The list below is interactive: Sort by clicking on the column headings, or look for a specific test using the search box.
| Company Test name |
US Status | EU Status | Asia 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 | ||
| Abacus Diagnostica GenomEra SARS-CoV-2 Assay |
CE mark 7/2020 | PCR | ||
| Abbott SARS-CoV-2 IgG II Quant antibody test |
CE mark 12/2020 | Serological | ||
| Abbott AdviseDx SARS-CoV-2 IgM |
EUA 10/9/2020 | Serological | ||
| Abbott BinaxNOW COVID-19 Ag Card |
EUA 8/26/2020 | Antigen | ||
| 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 Antigen test |
EUA 10/8/2020 | Antigen | ||
| 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 | ||
| Acon Laboratories Acon SARS-Cov-2 IgG/IgM Rapid Test |
EUA 12/15/2020 | Serological | ||
| 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 | ||
| Aeon Global Health Aeon Global Health SARS-CoV-2 Assay |
EUA 9/30/2020 | PCR | ||
| AEP Alliance (Antaimmu Biomed, EirGenix, Panion & BF Biotech) Vstrip COVID-19 Antigen Rapid Test |
Taiwan Emergency Use Authorization 8/2020 | Antigen | ||
| Agena Bioscience MassArray SARS-CoV-2 Panel |
EUA 10/26/2020 | CE mark 9/2020 | Mass spectrometry | |
| AIT Laboratories SARS-CoV-2 Assay |
EUA 4/24/2020 | PCR | ||
| Akron Children's Hospital Akron Children's Hospital SARS-CoV-2 Assay |
EUA 9/29/2020 | PCR | ||
| Akston Biosciences AntiCoV-ID IgG ELISA |
EUA submission pending | Serological | ||
| Alimetrix Alimetrix SARS-CoV-2 RT-PCR Assay |
EUA 9/30/2020 | PCR, microarray | ||
| 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 | ||
| Alpha Genomix Laboratories Alpha Genomix TaqPath SARS-CoV-2 Combo Assay |
EUA 8/10/2020 | PCR | ||
| Altru Diagnostics Altru Dx SARS-CoV-2 RT-PCR assay |
EUA 4/30/2020 | PCR | ||
| Altona Diagnostics RealStar SARS-CoV02 RT-PCR Kits U.S. |
EUA 4/22/2020 | CE mark 4/2020 | PCR | |
| AMSBIO A+CheQ COVID-19 High-Speed RT-qPCR Detection Kit |
EUA submission pending | CE mark 7/2020 | Korea Ministry of Food and Drug Safety EUA 7/2020; Philippines FDA 9/2020 | PCR |
| Anatolia Geneworks Bosphore Novel Coronavirus (2019-nCoV) Detection Kit |
CE mark 2/2020 | PCR | ||
| AniCon Labor Kylt SARS-CoV-2 Complete RTU |
CE mark 6/2020 | PCR | ||
| Applied BioCode BioCode SARS-CoV-2 Assay |
EUA 6/15/2020 | PCR | ||
| Applied DNA Sciences Lniea 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 SAS-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 | PCR | ||
| 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; EUA revoked 8/6/2020 | 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 | ||
| BayCare Laboratories BayCare SARS-0CoV-2 RT PCR Assay |
EUA 8/31/2020 | PCR | ||
| Beckman Coulter Access SARS-CoV-2 IgM |
EUA 10/8/2020 | CE mark 11/2020 | Serological | |
| 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 COVID-19 daignostic test |
EUA 4/2/2020 | PCR | ||
| Beijing Wantai Biological Pharmacy Enterprise Wantai SARS-CoV-2 RT-PCR Kit |
EUA 9/9/2020 | PCR | ||
| Beijing Wantai Biological Pharmacy Enterprise Wantai SARS-CoV-2 Ab ELISA |
EUA 8/5/2020 | Serological | ||
| Beijing Wantai Biological Pharmacy Enterprise Wantai SARS-CoV-2 Ab Rapid Test |
EUA 7/10/2020 | Serological | ||
| Beroni Group SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) |
CE mark 12/2020 | Antigen | ||
| Beroni Group SARS-CoV-2 IgG/IgM Antibody Detection Kit |
CE mark 4/2020 | Serological | ||
| BGI (BGI PathoGenesis Pharmaceutical Technology) SARS-CoV-2 and Influenza A/B RT-PCR Kits |
CE mark 9/2020 | PCR | ||
| BGI Real-Time Fluorescent RT-PCR kit for detecting 2019-nCoV (SARS-CoV-2) |
EUA 3/26/2020 | CE mark 3/2/2020 | China NMPA 1/2020 | PCR |
| BillionToOne qSanger-COVID-19 Assay |
EUA 9/4/2020 | Sequencing | ||
| Binx Health Binx Health At-Home Nasal Swab COVID-19 Sample Collection Kit |
EUA 10/20/2020 | Collection kit | ||
| Biocan Diagnostics Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test |
EUA 8/25/2020 | Serological | ||
| Biocartis Idylla SARS-CoV-2 Test |
EUA submission pending | CE mark 11/2020 | PCR | |
| Biocerna SARS-CoV-2 Test |
EUA 4/28/2020 | PCR | ||
| Biocheck/Accelerate Diagnostics BioCheck SARS-CoV-2 IgM Antibody Test Kit |
EUA 9/9/2020 | Serological | ||
| Biocheck/Accelerate Diagnostics BioCheck SARS-CoV-2 IgG Antibody Test Kit |
EUA 9/9/2020 | Serological | ||
| Biocheck/Accelerate Diagnostics BioCheck SARS-CoV-2 IgM and IgG Combo Test |
EUA 8/17/2020 | Serological | ||
| Biocollections Worldwide Biocollections Worldwide SARS-Co-V-2 Assay |
EUA 5/7/2020 | PCR | ||
| BioCore BioCore 2019-nCoV Real Time PCR Kit |
EUA 5/21/2020 | PCR | ||
| Biodesix SARS-CoV-2 Droplet Digital PCR (ddPCR) test |
EUA submission pending | PCR | ||
| Bioeksen R&D Technologies Bio-Speedy Direct RT-qPCR SARS-CoV-2 |
EUA 9/2/2020 | PCR | ||
| BioGx Xfree COVID-19 Direct RT-PCR test |
EUA submission pending | PCR | ||
| Biohit Healthcare (Hefei) Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit |
EUA 6/18/2020 | Serological | ||
| BioMedomics COVID-19 IgM-IgG Rapid Test |
CE mark 3/2020 | Serological | ||
| Biomeme Biomeme SARS-CoV-2 Real-Time RT-PCR Test |
EUA 8/11/2020 | PCR | ||
| Biomerica COVID-19 IgG/IgM Rapid test |
CE mark 5/2020 | Serological | ||
| BioMérieux Vidas anti-SARS-CoV-2 IgM test |
EUA 8/6/2020 | CE mark 5/2020 | Serological | |
| BioMérieux Vidas anti-SARS-CoV-2 IgG test |
EUA 8/6/2020 | CE mark 5/2020 | Serological | |
| BioMérieux SARS-CoV-2 RESPI R-GENE test |
CE mark 12/2020 | PCR | ||
| BioMérieux SARS-COV-2 R-GENE test |
EUA 5/6/2020 | CE mark 4/10/2020 | PCR | |
| BioMérieux/BioFire Defense BioFire COVID-19 test |
EUA 3/23/2020, reissued 12/4/2020 | PCR | ||
| BioMérieux/BioFire Defense BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) |
EUA 10/2/2020 | PCR | ||
| BioMérieux/BioFire Defense BioFire Respiratory Panel 2.1 (RP2.1) (EUA); BioFire Resporatory Panel 2.1 plus (CE mark) |
EUA 5/1/2020 | CE mark 7/2020 | PCR | |
| Bioneer AccuPower RV1 Multiplex Kit |
CE mark 11/2020 | PCR | ||
| Bioneer AccuPower RV1 Real-Time RT-PCR Kit |
CE mark 11/2020 | 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 | CE mark 4/2020 | 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 Infecious Disease Diagnostic Laboratory (IDDL) Childrens-Altona-SARS-CoV-2 assay |
EUA 4/14/2020 | PCR | ||
| Boston Heart Diagnostics Boston Heart COVID-19 RT-PCE 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, reissued 10/23/2020 | PCR | ||
| Bruker FluoroType SARS-CoV-2/Flu/RSV panel |
CE mark 12/2020 | PCR | ||
| Bruker FluoroType SARS-CoV-2 plus |
CE mark 5/5/2020 | PCR | ||
| Capstone Healthcare Genus SARS-CoV-2 Assay |
EUA 8/3/2020 | 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 | ||
| Celltrion Sampinute COVID-19 Antigen MIA |
EUA 10/23/2020 | Antigen | ||
| 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, reissued 12/1/2020 | PCR | ||
| Centers for Disease Control and Prevention Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay |
EUA 7/2/2020 | PCR | ||
| Centogene CentoSure SARS-CoV-2 RT-PCR Assay |
EUA 9/29/2020 | PCR | ||
| Centogene SARS-CoV-2 RT-PCR test |
a href="https://www.fda.gov/media/139722/download">EUA 7/1/2020 | PCR | ||
| Cepheid Xpert Omni SARS-CoV-2 |
EUA 11/27/2020 | PCR | ||
| Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV test |
EUA 9/24/2020 | PCR | ||
| Cepheid Xpert Xpress SARS-CoV-2 test |
EUA 3/20/2020 | PCR | ||
| CerTest BioTec Viasure SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit |
CE mark 10/2020 on BD Max system | |||
| CerTest BioTec ViaSure SARS-CoV-2 Real Time PCR Detection Kit |
CE mark 3/2020 on 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 | ||
| Clear Labs Clear Dx SARS-CoV-2 |
EUA 9/23/2020 | Sequencing | ||
| Cleveland Clinic Robert J. Thomsich Pathology and Laboratory Medicine Intstitute Cleveland Clinic SARS-CoV- Assay |
EUA 8/3/2020 | PCR | ||
| Clinical Enterprise EmpowerDX At-Home COVID-19 PCR Test Kit |
EUA 10/15/2020 | Collection kit | ||
| Clinical Reference Laboratory CRL Rapid Response |
EUA 7/30/2020 | Molecular | ||
| Co-Diagnostics Logix Smart SARS-CoV-2 Multi-Gene Test |
CE mark 11/2020 | PCR | ||
| Co-Diagnostics Logix Smart ABC Assay |
CE mark 11/2020 | PCR | ||
| Co-Diagnostics Logix Smart Coronavirus COVID-19 |
4/3/2020 | CE mark 2/2020 | PCR | |
| Color Color COVID-19 Self-Swab Collection Kit |
EUA 8/31/2020 | Collection kit | ||
| Color Color SARS-CoV-2 LAMP Diagnostic assay |
EUA 5/18/2020, reissued 11/2/2020 | 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-Fluorscence Probing) |
EUA 7/24/2020 | PCR | ||
| Credo Diagnostics Biomedical VitaPCR Influenza A&B/SARS-CoV-2 assay |
CE mark 10/2020 | 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 |
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 | ||
| Cuur Diagnostics Cuur Diagnostics SARS-CoV-2 Molecular Assay |
EUA 8/26/2020 | PCR | ||
| Darwin Biosciences CoVLab |
EUA submission pending | PCR | ||
| Dba SpectronRx Hymon SARS-CoV-2 Test Kit |
EUA 5/22/2020 | PCR | ||
| Detectachem MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit |
EUA 9/1/2020 | Isothermal amplification | ||
| DiaCarta QuantiVirus SARS-CoV-2 Multiplex test kit |
EUA 7/21/2020 | PCR | ||
| DiaCarta QuantiVirus SARS-CoV-2 test |
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 COVID-19 Assay |
EUA 6/25/2020 | PCR | ||
| DiaSorin Liaison SARS-CoV-2 Ag |
CE mark 10/2020 | Antigen | ||
| DiaSorin Diasorin Liaison SARS-CoV-2 IgM Assay |
9/29/2020 | Serological | ||
| 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 COVID-19 Panel |
EUA 4/22/2020 | PCR | ||
| Diazyme Laboratories Diazyme DZ-LITE SARS-CoV-2 IgG, IgM CLIA Kits |
EUA 7/8/2020 | Serological | ||
| Diazyme Laboratories Diazyme DZ-Lite SARS-CoV-2 RT-PCR Test |
EUA 8/17/2020 | Serological | ||
| DNA Genotek/OraSure Technologies ORAcollect-RNA OR-100 and ORAcollect-RNA ORE-100 saliva collection devices |
EUA 10/28/2020 | Collection device | ||
| DNA Genotek/OraSure Technologies Omnigene-Orall OM-505 and OME-505 (Omnigene-Oral) saliva collection devices |
EUA 10/14/2020 | Collection device | ||
| DnaNudge COVID Nudge test |
CE mark 6/2020 | PCR | ||
| DNA-Technology Research & Production SARS-CoV-2/SARS-CoV Multiplex REAL-TIME PCR Detection Kit |
CE mark 4/2020 | PCR | ||
| DxTerity Diagnostics DxTerity SARS-CoV-2 RT PCR CE Test |
EUA 8/28/2020 | PCR | ||
| DxTerity Diagnostics DxTerity SARS-CoV-2 RT-PCR Test |
EUA 8/21/2020 | PCR | ||
| Eli Lilly Lilly SARS-CoV-2 Assay |
EUA 7/27/2020 | PCR | ||
| EliTech SARS-CoV-2 Plus ELITe MGB Assay |
EUA submission pending | PCR | ||
| Emory Medical Laboratories SARS-CoV-2 RBD IgG test |
EUA 6/15/2020 | Serological | ||
| Empirical Bioscience QuantiTase, QuantiTase Plus One Step RT-qPCR Kits |
EUA submission pending | PCR | ||
| Ender Diagnostics Ender Lab |
CE mark 6/2020 | PCR | ||
| Ender Diagnostics Ender Mass |
CE mark 8/2020 | isothermal amplification | ||
| 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 IgG ELISA |
CE mark 4/2020 | Serological | ||
| Erba Mannheim ErbaLisa COVID-19 IgM ELISA |
CE mark 4/2020 | Serological | ||
| Ethos Laboratories Ethose Laboratories SARS-CoV-2 MALDI-TOF Assay |
EUA 8/3/2020 | Mass spectrometry | ||
| Eurofins Ingenasa Ingezim COVID 19 DR |
CE mark 6/2020 | Serological | ||
| Euroimmun/PerkinElmer SARS-CoV-2 Antigen ELISA |
CE mark 12/2020 | Antigen | ||
| Euroimmun/PerkinElmer EuroRealTime SARS-CoV-2/Influenza A/B |
CE mark 12/2020 | PCR | ||
| Euroimmun/PerkinElmer EuroRealTime SARS-CoV-2 |
EUA 6/8/2020 | CE mark 3/2020 | PCR | |
| Euroimmun/PerkinElmer Anti-SARS-CoV-2 ELISA (IgG) |
EUA 5/4/2020 | Serological | ||
| 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, reissued 11/19/2020 | PCR | ||
| Fluidigm Advanta Dx SARS-CoV-2 RT-PCR Assay |
EUA 8/25/2020 | 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 10/8/2020 | 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 submission pending | CE mark 5/2020 | PCR | |
| GeneFirst GeneFirst COVID-19 Detection Kit |
CE mark 4/2020 | PCR | ||
| GeneFirst GeneFirst COVID-19 Plus Detection Kit |
CE mark 12/2020 | PCR | ||
| GeneMatrix NeoPlex COVID-19 Detection Kit |
EUA 5/14/2020 | PCR | ||
| General Biologicals GB SARS-CoV-2 Ab ELISA kit |
CE mark 8/2020 | Serological | ||
| 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 | |
| Genesprint SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) |
CE mark 9/2020 | Antigen | ||
| GeneStore France Detection Expert SARS-Cov-2 RT PCR Test |
CE mark 4/2020 | PCR | ||
| Genetic Signatures SARS-CoV-2 detection kit |
CE mark 3/2020 | PCR | ||
| Genetrack Biolabs Genetrack SARS-CoV-2 Molecular Assay |
EUA 9/25/2020 | PCR | ||
| Genetron Detection Kit for Novel Coronavirus (SARS-CoV-2) RNA (PCR-Fluorescence Probing) |
EUA 6/5/2020 | CE mark 4/2020 | PCR | |
| Genetworx Genetworx Covid-19 Nasal Swab Test |
EUA 12/15/2020 | PCR | ||
| GenMark Diagnostics ePlex Respiratory Pathogen Panel 2 (RP2) |
EUA 10/8/2020 | PCR | ||
| GenMark Diagnostics ePlex SARS-CoV-2 Test (discontinued) |
EUA 3/19/2020 | PCR | ||
| GenMark Diagnostics eSensor SARS-CoV-2 test |
EUA submission pending | 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 11/6/2020 | CE mark 5/2020 | Serological | |
| GenoSensor GS COVID-19 RT-PCR Kit |
EUA 4/16/2020 | PCR | ||
| George Washington University Public Health Laboratory GWU COVID-19 RT-PCR Test |
EUA 8/7/2020 | PCR | ||
| GK Pharmaceuticals Contract Manufacturing Operations GK Accu-Right SARS-CoV-2 RT-PCR Kit |
EUA 9/18/2020 | 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 NovaGen SARS-CoV-2 (COVID-19) antigen rapid test |
CE mark 12/2020 | Antigen | ||
| 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 |
CE mark 4/2020 | Serological | ||
| Gravity Diagnostics Gravity Diagnostics SARS-CoV-2 RT-PCR Assay |
EUA 11/23/2020 | PCR | ||
| Gravity Diagnostics Gravity Diagnostics COVID-19 Assay |
EUA 6/1/2020 | PCR | ||
| Grifols Procleix SARS-CoV-2 Assay |
CE mark 5/2020 | Isothermal amplification | ||
| Guardant Health Guardant-19 |
EUA 8/21/2020 | Sequencing | ||
| Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory CDI Enhanced COVID-19 Test |
EUA 4/15/2020 | PCR | ||
| Hai Kang Life C/Tech SARS-CoV-2 ERT-PCR kit |
CE mark 7/2020 | PCR | ||
| Hai Kang Life C/Tech SARS-CoV-2 RT-PCR kit |
CE mark 7/2020 | PCR | ||
| Hangzhou AllTest Biotech 2019-nCoV IgG/IgM Rapid Test Cassette |
EUA submission pending | CE mark 2/2020 | Serological | |
| Hangzhou Biotest Biotech RightSign COVID-19 IgG/IgM Rapid Test Cassette |
EUA 6/4/2020 | Serological | ||
| Hayat Genetics Hayat Rapid Colorimetric & Fluroimetric One Steop LAMP SARS-CoV-2 Test Kit |
CE mark 9/2020 | Isothermal amplification | ||
| Healgen Scientific 2019-nCoV Direct qPCR Kit |
CE mark 4/2020 | PCR | ||
| Healgen Scientific COVID-19 IgG/IgM Rapid Test Cassette |
CE mark 4/2020 | 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 NGS test |
EUA 8/6/2020, reissued 10/22/2020 | Sequencing | ||
| 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/Flu assay |
EUA 12/16/2020 | PCR | ||
| Hologic Aptima SARS-CoV-2 assay |
EUA 5/14/2020 | PCR | ||
| Illumina COVIDSeq Test |
EUA 6/9/2020 | Sequencing | ||
| Immundiagnostik IDK anti-SARS-CoV-2 IgG ELISA |
CE mark 5/2020 | Serological | ||
| Immundiagnostik MutaPLEX Coronavirus |
CE mark 4/2020 | PCR | ||
| InBios International CoV-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 | ||
| Innocreate Bioscience Innocreate SARS-CoV-2 QD kit |
Taiwan Food and Drug Administration approval | PCR | ||
| Innovita (Tangshan) Biological Technology Innovita 2019-nCoV Ab Test (Colloidal Gold) |
EUA 11/23/2020 | Serological | ||
| 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 COD-19 IDx assay |
EUA 4/1/2020 | PCR | ||
| Jiangsu Bioperfectus Technologies COVID-19 Coronavirus Real Time PCR Kit |
EUA 6/18/2020 | PCR | ||
| Jiangsu Well Biotech Orawell IgM/IgG Rapid Test |
EUA 9/23/2020 | Serological | ||
| JN Medsys ProTect Covid-19 kit |
Under CDC's EUA | 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 | ||
| Kantaro Biosciences COVID-SeoKlir COVID-SeroIndex quantitative SARS-CoV-2 IgG antibody test kits |
EUA 11/25/2020 (COVID-SeroKlir) | CE mark 10/2020 | Serological | |
| Kephera Diagnostics KDx SARS-CoV-2 IgG/IgM ELISA |
EUA submission pending | Serological | ||
| KimForest Enterprise KimForest SARS-CoV-2 Detection Kit v1 |
EUA 9/21/2020 | PCR | ||
| Kogene Biotech 2019 Novel Coronavirus 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 LabCorp 2019 Novel Coronavirus test |
EUA 3/16/2020, reissued 4/20/2020, 7/24/2020, 9/18/2020, 12/9/2020 | PCR | ||
| LetsGetChecked (PrivaPath Diagnostics) LetsGetChecked Coronavirus (COVID-19) Test |
EUA 5/28/2020 | PCR | ||
| LGC, Biosearch Technologies Biosearch Technologies SAR-CoV-2 Real-Time and End-Point RT-PCR Test |
EUA submission pending | 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 | ||
| Lucira Health Lucira COVID-19 All-In-One Test Kit |
EUA 11/17/2020 | LAMP | ||
| 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 | ||
| Luminostics Clip COVID Rapid Antigen Test |
EUA 12/7/2020 | Antigen | ||
| LumiraDx LumiraDx SARS-CoV-2 RNA STAR Complete |
EUA 10/14/2020 | PCR | ||
| LumiraDx LumiraDx SARS-CoV-2 Ag Test |
EUA 8/18/2020 | Antigen | ||
| LumiraDx LumiraDx SARS-CoV-2 RNA STAR |
EUA 8/11/2020 | PCR | ||
| Maccura Biotechnology SARS-CoV-2 Fluorescent PCR Kit |
EUA 4/15/2020 | PCR | ||
| Mammoth Biosciences SARS-CoV-2 DETECTR Reagent Kit |
EUA 8/31/2020 | |||
| Massachusetts General Hospital MGH COVID-19 qPCR assay |
EUA 4/3/2020 | PCR | ||
| MatMaCorp MatMaCorp COVID-19 2SF Test |
EUA 12/17/2020 | PCR | ||
| Mayo Clinic Laboratories SARS-CoV-2 Molecular Detection Assay |
EUA 4/20/20 | PCR | ||
| Mediagnost Anti-SARS-CoV-2 ELISA |
CE mark 5/2020 | Serological | ||
| MedMira REVEALCOVID019 total antibody test |
EUA submission pending | CE mark 5/2020 | Serological | |
| Megna Health Rapid COVID-19 IgM/IgG Combo Test Kit |
EUA 7/17/2020 | Serological | ||
| Meridian Bioscience Revogene SARS-CoV-2 test |
EUA submission pending | PCR | ||
| Mesa Biotech Accula SARS-CoV-2 test |
EUA 3/23/2020 | PCR | ||
| MicroGenDx (Southwest Regional PCR Laboratory) COVID-19 Key |
EUA 3/23/2020 | PCR | ||
| MiraDx MiraDx SARS-CoV-2 RT-PCR assay |
EUA 8/31/2020 | PCR | ||
| Mobidiag Novodiag COVID-19 |
CE mark 6/2020 | PCR | ||
| Mobidiag Amplidiag COVID-19 |
CE mark 6/2020 | PCR | ||
| Mount Sinai Labs COVID-19 ELISA IgG Antibody Test |
EUA 4/15/2020 | Serological | ||
| MP Biomedicals Asia Pacific Assure SARS-CoV-2 IgG/IgM rapid test |
Singapore Health Sciences Authority provisional authorization | Serological | ||
| Nal von minden Nadal COVID-19 IgG/IgM test |
CE mark 3/2020 | Serological | ||
| NanoEntek America Frend COVID-19 Total Ab |
EUA 9/29/2020 | Serological | ||
| National Jewish Health SARS-CoV-2 MassArray Test |
EUA 9/29/2020 | Serological | ||
| Nationwide Children's Hospital SARS-CoV-2 Assay |
EUA 4/27/2020 | PCR | ||
| Nebraska Medicine Clinical Laboratory NEcov19 RT-PCR Assay |
EUA 6/4/2020 | PCR | ||
| Neomedica Naissa SARS-CoV-2 IgM |
CE Mark 7/2020 | Serological | ||
| Neomedica Naissa SARS-CoV-2 IgG |
CE Mark 7/2020 | Serological | ||
| Neomedica Naissa SARS-CoV-2 IgA |
CE Mark 7/2020 | Serological | ||
| NeuMoDx Molecular NeuMoDx SARS-CoV-2 Assay |
EUA 3/30/2020 | CE mark 5/2020 | PCR | |
| NGeneBio NGenePlex nCoV qRT-PCR kit |
EUA submission pending | CE mark 7/2020 | PCR | |
| Nirmidas Biotech Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit |
EUA 9/29/2020 | Serological | ||
| Northwestern Medicine Diagnostic Molecular Laboratory SARS-Cov-2 Assay |
EUA 4/2/2020 | PCR | ||
| Novacyt/Primerdesign COVID-19 Genesig Real-Time PCR assay |
EUA 3/20/2020 | CE mark 2/2020 | EUA, India 3/26/2020, Thailand Ministry of Health, 4/2/2020 | PCR |
| NowDiagnostics AdexusDx COVID-19 Total Antibody Rapid Test |
CE mark 7/2020 | Serological | ||
| NY State Department of Health (performed at Wadsworth Center and New York City Department of Health and Mental Hygiene, Public Health Laboratories) New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel |
EUA 3/10/2020 | PCR | ||
| Ohio State University Wexner Medical Center OSUWMC COVID-19 RT-PCR test |
EUA 6/17/2020 | PCR | ||
| Omnipathology Solutions Medical Corporation Omni COVID-19 Assay by RT-PCR |
EUA 6/17/2020 | PCR | ||
| Omixon/SeqOnce Biosciences AzureSeq-200 RT-PCR kit |
CE mark 10/2020 | PCR | ||
| One Health Laboratories SARS-CoV-2 Real-Time RT-PCR-Test |
EUA 5/13/2020 | PCR | ||
| Operon Real SARS-CoV-1/2 kit |
CE mark 10/2020 | PCR | ||
| OpGen SARS-CoV-2 Kit with PULB |
CE mark 8/2020 | PCR | ||
| Opti Medical Systems Opti SARS-CoV-2 RT-PCR kit |
EUA 5/6/2020 | CE mark 6/2020 | PCR | |
| Optolane Technologies Kaira 2019-nCoV Detection kit |
EUA 9/1/2020 | CE mark 4/2020 | PCR | |
| Orig3n Orig3n 2019 Novel Coronavirus (COVID-19) Test |
EUA 4/10/2020 | PCR | ||
| Ortho Clinical Diagnostics Vitros SARS-CoV-2 Antigen test |
CE mark 10/2020 | Antigen | ||
| Ortho Clinical Diagnostics Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test |
CE mark 5/2020 | Serological | ||
| Ortho Clinical Diagnostics Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators |
EUA 4/14/2020, amended 5/9/2020 | CE mark 5/2020 | Serological | |
| Ortho Clinical Diagnostics Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack/Calibrator |
EUA 4/24/2020 | Serological | ||
| Osang Healthcare GeneFinder COVID-19 RealAmp Kit |
EUA 4/18/2020 | CE mark 2/2020 | PCR | |
| Oxford Nanopore Technologies LamPore |
CE mark 10/2020 | LAMP, sequencing | ||
| P23 Labs P23 Labs TaqPath SARS-CoV-2 Assay |
EUA 5/21/2020, reissued 10/20/2020 | PCR | ||
| PacificDx (ResearchDx) PacificDx Covid-19 Test |
EUA 12/11/2020 | PCR | ||
| PathoFinder RespiFinder 2Smart kit |
CE mark 11/2020 | PCR | ||
| PathoFinder RealAccurate Quadruplex (RAQ) Flu/COVID-19 PCR kit |
CE mark 11/2020 | PCR | ||
| PathoFinder RealAccurate Quadruplex Corona-plus PCR kit |
CE mark 4/2020 | PCR | ||
| PathoFinder RealAccurate Quadruplex SARS-CoV-2 PCR Kit |
CE mark 6/2020 | PCR | ||
| Patients Choice Laboratories PCL SARS-CoV-2 Real-Time RT-PCR Assay |
EUA 8/28/2020 | PCR | ||
| PerkinElmer PKamp Respiratory SARS-CoV-2 RT-PCR Panel |
CE mark 10/2020 | PCR | ||
| PerkinElmer SuperFlex Anti-SARS-CoV-2 IgG kit |
CE mark 7/2020 | Serological | ||
| PerkinElmer PerkinElmer GSP/DELFIA Anti-SARS-CoV-2 IgG kit |
CE mark 7/2020 | Serological | ||
| PerkinElmer PerkinElmer SARS-CoV-2 RT-PCR Assay |
CE mark 11/2020 | |||
| PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit |
CE mark 4/2020 | |||
| PerkinElmer PerkinElmer New Coronavirus Nucleic Acid Detection Kit |
EUA 3/24/2020, reissued 10/28/2020 | PCR | ||
| Phosphorus Diagnostics Phosphorous COVID-19 RT-qPCR Test |
EUA 6/4/2020 | PCR | ||
| PlexBio IntelliPlex SARS-CoV-2 Detection Kit |
EUA 6/25/2020 | CE mark 5/2020 | PCR | |
| Poplar Healthcare Poplar SARS-CoV-2 TMA Pooling assay |
EUA 8/3/2020 | isothermal amplification | ||
| PreciGenome FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR) |
EUA 6/25/2020 | PCR | ||
| Progenika Biopharma/Grifols Anti-SARS-CoV-2 (IgG) ELISA kit |
CE mark 9/2020 | Serological | ||
| Pro-Lab Diagnostics Pro-AmpRT SARS-CoV-2 Test |
EUA 8/13/2020 | isothermal amplification | ||
| ProterixBio SARS-CoV-2 (RBD) IgG Antibody test |
EUA submission pending | Serological | ||
| Psomagen Psoma COVID-19 RT Test |
EUA 6/30/2020 | PCR | ||
| QDx Pathology Services QDX SARS-CoV-2 Assay |
EUA 8/25/2020 | PCR | ||
| Qiagen QiaStat-Dx Respiratory SARS-CoV-2 Panel |
EUA 3/30/2020 | CE mark 3/2020 | PCR | |
| Quadrant Biosciences Clarifi COVID-19 Test Kit |
EUA 9/22/2020 | PCR | ||
| Quansys Biosciences Q-Plex SARS-CoV-2 Human IgG (4 Plex) |
EUA 10/28/2020 | Serological | ||
| QuantuMDx QuantuMDx SARS-CoV-2 RT-PCR Detection Assay |
EUA submission pending | CE mark 6/2020 | PCR | |
| Quest Diagnostics Infectious Disease Quest Diagnostics RC COVID-19+Flu RT-PCR |
EUA 12/4/2020 | PCR | ||
| Quest Diagnostics Infectious Disease Quest Diagnostics HA SARS-CoV-2 |
EUA 7/15/2020 | PCR | ||
| Quest Diagnostics Infectious Disease Quest Diagnostics RC SARS-CoV-2 Assay |
EUA 7/15/2020, reissued 11/27/2020 | PCR | ||
| Quest Diagnostics Infectious Disease Quest Diagnostics PF SARS-CoV-2 Assay |
EUA 7/15/2020 | PCR | ||
| Quest Diagnostics Coronavirus Disease 2019 (COVID-19) Test |
EUA 3/17/2020, reissued 7/18/2020 | PCR | ||
| Quidel QuickVue SARS Antigen test |
EUA 12/18/2020 | Antigen | ||
| Quidel Sofia 2 Flu + SARS Antigen FIA |
EUA 10/2/2020 | Antigen | ||
| Quidel Sofia 2 SARS Antigen FIA |
EUA 5/8/2020 | CE mark 7/2020 | Antigen | |
| Quidel Lyra SARS-CoV-2 Assay |
EUA 3/17/2020, amended 3/23/2020 | CE mark 3/2020 | PCR | |
| Quidel Lyra Direct SARS-CoV-2 Assay |
EUA 5/18/2020 | CE mark 5/2020 | PCR | |
| Quotient Limited/Quotient Suisse MosaiQ COVID-19 Antibody Microarray |
EUA 9/25/2020 | CE mark 5/2020 | Serological | |
| RapidRona RapidRona Self-Collection Kit |
EUA 11/23/2020 | Collection kit | ||
| R-Biopharm Rida Gene SARS-CoV-2 |
CE mark 5/2020 | PCR | ||
| Rendu Biotechnology 2019-nCoV detection kit |
China NMPA 3/2020 | isothermal amplification | ||
| Rheonix Rheonix COVID-19 MDx Assay |
EUA 4/29/2020 | PCR | ||
| Roche Cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test (for Cobas Liat system) |
EUA 9/14/2020 | PCR | ||
| Roche Cobas SARS-CoV-2 & Influenza A/B |
EUA 9/3/2020 | PCR | ||
| Roche Elecsys Anti-SARS-CoV-2 S |
EUA 11/25/2020 | Serological | ||
| Roche Elecsys Anti-SARS-CoV-2 |
EUA 5/2/2020 | Serological | ||
| Roche Cobas SARS-CoV-2 Test |
EUA 3/12/2020 | CE mark 2020 | PCR | |
| RTA Laboratories Diagnovital SARS CoV-2 Real-Time PCR Kit |
EUA 6/12/2020 | PCR | ||
| Rutgers University Clinical Genomics Laboratory ThermoFisher - Applied Biosystems TaqPath COVID-19 Combo Kit |
EUA 4/10/2020, amended 5/7/2020 | PCR | ||
| Salofa Sienna-Clarity Coviblock COVID-19 IgG/IgM Rapid Test Cassette |
EUA 7/13/2020 | Serological | ||
| Sandia National Laboratories SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay |
EUA 7/27/2020 | PCR | ||
| Sansure BioTech Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) |
EUA 5/4/2020 | PCR | ||
| ScienCell Research Laboratories ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit |
EUA 4/3/2020 | PCR | ||
| SD Biosensor Standard M nCoV Real-Time Detection Kit |
EUA 4/23/2020 | PCR | ||
| SD Biosensor Standard Q COVID-19 IgM/IgG Duo Test |
Serological | |||
| Seasun Biomaterials AQ-TOP COVID-19 Rapid Detection Kit Plus |
EUA 10/5/2020 | isothermal amplification | ||
| Seasun Biomaterials U-TOP COVID-19 Detection Kit |
EUA 4/27/2020 | PCR | ||
| Seasun Biomaterials AQ-TOP COVID-19 Rapid Detection Kit |
EUA 5/21/2020 | isothermal amplification | ||
| Seegene Allplex SARS-CoV-2/FluA/FluB/RSV Assay |
CE mark 9/2020 | PCR | ||
| Seegene Allplex 2019-nCoV Assay |
EUA 4/21/2020 | CE mark 2/2020 | EUA, Korea Ministry of Food and Drug Safety | PCR |
| Sentinel Diagnostics STAT-NAT COVID-19 HK kit, B kit |
CE mark 3/2020 | PCR | ||
| SeqOnce Biosciences AzureSeq SARS-CoV-2 RT-qPCR Kit |
EUA submission pending | PCR | ||
| Shanghai Fosun Long March Medical Science/Shanghai Fosun Pharmaceutical novel coronavirus nucleic acid detection kit |
CE mark 3/2020 | China NMPA 3/2020 | PCR | |
| Shenzhen New Industries Biomedical Engineering (SNIBE) Maglumi2019-nCoV IgM/IgG |
EUA 9/14/2020 | Serological | ||
| Sherlock Biosciences Sherlock CRISPR SARS-CoV-2 kit |
EUA 5/6/2020 | CRISPR | ||
| Siemens Healthineers SARS-CoV-2 IgG Antibody Test |
EUA submission pending | CE mark 11/2020 | Serological | |
| Siemens Healthineers Clinitest Rapid COVID-19 Antigen Test |
CE mark 10/2020 | Antigen | ||
| Siemens Healthineers Atellica IM SARS-CoV-2 Total (COV2T) |
EUA 5/29/2020 | CE mark 5/2020 | Serological | |
| Siemens Healthineers Atellica IM SARS-CoV-2 IgG (COV2G) |
EUA 7/31/2020 | Serological | ||
| Siemens Healthineers Advia Centaur SARS-CoV-2 Total (COV2T) |
EUA 5/29/2020 | CE mark 5/2020 | Serological | |
| Siemens Healthineers Advia Centaur SARS-CoV-2 IgG (COV2G) |
EUA 7/31/2020 | Serological | ||
| Siemens Healthineers Dimension EXL SARS-CoV-2 |
EUA 6/8/2020 | Serological | ||
| Siemens Healthineers Dimension Vista SARS-CoV-2 |
EUA 6/8/2020 | Serological | ||
| Siemens Healthineers/Fast Track Diagnostics Fast Track Diagnostics (FTD) SARS-CoV-2 Assay |
EUA 5/5/2020 | CE mark 4/2020 | PCR | |
| Snibe Diagnostics Maglumi 2019-nCoV (SARS-CoV-2) IgM/IgG kits |
CE mark 2/2020 | Serological | ||
| Snibe Diagnostics Maglumi SARS-CoV-2 S-RBD IgG kit |
CE mark 8/2020 | Serological | ||
| Solaris Diagnostics Solaris Multiplex SARS-CoV-2 Assay |
EUA 8/10/2020 | PCR | ||
| SolGent DiaPlexQ Novel Coronavirus (2019-nCoV) Detection kit |
EUA 5/21/2020 | CE mark 2/2020 | EUA, Korea Ministry of Food and Drug Safety; Philippines FDA | PCR |
| Sona Nanotech COVID-19 rapid antigen test |
EUA submission pending | Antigen | ||
| Sorrento Therapeutics COVI-Track Diagnostics Test |
EUA submission pending | Serological | ||
| Specialty Diagnostic (SDI) Laboratories SDI SARS-CoV-2 Assay |
EUA 4/10/2020 | PCR | ||
| Spectrum Solutions SDNA-1000 Saliva Collection Device |
EUA 10/8/2020 | Collection device | ||
| Stanford Health Care Clinical Virology Laboratory SARS-CoV-2 PCR Assay |
EUA 4/8/2020, reissued 11/24/2020 | PCR | ||
| Sugentech SGTi-flex COVID-19 IgG |
EUA 9/3/2020 | Serological | ||
| SureScreen Diagnostics SureScreen COVID19 IgM/IgG Rapid Test Cassette |
CE mark 2020 | Serological | ||
| Sysmex HISCL SARS-CoV-2 Ag Reagent |
Japan IVD approval for manufacturing and marketing | Antigen | ||
| Systaaq Diagnostic Products 2019-Novel Coronavirus (COVID-19) Real Time PCR Kit |
CE mark 3/2020 | PCR | ||
| T2 Biosystems T2SARS-CoV-2 Panel |
EUA 8/31/2020 | PCR | ||
| Tataa Biocenter TATAA GrandPerformance SARS-CoV-2 detection kit |
CE mark 3/2020 | PCR | ||
| TBG Biotechnology TBG SARS-CoV-2 IgG/IgM Rapid Test Kit |
EUA 8/31/2020 | CE mark 5/2020 | India CDSCO 10/2020 | Serological |
| TBG Biotechnology ExProbe SARS-CoV-2 Testing Kit |
EUA 6/10/2020 | CE mark 5/2020 | Taiwan FDA 7/2020, India CDSCO 10/2020 | PCR |
| Tempus Labs iC SARS-CoV2 Test |
EUA 10/1/2020 | PCR | ||
| Texas Department of State Health Services Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay |
EUA 8/21/2020 | PCR | ||
| Thermo Fisher Scientific EliA SARS-CoV-2-Sp1 IgG test |
CE mark 10/2020 | Serological | ||
| Thermo Fisher Scientific OmniPath COVID-19 Total Antibody ELISA Test |
EUA 10/2/2020 | CE mark 10/2020 | Serological | |
| Thermo Fisher Scientific TaqPath COVID-19 Combo Kit, RT-PCR CE-IVD Kit |
EUA 3/13/2020 (Combo kit), amended a href="https://www.fda.gov/media/136413/download">3/24/2020, 4/20/2020, 5/9/2020 | CE mark 3/2020 (CE-IVD kit) | Authorization in Australia, Singapore, Taiwan (Combo kit) | PCR |
| TIB Molbiol Syntheselabor Sarbecovirus E-gene |
CE mark 2/2020 | PCR | ||
| Tide Laboratories DTPM COVID-19 RT-PCR |
EUA 6/10/2020 | PCR | ||
| TNS (BioTNS) COVID-19 RT-PCR PNA Kit |
EUA 6/30/2020 | CE mark 5/2020 | PCR | |
| Trax Management Services Phoenix Dx 2019-CoV |
EUA 4/20/2020 | PCR | ||
| Trax Management Services Phoenix Dx SARS-CoV-2 Multiplex |
EUA 7/13/2020 | PCR | ||
| UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin SARS-CoV-2 RNA DETECTR Assay |
EUA 7/9/2020 | CRISPR | ||
| Ultimate Dx Laboratory UDX SARS-CoV-2 Molecular Assay |
EUA 4/20/2020 | PCR | ||
| UMass Memorial Medical Center UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel |
EUA 10/1/2020 | PCR | ||
| University of Alabama at Birmingham Fungal Reference Lab FRL SARS CoV-2 Test |
EUA 6/23/2020 | PCR | ||
| University of Arizona Genetics Core for Clinical Services COVID-19 ELISA pan-Ig Antibody Test |
EUA 8/31/2020 | Serological | ||
| University of California, Los Angeles UCLA SwabSeq COVID-19 Diagnostic Platform |
EUA 10/6/2020 | PCR | ||
| University of California San Diego Health UCSD RC SARS-CoV-2 Assay |
EUA 7/31/2020 | PCR | ||
| University of North Carolina Medical Center UNC Health SARS-CoV-2 real-time RT-PCR test |
EUA 4/10/2020 | PCR | ||
| University of Texas MD Anderson Cancer Center Molecular Diagnostics Laboratory MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay |
EUA 6/25/2020 | PCR | ||
| UTMG Pathology Laboratory UTHSC/UCH SARS-CoV-2-RT-PCR assay |
EUA 5/3/2020 | PCR | ||
| Vela Diagnostics ViroKey SARS-CoV-2 RT-PCR Test v2.0 |
EUA 9/22/2020 | CE mark 7/2020 | PCR | |
| Vela Diagnostics ViroKey SARS-CoV-2 RT-PCR Test |
EUA 8/5/2020 | CE mark 4/2020 | Singapore Health Sciences Authority provisional authorization | PCR |
| Veredus Laboratories ZeroPrep Saliva Collection Kit and extraction-free VereRT ZeroPrep COVID-19 PCR Kit |
Singapore Health Sciences Authority provisional authorization 12/2020 | PCR | ||
| Veredus Laboratories VereCoV OneMix Detection Kit |
pending | Singapore Health Sciences Authority provisional authorization 10/2020 | PCR, microarray | |
| Veredus Laboratories VereRT COVID-19 PCR Kit (previously VereRTCoV SARS-CoV-2 Real-Time RT-PCR) |
CE mark 6/2020 (pending for an updated product) | Singapore Health Sciences Authority provisional authorization 6/2020 | PCR | |
| Veredus Laboratories VereRT ZeroPrep COVID-19 PCR Kit (previously VereRTCoV 3.0 ZeroStep Real-Time RT-PCR) |
CE mark 8/2020 (old product name) | Singapore Health Sciences Authority provisional authorization 8/2020 | PCR | |
| Veredus Laboratories VereCoV Detection Kit |
CE mark 3/2020 | Singapore Health Sciences Authority provisional authorization 2/2020 | PCR | |
| Verily Life Sciences Verily COVID-19 RT-PCR Test |
EUA 9/8/2020 | PCR | ||
| Vibrant America Clinical Labs Vibrant COVID-19 Ab Assay |
EUA 6/4/2020 | Serological | ||
| Viracor Eurofins Coronavirus SARS-CoV-2 RT-PCR assay |
EUA 4/6/2020 | PCR | ||
| Visby Medical Visby Medical COVID-19 |
EUA 9/16/2020 | PCR | ||
| Vision Medicals SARS-CoV-2 Clinical Sequencing assay |
CE mark 3/2020 | PCR | ||
| Wadsworth Center, New York Department of Health New York SARS-CoV Microsphere Immunoassay for Antibody Detection |
EUA 4/30/2020 | Serological | ||
| Warrior Diagnostics Warrior Diagnostics SARS-CoV-2 Assay |
EUA 6/9/2020 | PCR | ||
| Wren Laboratories Wren Laboratories COVID-19 PCR Test |
EUA 8/3/2020, reissued 10/20/2020 | PCR | ||
| Xiamen Biotime Biotechnology Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test |
EUA 7/24/2020 | Serological | ||
| Xiamen Wiz Biotech Diagnostic Kit (Colloidal Gold) IgG/IgM Antibody to SARS-CoV-2 |
CE mark 3/2020 | Serological | ||
| Xiamen Zeesan Biotech SARS-CoV-2 Test Kit (Real-time PCR) |
EUA 7/31/2020 | PCR | ||
| Yale New Haven Hospital Clinical Virology Laboratory SARS-CoV-2 PCR test |
EUA 3/31/2020 | PCR | ||
| Yale School of Public Health SalivaDirect |
EUA 8/15/2020, reissued 8/28/2020 | PCR | ||
| YD Diagnostics MolecuTech Real-Time COVID-19 |
EUA submission pending | CE mark 3/2020 | India 4/2020 | PCR |
| Yourgene Health Clarigene SARS CoV-2 |
CE mark 8/2020 | PCR | ||
| Zeus Scientific Zeus ELISA SARS-CoV-2 IgG Test System |
EUA 10/6/2020 | Serological | ||
| Zhejiang Orient Gene Biotech Coronavirus Ag Rapid Test Cassette |
CE mark 7/2020 | Antigen | ||
| Zhejiang Orient Gene Biotech COVID-19 IgG/IgM Rapid Test Cassette |
CE mark 4/2020 | Serological | ||
| Zhejiang Orient Gene Biotech Coronavirus Detection Kit |
CE mark 4/2020 | PCR | ||
| Zhejiang Orient Gene Biotech 2019-nCoV and SARS-CoV Detection Kit |
CE mark 4/2020 | PCR | ||
| Zhejiang Orient Gene Biotech SARS-CoV-2 Detection Kit |
CE mark 4/2020 | PCR | ||
| Zhuhai Lituo Biotechnology COVID-19 Antigen Detection Kit (Colloidal Gold) |
CE mark 7/2020 | Antigen | ||
| ZhuHai Sinochips Bioscience COVID-19 Nucleic Acid RT-PCR Test Kit |
EUA 8/17/2020 | PCR | ||
| Zymo Research Quick SARS-CoV-2 Multiplex Kit |
CE mark 11/2020 | PCR | ||
| Zymo Research Quick SARS-CoV-2rRT-PCR Kit |
EUA 5/7/2020 | CE mark 7/2020 | PCR |