real Time PCR Detection Kit | | CE mark 3/2020 on the Becton Dickinson BD Max system | | PCR |
| Chembio Diagnostics | DDP COVID-19 IgM/IgG System | EUA 4/14/2020 EUA revoked 6/16/2020 | | | Serological |
| Children's Hospital of Philadelphia Infectious Disease Diagnostics Laboratory | SARS-CoV-2 RT-PCR test | EUA 4/2/2020 | | | PCR |
| ChromaCode | HDPCR SARS-CoV-2 real-time PCR assay | EUA 6/9/2020 | | | PCR |
| CirrusDx Laboratories | CirrusDx SARS-CoV-2 Assay | EUA 4/15/2020 | | | PCR |
| Co-Diagnostics | Logix Smart Coronavirus Disease 2019 (COVID-19) Kit | EUA 4/3/2020 | CE mark 2/2020 | | PCR |
| Color | Color SARS-CoV-2 LAMP Diagnostic Assay | EUA 5/18/2020, amended 7/24/2020 | | | Isothermal amplification |
| Columbia University Laboratory of Personalized Genomic Medicine | Triplex CII-CoV-1 rRT-PCR Test | EUA 5/12/2020 | | | PCR |
| Compass Laboratory Services | Compass Laboratory Services SARS-CoV2 Assay | EUA 7/13/2020 | | | PCR, Home Collection |
| Cormeum Laboratory Services | Cormeum SARS-CoV-2 Assay | EUA 6/12/2020 | | | PCR |
| CoWin Biotech | Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing) | EUA 7/24/2020 | | | PCR |
| Credo Diagnostics Biomedical | VitaPCR SARS-CoV2 Assay | | CE mark 3/2020 | Singapore Health Sciences Authority provisional authorization | PCR |
| CSI Laboratories | CSI SARS-CoV-2 RT PCR Test | EUA 6/1/2020 | | | PCR |
| CTK Biotech | OnSite COVID-19 IgG/IgM Rapid Test | EUA submission pending | CE mark Q1/2020 | | Serological |
| CTK Biotech | Aridia COVID-19 PCR Test | | CE mark Q2/2020 | | |
| Cue Health | Cue COVID-19 Test | EUA 6/10/2020 | | | PCR |
| Dba SpectronRx | Hymon SARS-CoV-2 Test Kit | EUA 5/22/2020 | | | PCR |
| DiaCarta | QuantiVirus SARS-CoV-2 Multiplex Test Kit | EUA 7/21/2020 | | | PCR |
| DiaCarta | QuantiVirus SARS-CoV-2 test kit | EUA 4/8/2020 | CE mark 3/2020 | | PCR |
| Diagnostics Development Hub | Fortitude Kit 2.0E | | | Singapore Health Sciences Authority provisional authorization 2/2020 | PCR |
| Diagnostic Solutions Laboratory | DSL COVID-19 Assay | EUA 6/25/2020 | | | PCR |
| DiaSorin | Liaison SARS-CoV-2 S1/S2 IgG | EUA 4/24/2020 | CE mark 4/2020 | | Serological |
| DiaSorin Molecular | Simplexa COVID-19 Direct | EUA 3/19/2020 | CE mark 4/2020 | | PCR |
| Diatherix Eurofins Laboratory | SARS-CoV-2 PCR Test | EUA 4/22/2020 | | | PCR |
| Diazyme Laboratories | Diazyme DZ-Lite SARS-CoV-2 IgG CLIA kit | EUA 7/8/2020 | | | Serological |
| Emory Medical Laboratories | SARS-CoV-2 RBD IgG test | EUA 6/15/2020 | | | Serological |
| Enzo Biochem | Genflex Molecular Diagnostic Modular System (for SARS-CoV-2 Detection) | EUA submission pending | | | PCR |
| Enzo Biochem | SARS-CoV-2 IgG ELISA assay kit | EUA submission pending | | | Serological |
| Enzo Biochem/Enzo Life Sciences | Ampiprobe SARS-CoV-2 Test System | EUA 7/7/2020 | | | PCR |
| Erba Mannheim | ErbaLisa COVID-19 IgM ELISA | | CE mark 4/2020 | | Serological |
| Erba Mannheim | ErbaLisa COVID-19 IgG ELISA | EUA submission pending | CE mark 4/2020 | | Serological |
| Eurofins Ingenasa | Ingezim COVID 19 DR | | CE mark 6/2020 | | Serological |
| Euroimmun/PerkinElmer | Anti-SARS-CoV-2 ELISA (IgG) | EUA 5/4/2020 | | | Serological |
| Euroimmun/PerkinElmer | EuroRealTime SARS-CoV-2 | EUA 6/8/2020 | CE mark 3/2020 | | PCR |
| Euroimmun/PerkinElmer | Anti-SARS-CoV-2 ELISAs (IgA and IgG) | | CE mark 3/2020 | | Serological |
| Everlywell | Everlywell COVID-19 Test Home Collection Kit | EUA 5/15/2020 | | | Home collection kit |
| Exact Sciences | Exact Sciences SARS-CoV-2 (N gene detection) Test | EUA 5/22/2020 | | | PCR |
| Exact Sciences | SARS-CoV-2 Test | EUA 4/14/2020 | | | PCR |
| Express Gene (dba Molecular Diagnostics Laboratory) | Express Gene 2019-nCoV RT-PCR Diagnostic Panel | EUA 5/22/2020 | | | PCR |
| Fluidigm | Advanta Dx SARS-CoV-2 RT-PCR Assay | EUA submission pending | | | PCR |
| Fosun Pharma USA | Fosun COVID-19 RT-PCR Detection Kit | EUA 4/17/2020 | | | PCR |
| Fulgent Genetics/Fulgent Therapeutics | Fulgent COVID-19 by RT-PCR Test | EUA 5/15/2020 | | | PCR |
| Fulgent Genetics/MedScan Laboratory | COVID-19 | EUA submission pending | | | Sequencing |
| Genalyte | Maverick SARS-CoV-2 Multi-Antigen Serology Panel | EUA submission pending | | | Serological |
| Gencurix | GenePro SARS-CoV-2 Test | EUA 6/23/2020 | | | PCR |
| Gene By Gene | Gene By Gene SARS-CoV-2 Detection Test | EUA 7/7/2020 | | | PCR |
| Genedrive | Genedrive 96 SARS-CoV-2 Kit | EUA submissiong pending | CE mark 5/2020 | | PCR |
| GeneMatrix | NeoPlex COVID-19 Detection Kit | EUA 5/14/2020 | | | PCR |
| General Biologicals | GB SARS-CoV-2 Real-Time RT-PCR | | CE mark 4/2020 | Taiwan FDA approval; India Central Drugs Standard Control Organisation approval | PCR |
| GeneStore France | Detection Expert SARS-Cov-2 RT-PCR Test | | CE mark 4/2020 | | PCR |
| Genetic Signatures | EasyScreen SARS-CoV-2 detection kit | | CE mark 3/2020 | | PCR |
| Genetron | Genetron SARS-CoV-2 RNA Test | EUA 6/5/2020 | CE mark 4/2020 | | PCR |
| GenMark Diagnostics | ePlex SARS-CoV-2 Test | EUA 3/19/2020 | | | PCR |
| Genomica/PharmMar Group | 2 kits: qCOVID-19, CLART COVID-19 | | CE mark 3/2020 | | PCR |
| GenScript Biotech | cPass SARS-CoV-2 Neutralization Antibody Detection Kit | EUA submission pending | CE mark 5/2020 | | Serological |
| GenoSensor | GS COVID-19 RT-PCR Kit | EUA 4/16/2020 | | | PCR |
| Gnome Diagnostics | GnomeDX RT-PCR COVID-19 Test | EUA submission pending | | | PCR |
| Gnomegen | Gnomegen COVID-19-RT-qPCR Detection Kit | EUA 5/8/2020 | | | PCR |
| Gnomegen | Gnomegen COVID-19 RT-Digital PCR Detection Kit | EUA 4/6/2020 | | | PCR |
| Gold Standard Diagnostics/Eurofins Technologies | GSD NovaPrime SARS-CoV-2 (COVID-19) Real-Time PCR test | | CE mark 5/2020 | | PCR |
| Gold Standard Diagnostics/Eurofins Technologies | NovaLisa SARS-CoV-2 (US: GSD SARS-CoV-2) IgG, IgM, IgA assays | EUA submission pending | CE mark 4/2020 | | Serological |
| Gravity Diagnostics | Gravity Diagnostics COVID-19 Assay | EUA 6/1/2020 | | | PCR |
| Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory | CDI Enhanced COVID-19 Test | EUA 4/15/2020 | | | PCR |
| Hangzhou AllTest Biotech/Hangzhou Biotest Biotech | RightSign 2019-nCoV IgG/IgM Rapid Test Cassette | EUA 6/4/2020 | CE mark 2/2020 | | Serological |
| Healgen Scientific/Zhejiang Orient Gene Biotech | COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | EUA 5/29/2020 | | | Serological |
| HealthQuest Esoterics | HealthQuest Esoterics TaqPath SARS-CoV-2 Assay | EUA 6/23/2020 | | | PCR |
| Helix | Helix COVID-19 test | EUA 7/23/2020 | | | PCR |
| Hologic | Panther Fusion SARS-CoV-2 assay | EUA 3/16/2020 | | | PCR |
| Hologic | Aptima SARS-CoV-2 assay | EUA 5/14/2020 | | | PCR |
| Illumina | COVIDSeq Test | EUA 6/9/2020 | | | Sequencing |
| InBios International | SCoV-2 Detect IgG ELISA kit | EUA 6/10/2020 | | | Serological |
| InBios International | SCoV-2 Detect IgM ELISA kit | EUA 7/1/2020 | | | Serological |
| InBios International | Smart Detect SARS-CoV-2 rRT-PCR Kit | EUA 4/7/2020 | | | PCR |
| Inform Diagnostics | Inform Diagnostics SARS-CoV-2 RT-PCR Assay | EUA 6/26/2020 | | | PCR |
| Integrated DNA Technologies/Danaher | IDT 2019-novel coronavirus kit | under CDC's EUA | | | PCR |
| Integrity Laboratories | SARS-CoV-2 Assay | EUA 4/13/2020 | | | PCR |
| Ipsum Diagnostics | COV-19 IDx assay | EUA 4/1/2020 | | | PCR |
| Jiangsu Bioperfectus Technologies | COVID-19 Coronavirus Real Time PCR Kit | EUA 6/18/2020 | | | PCR |
| JN Medsys | ProTect Covid-19 kit | | CE mark 4/2020 | Singapore Health Sciences Authority provisional authorization; Philippines Food and Drug Administration | PCR |
| Kaiser Permanente Mid-Atlantic States | KPMAS COVID-19 Test | EUA 6/13/2020 | | | PCR |
| Kogene Biotech | PowerChek 2019-nCoV Real-time PCR Kit | EUA 7/13/2020 | CE mark | EUAL, Korea Centers for Disease Control and the Korea Food and Drug Administration | PCR |
| KorvaLabs | Curative-Korva SARS-Cov-2 Assay | EUA 4/16/2020 | | | PCR |
| Kroger Health | Kroger Health COVID-19 Test Home Collection Kit | EUA 6/30/2020 | | | Home collection kit |
| LabGenomics | LabGun COVID-19 RT-PCR Kit | EUA 4/29/2020 | | | PCR |
| Laboratorio Clinico Toledo | Laboratorio Clinico Toledo SARS-CoV-2 Assay | EUA 7/6/2020 | | | PCR |
| Laboratory Corporation of America | COVID-19 RT-PCR Test | EUA 3/16/2020, reissued 4/20/2020, amended 7/24/2020 | | | PCR |
| LetsGetChecked (PrivaPath Diagnostics) | LetsGetChecked Coronavirus (COVID-19) Test | EUA 5/28/2020 | | | PCR |
| LGC, Biosearch Technologies | 2019-nCoV CDC-qualified Probe and Primer Kits for SARS-CoV-2 | under CDC's EUA | | | PCR |
| LifeHope Labs | LifeHope2019-nCoV Real-Time RT-PCR Diagnostic Panel | EUA 6/29/2020 | | | PCR |
| Luminex | xMAP SARS-CoV-2 Multi-Antigen IgG Assay | EUA 7/16/2020 | | | Serological |
| Luminex | ARIES SARS-CoV-2 Assay | EUA 4/3/2020, amended 5/11/2020 | | | PCR |
| Luminex | NxTAGCoV Extended Panel Assay | EUA 3/27/2020 | | | PCR |
| Maccura Biotechnology | SARS-CoV-2 Fluorescent PCR Kit | EUA 4/15/2020 | | | PCR |
| Massachusetts General Hospital | MGH COVID-19 qPCR assay | EUA 4/3/2020 | | | PCR |
| Mayo Clinic Laboratories | SARS-CoV-2 Molecular Detection Assay | EUA 4/20/2020 | | | PCR |
| Mediagnost | Anti-SARS-CoV-2 ELISA | | CE mark 5/2020 | | Serological |
| MedMira | REVEALCOVID-19 total antibody test | EUA submission pending | CE mark 5/2020 | | Serological |