Coronavirus Test Tracker: Commercially Available COVID-19 Diagnostic Tests
As labs and diagnostic developers race to meet demand for assays to detect the SARS-CoV-2 coronavirus, 360Dx is updating this tracker on a regular basis in order to provide readers with up-to-date and accurate information on the regulatory status of these tests in the US, European, and Asian markets.
The tracker includes only those tests that are available for diagnostic and clinical use. Links to primary regulatory decisions are provided where available. This table is updated to the best of our ability and may not include every commercially available test. We rely on information provided by manufacturers and regulatory authorities. If you're a test manufacturer or provider and believe your test should be on this tracker, please email us at [email protected].
Last updated: October 15, 2024
EUA: Emergency Use Authorization
EUA submission pending: Test manufacturers have indicated that they have submitted an EUA application. FDA requires labs and commercial manufacturers to submit an EUA request within 10 days (serological test) or 15 days (molecular test) of completing test validation.
Under CDC's EUA: these manufacturers are covered under the EUA granted to the US Centers for Disease Control and Prevention
*See US FDA Revised Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency
| Company/Organization Name |
Test Name | US Regulatory Status* | EU Regulatory Status | Asia/Canada 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, reissued 12/17/2020 |
PCR | ||
| 3D Medicines |
SARS-CoV-2 and Influenza A & B RT-qPCR Detection Kit |
CE mark 3/2020 | PCR | ||
| 3EO Health | 3EO Health COVID-19 Test | EUA 9/19/2023 | Isothermal amplification | ||
| Abacus Diagnostica |
GenomEra SARS-CoV-2 Assay |
CE mark 7/2020 | PCR | ||
| Abacus Diagnostica | GenomEra SARS-CoV-2 2.0 Assay | CE mark 2/2022 | PCR | ||
| Abbott | Panbio Rapid Antigen Self-Test | CE mark 6/2021 | Antigen | ||
| Abbott |
Alinity m Resp-4-Plex |
EUA 3/4/2021 | CE mark | PCR | |
| Abbott |
Alinity m SARS-CoV-2 assay |
EUA 12/23/2020 | PCR | ||
| Abbott |
SARS-CoV-2 IgG II Quant antibody test |
CE mark 12/2020 | Serological | ||
| Abbott |
Advise SARS-CoV-2 IgG II |
EUA 3/1/2021 | Serological | ||
| Abbott |
AdviseDx SARS-CoV-2 IgM |
EUA 10/9/2020 | Serological | ||
| Abbott |
BinaxNow COVID-19 Antigen Self Test |
Antigen | |||
| Abbott |
BinaxNow COVID-19 Ag Card2 Home Test |
EUA 3/31/2021, revoked 2/24/2022 |
Antigen | ||
| Abbott |
BinaxNow COVID-19 Ag 2 Card |
Antigen | |||
| Abbott |
BinaxNow COVID-19 Ag Card |
EUA 8/26/2020, reissued 12/16/2020. Revoked 1/31/2023. |
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 | ID Now COVID-19 2.0 | EUA 5/6/2022 | Isothermal amplification | ||
| Abbott | Abbott RealTime SARS-CoV-2 EUA test | EUA 3/18/2020 | PCR | ||
| Abionic | IVD Capsule COVID-19 Test | CE mark 11/2021 | Antigen | ||
| Access Bio | CareStart COVID-19 Antigen Home Test | EUA 8/2/2021 | Antigen | ||
|
Access Bio |
CareStart COVID-19 Antigen test |
EUA 10/8/2020 | CE mark 9/2020 | Antigen | |
| Access Bio | CareStart EZ COVID-19 IgM/IgG | EUA 6/24/2021 | Serological | ||
|
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 | ||
| Achiko | AptameX | CE mark 5/2022 | Aptamer | ||
| Acon Laboratories | Flowflex COVID-19 Antigen Home Test | EUA 10/4/2021 | Antigen | ||
|
Acon Laboratories |
Acon SARS-CoV-2 IgG/IgM Rapid Test |
EUA 12/15/2020 | Serological | ||
| Actim | Actim SARS-CoV-2 rapid test | CE mark 5/2021 | Antigen | ||
|
Acupath Laboratories |
Acupath COVID-19 Real-Time (RT-PCR) Assay |
EUA 6/29/2020 | PCR | ||
|
ADS Biotec |
COVID-19 Rapid Antigen Test |
CE mark 1/2021 | Antigen | ||
|
Advaite |
RapCov Rapid COVID-19 Test |
EUA 1/11/2021 | Serological | ||
| Advanced Biological Laboratories | DeepChek Whole Genome SARS-CoV-2 Genotyping Assay | CE mark 5/2021 | Sequencing | ||
| Advanced Biological Laboratories | UltraGene SARS-CoV-2 Triplex Assay | CE mark 4/2021 | PCR | ||
|
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 |
CE mark 12/2020 |
Taiwan EUA 8/2020 Indian Council of Medical Research validation 9/2020 Singapore Health Sciences Authority provisional authorization 12/2020 |
Antigen | |
|
Agena Bioscience |
MassArray SARS-CoV-2 Panel |
EUA 10/26/2020 | CE mark 9/2020 | Mass spectrometry | |
|
Agilent Technologies |
Agilent SARS-CoV-2 qRT-PCR Dx kit |
CE mark 3/2021 | PCR | ||
|
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, revoked 12/8/2021 | PCR | ||
| Alimetrix |
Alimetrix SARS-CoV-2 RT-PCR Assay |
EUA 9/30/2020 | PCR, microarray | ||
| 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-CoV-2 RT-PCR Kits (1.0 and U.S versions) |
EUA 4/22/2020 | CE mark 4/2020 | PCR | |
| Amazon/SDS Lab Holdco | Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test | EUA 8/11/2021; revoked 7/19/2022 | PCR | ||
| Amazon/SDS Lab Holdco | Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test | EUA 8/11/2021; revoked 7/19/2022 | PCR | ||
| Amazon/SDS Lab Holdco | Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 | EUA 5/28/2021; revoked 7/19/2022 | PCR | ||
| Amazon/SDS Lab Holdco |
Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 |
EUA 3/25/2021 | PCR | ||
| Ambry Genetics |
Ambry COVID-19 RT-PCR Test |
EUA 1/22/2021 |
|
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-2Complete RTU |
CE mark 6/2020 | PCR | ||
| ANP Technologies | NIDS COVID-19 Antigen Rapid Test Kit | EUA 9/24/2021 | Antigen | ||
| AnteoTech | EuGeni COVID-19 Antigen Rapid Test (ART) | CE mark 4/2021, updated 5/2022 | Antigen | ||
| Applied BioCode | BioCode CoV-2 Flu Plus Assay | EUA 12/15/2021 | PCR | ||
|
Applied BioCode |
BioCode SARS-CoV-2 Assay |
EUA 6/15/2020, reissued 12/7/2020 | PCR | ||
|
Applied DNA Sciences |
Linea COVID-19 RT-PCR test |
EUA 5/13/2020, revoked 4/20/2022 | 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 DTC |
EUA 2/13/2021 | PCR | ||
| Assurance Scientific Laboratories |
Assurance SARS-CoV-2 Panel |
EUA 5/15/2020 | PCR | ||
|
Assure Tech |
FaStep COVID-19 Rapid Antigen Test Device |
Health Canada | Antigen | ||
|
Assure Tech |
EcoTest COVID-19 Antigen Rapid Test |
Health Canada | Antigen | ||
|
Assure Tech |
EcoTest COVID-19 IgM/IgG Antibody Rapid Test |
Health Canada | Serological | ||
|
Assure Tech |
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 | ||
| Audere | HealthPulse@home kit | EUA 11/30/2021 | Collection kit | ||
| Audere | HealthPulse@home Fusion | EUA 4/26/2022 | Collection kit | ||
| AusDiagnostics |
AusDiagnostics SARS-CoV-2, influenza, RSV panel |
CE mark 3/2020 | PCR | ||
| Autobio Diagnostics | Anti-SARS-CoV-2 Rapid Test | CE mark | Serological | ||
| Avacta Life Sciences | AffiDX SARS-CoV-2 Antigen Lateral Flow Test |
CE mark 5/2021 CE mark 12/2021 (self-test) |
Antigen | ||
| 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, revoked 2/14/2023 | Serological | ||
| Baebies | Finder SARS-CoV-2 | CE mark 3/2022 | PCR | ||
|
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-CoV-2 RT PCR Assay |
EUA 8/31/2020 | PCR | ||
|
Beckman Coulter |
Access SARS-CoV-2 IgG II |
EUA 3/22/2021 | Serological | ||
|
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 At-Home COVID-19 Test | EUA 8/24/2021, revoked 6/15/2023 | Antigen | ||
|
Becton Dickinson |
BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B |
EUA 3/24/2021 | Antigen | ||
|
Becton Dickinson |
BD SARS-CoV-2/Flu Assay |
EUA 2/10/2021; revoked 7/29/2022 | CE mark 5/2022 | PCR | |
|
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, revoked 12/8/2021 | 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 | ||
| Beroni Group | COVID-19 Antigen Rapid Test Kit - Colloidal Gold Method | CE mark 6/2022 | Antigen | ||
| BforCure | Bfast [SARS-CoV-2] RT-PCR kit | CE mark 10/2021 | PCR | ||
| 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 SARS-2019-nCoV | EUA 3/26/2020 | CE mark 3/2/2020 | China NMPA 1/2020 | PCR |
|
BillionToOne |
qSanger-COVID-19 Assay |
EUA 9/4/2020, revoked 3/10/2022 | Sequencing | ||
|
Binx Health |
Binx Health At-Home Nasal Swab COVID-19 Sample Collection Kit |
EUA 10/20/2020 | Collection kit | ||
| Biobase Biodustry | 2019-nCOV IgM/IgG Antibody Test Kit (Colloidal Gold) | CE mark 3/2020 | Serological | ||
| Biobase Biodustry | SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | CE mark | Antigen | ||
|
Biocan Diagnostics |
Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test |
EUA 8/25/2020 | Serological | ||
| Biocartis | Idylla SARS-CoV-2/Flu/RSV Panel | CE mark 8/2021 | PCR | ||
|
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 20019-nCoV Real Time PCR Kit |
EUA 5/21/2020 | PCR | ||
|
Biodesix |
SARS-CoV-2 Droplet Digital PCR (ddPCR) test |
EUA submission pending | PCR | ||
| BioEcho Life Sciences | EchoLution Viral RNA/DNA Swab Kit | CE mark 5/2021 | Collection Kit | ||
|
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 6/29/2021 | PCR | ||
|
Biohit Healthcare (Hefei) |
Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit |
EUA 6/18/2020 | CE mark 3/2020 | Serological | |
| BioLytical Laboratories | iStatis COVID-19 Antigen Test | Health Canada authorization 3/2022 | Antigen | ||
| BioLytical Laboratories | iStatis COVID-19 Antigen Home Test | CE mark 3/2022 | Health Canada authorization 4/2022 | Antigen | |
|
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 Rapid Antigen Test |
CE mark 1/2021 | Antigen | ||
| Biomerica |
COVID-19 IgG/IgM Rapid Test |
CE mark 5/2020 | Serological | ||
| BioMérieux | Vidas SARS-COV-2 IgG II | CE mark 5/2021 | Serological | ||
| BioMérieux |
Vidas anti-SARS-CoV-2 IgM test |
EUA 8/6/2020, revoked 1/31/2024 | CE mark 5/2020 | Serological | |
| BioMérieux | Vidas anti-SARS-CoV-2 IgG test | EUA 8/6/2020, revoked 1/31/2024 | 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, revoked 12/17/2021 | CE mark 4/10/2020 | PCR | |
|
BioMérieux/BioFire Defense |
BioFire COVID-19 test |
EUA 3/23/2020, reissued 12/4/2020 | PCR | ||
| BioMérieux/BioFire Diagnostics |
BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) |
EUA 10/2/2020 | PCR | ||
| BioMérieux/BioFire Diagnostics |
BioFire Respiratory Panel 2.1 (RP2.1) (EUA) BioFire Respiratory Panel 2.1 plus (CE mark) |
EUA 5/1/2020, replaced by de novo premarket authorization 3/17/2021 revoked 3/17/2021 |
CE mark 7/2020 | PCR | |
| Bioneer |
AccuPower RV1 Multiplex 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 3/2020 | PCR | ||
| Bioneer |
AccuPower RV1 Real-Time RT-PCR Kit |
CE mark 11/2020 | PCR | ||
| Biopanda Reagents |
COVID-19 Rapid Antibody Test |
CE mark 3/2020 | Serological | ||
| Biopix-T | COV19 qcLAMP kit | CE mark 10/2021 | Isothermal amplification | ||
| Bio-Rad Laboratories | BioPlex 2200 SARS-CoV-2 IgG | EUA 7/1/2021, revoked 1/11/2022 | Serological | ||
| Bio-Rad Laboratories |
Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit |
EUA 2/11/2021, revoked 4/14/2022 | CE mark 7/2021 | PCR | |
| Bio-Rad Laboratories |
Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit |
EUA 1/15/2021, revoked 1/16/2024 | CE mark 5/2021 | PCR | |
| Bio-Rad Laboratories |
Bio-Rad SARS-CoV-2 ddPCR Test |
EUA 5/1/2020, revoked 3/27/2024 | 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 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, revoked 12/18/2021 | PCR | ||
|
Broad Institute Clinical Research Sequencing Platform (CRSP) |
CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay Version 3 |
EUA 3/5/2021, revoked 7/3/2023 | 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 and 12/18/2020 Revoked 5/5/2022 |
PCR | ||
| Bruker | FluoroType SARS-CoV-2 varID Q | CE mark 6/2021 | 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 | ||
| C4Diagnostics | C4Covid-19 Human | CE mark 4/2021 | Isothermal amplification | ||
|
Capstone Healthcare |
Genus SARS-CoV-2 Assay |
EUA 8/3/2020 | PCR | ||
| Canary Global | DigiGene COVID-19 Rapid Molecular Test Kit | CE mark 1/2022 | Isothermal amplification | ||
|
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, revoked 12/10/2021 | Serological | ||
| Celltrion | Celltrion DiaTrust COVID-19 Ag Home Test | EUA 10/21/21, revoked 7/30/2024 | Antigen | ||
| Celltrion |
Celltrion DiaTrust COVID-19 Ag Rapid Test |
EUA 4/16/2021, revoked 7/30/2024 | Antigen | ||
| Celltrion |
Sampinute COVID-19 Antigen MIA |
EUA 10/23/2020, revoked 7/30/2024 | 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, revoked 3/17/2022 | PCR | ||
| Centogene |
CentoFast SARS-CoV-2 RT-PCR test |
EUA 7/1/2020, revoked 3/17/2022 | PCR | ||
| Cepheid | Xpert Xpress SARS-CoV-2/Flu/RSV plus | EUA 9/10/2021 | CE mark 10/2021 | PCR | |
| Cepheid | Xpert Xpress CoV-2 plus | EUA 5/10/2022 | CE mark 5/2022 | PCR | |
| Cepheid |
Xpert Xpress SARS-CoV-2 DoD |
EUA 12/23/2020 | PCR | ||
| Cepheid |
Xpert Omni SARS-CoV-2 |
EUA 11/27/2020, revoked 12/20/2021 | PCR | ||
| Cepheid |
Xpert Xpress SARS-CoV-2/Flu/RSV test |
EUA 9/24/2020, revoked 4/17/2023 | CE mark 11/2020 | PCR | |
| Cepheid |
Xpert Xpress SARS-CoV-2 test |
EUA 3/20/2020 | PCR | ||
| CerTest BioTec | Viasure SARS-CoV-2 Variant Real Time PCR Detection Kit | CE mark 8/2021 on BD Max system | PCR | ||
| CerTest BioTec |
Viasure SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit |
CE mark 10/2020 on BD Max system | PCR | ||
| 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 | Serological | |||
| Chil | Chil COVID-19 Antigen Rapid Test | CE mark 10/2020 | Antigen | ||
|
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, revoked 1/3/2023 | 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. Tomsich Pathology and Laboratory Medicine Institute | SelfCheck Cobas SARS-CoV-2 Assay | EUA 9/29/2021 | PCR | ||
| Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute | SelfCheck COVID-19 TaqPath Multiplex PCR | EUA 8/9/2021 | PCR | ||
| Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute |
Cleveland Clinic SARS-CoV- Assay |
EUA 8/3/2020 | PCR | ||
| Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute | SelfCheck Cobas SARS-CoV-2 + Flu Assay | EUA 4/11/2022 | PCR | ||
| Clinical Enterprise (Eurofins) |
Clinical Enterprise SARS-CoV-2 RT-PCR Assay DTC |
PCR | |||
| Clinical Enterprise (Eurofins) |
Clinical Enterprise SARS-CoV-2 RT-PCR Assay |
PCR | |||
| Clinical Enterprise (Eurofins) |
EmpowerDX At-Home COVID-19 PCR Test Kit DTC |
EUA 10/15/2020, reissued 2/26/2021 |
Collection kit | ||
| Clinical Reference Laboratory |
CRL Rapid Response |
EUA 7/30/2020 | Molecular | ||
| Clinomics |
Clinomics TrioDx RT-PCR COVID-19 Test |
EUA 2/4/2021 | PCR | ||
| Co-Diagnostics | Logix Smart SARS-CoV-2 DS (Direct Saliva) | CE mark 6/2021 | PCR | ||
| 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 Disease 2019 (COVID-19) Kit |
EUA 4/3/2020 | CE mark 2/2020 | PCR | |
|
Color Health |
Color COVID-19 Self-Swab Collection Kit with Saline |
EUA 4/14/2021 | Collection kit | ||
|
Color Health |
Color COVID-19 Self-Swab Collection Kit DTC |
EUA 3/19/2021 | Collection kit | ||
|
Color Health |
Color COVID-19 Self-Swab Collection Kit |
EUA 8/31/2020 | Collection kit | ||
|
Color Health |
Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC |
EUA 3/19/2021 | Isothermal amplification | ||
|
Color Health |
Color SARS-CoV-2 LAMP Diagnostic Assay |
EUA 5/18/2020, reissued 11/2/2021 | 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 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 |
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 for Home and Over The Counter (OTC) Use |
EUA 3/5/2021, revoked 10/9/2024 | Health Canada authorization 3/2022 | Isothermal amplification | |
| Cue Health |
Cue COVID-19 Test |
EUA 6/10/2020, revoked 10/9/2024 | CE mark 2/2021 | Isothermal amplification | |
|
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, revoked 8/23/2023 | PCR | ||
| DC Department of Health | Test Yourself DC At-Home COVID-19 Collection Kit | EUA 4/6/2022 | Home collection kit | ||
| Deep Sensing Algorithms | DSA BreathPass | CE mark 2/2022 | Biosensor | ||
| Detect | Detect Covid-19 Test | EUA 10/28/2021, revoked 4/14/2023 | Isothermal amplification | ||
|
Detectachem |
MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit |
EUA 9/1/2020 | Isothermal amplification | ||
| Diabetomics | CovAb SARS-CoV2 Ab Test | EUA 6/4/2021 | Serological | ||
| DiaCarta | QuantiVirus SARS-CoV-2 Variant Detection Test | CE mark 8/2021 | 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 TrimericS IgG | EUA 5/19/2021 | Serological | ||
| DiaSorin |
Liaison SARS-CoV-2 Ag |
EUA 3/26/2021 | CE mark 10/2020 | Antigen | |
| DiaSorin |
Diasorin Liaison SARS-CoV-2 IgM Assay |
EUA 9/29/2020, revoked 3/15/2022 | 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 | 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 | ||
| Diazyme Laboratories |
Diazyme DZ-Lite SARS-CoV-2 IgM |
EUA 8/17/2020 | Serological | ||
|
DNA Genotek/OraSure Technologies |
ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100saliva 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, reissued 10/28/2020 | 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 | ||
| Drexel University College of Medicine | SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay | EUA 4/19/2021, revoked 10/5/2023 | PCR | ||
| DxLab | DxLab COVID-19 Test | EUA 6/1/2022 | Isothermal amplification | ||
|
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 | ||
| Ellume | Ellume.lab COVID Antigen Test | EUA 7/8/2021 | Antigen | ||
| Emory Medical Laboratories |
SARS-CoV-2 RBD IgG test |
EUA 6/15/2020 | Serological | ||
| Empire City Laboratories | ECL COVID Test System-1 | EUA 8/25/2021 | PCR | ||
| Empire City Laboratories | ECL COVID Test System | EUA 8/25/2021 | PCR | ||
| Empirical Bioscience |
QuantiTase, QuantiTase Plus One Step RT-qPCR Kits |
EUA submission pending | PCR | ||
| Empowered Diagnostics | CovClear | CE mark | Health Canada | Antigen | |
| Ender Diagnostics |
Ender Lab |
CE mark 6/2020 | PCR | ||
| Ender Diagnostics |
Ender Mass |
CE mark 8/2020 | Isothermal amplification | ||
| Enzo Biochem |
Ampicollect Sample Collection Kit |
EUA 4/2021 | Collection device | ||
| 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 |
CE mark 4/2020 | Serological | ||
| Ethos Laboratories |
Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay |
EUA 8/3/2020 | Mass spectrometry | ||
| Eurobio Scientific | EBX 042 FluCoSyn test | CE mark 9/2020 | PCR | ||
| Eurobio Scientific | EBX 048 Eurobioplex SARS-CoV-2 Fast-SVT test | CE mark 4/2022 | PCR | ||
| Eurofins Ingenasa |
Ingezim COVID 19 DR |
CE mark 6/2020 | Serological | ||
| Euroimmun/PerkinElmer | Anti-SARS-CoV-2 S1 Curve ELISA (IgG) | EUA 10/4/2021 | 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 |
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 ELISA (IgA) |
CE mark 3/2020 | Serological | ||
| Everlywell | Everlywell COVID-19 & Flu Test Home Collection Kit | EUA 7/1/2021 | Home collection kit | ||
|
Everlywell |
Everlywell COVID-19 Test Home Collection Kit DTC |
EUA 2/13/2021 | Home collection kit | ||
|
Everlywell |
Everlywell COVID-19 Test Home Collection Kit |
EUA 5/15/2020 | Home collection kit | ||
| Exact Sciences | COVID-Flu Multiplex Assay | EUA 7/1/2021, revoked 8/18/2023 | PCR | ||
|
Exact Sciences |
Exact Sciences SARS-CoV-2 (N gene detection) Test |
EUA 5/22/2020, revoked 8/18/2023 | 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, reissued 2/26/2021. Revoked 2/1/2023 |
CE mark 1/2021 | PCR | |
| Fluidigm | Advanta Dx COVID-19 EASE Assay | EUA 2/7/2022/ Revoked 2/1/2023 | PCR | ||
|
Fluxergy |
COVID-19 Sample-to-Answer RT-PCR test |
CE mark 3/2021 | PCR | ||
| Fosun Diagnostics | Novel Coronavirus Antigen Detection Kit | China National Medical Products Administration 4/2022 | Antigen | ||
|
Fosun Pharma USA |
Fosun COVID-19 RT-PCR Detection Kit |
EUA 4/17/2020 | PCR | ||
| Fujifilm Europe | SARS-CoV-2 Antigen | CE mark 3/2021 | Antigen | ||
| Fulgent Genetics/Fulgent Therapeutics | Fulgent COVID-19 by RT-PCR Test | EUA 5/15/2020 | PCR | ||
| Gemina Laboratories | Gemina Legio X COVID-19 Rapid Antigen Test | CE mark 5/2022 | Antigen | ||
| Genalyte |
Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2 |
EUA 10/8/2020 | Serological | ||
| Gencurix |
GenePro SARS-CoV-2 Test |
EUA 6/23/2020 | PCR | ||
| Genomtec | SARS-CoV-2 EvaGreen Direct-RT-LAMP Kit | CE mark 5/2021 | Isothermal amplification | ||
| Genomtec | Genomtec ID Respiratory Panel 5-Plex | CE mark 6/2022 | Isothermal amplification | ||
| Gene By Gene |
Gene By Gene SARS-CoV-2 Detection Test |
EUA 7/7/2020 | PCR | ||
| Genecast | Smartrol 2019-nCoV Detection Kit v1 | CE mark 6/2020 | Korea Ministry of Food and Drug Safety 5/2020 | 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 | ||
| GeneMe |
Fast Reliable Accurate Nucleic Acid-Based Kit for COVID-19 Detection (FRANKD) |
CE mark 5/2020 | Isothermal amplification | ||
| 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 |
EasyScreen SARS-CoV-2 detection kit |
CE mark 3/2020 | PCR | ||
| Genetrack Biolabs |
Genetrack SARS-CoV-2 Molecular Assay |
EUA 9/25/2020 | PCR | ||
| Genetron |
Genetron SARS-CoV-2 RNA Test |
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 | CE mark 9/2020 | 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 Healt Laboratory |
GWU COVID-19 RT-PCR Test |
EUA 8/7/2020 | PCR | ||
|
GetMyDNA |
GetMyDNA COVID-19 Test Home Collection Kit |
EUA 3/9/2021 | Home collection kit | ||
|
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 NovaType II SARS-CoV-2 | CE mark 4/2021 | 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 for use with DTC kits |
EUA 2/13/2021 | PCR | ||
|
Gravity Diagnostics |
Gravity Diagnostics SARS-CoV-2 RT-PCR Assay |
EUA 11/23/2020 | PCR | ||
|
Gravity Diagnostics |
Gravity Diagnostics COVID-19 Assay |
revoked 7/21/2021 |
PCR | ||
|
Grifols Diagnostic Solutions |
Procleix SARS-CoV-2 Assay |
EUA 2/10/2021, revoked 8/15/2024 | CE mark 5/2020 | Isothermal amplification | |
|
Guardant Health |
Guardant-19 |
revoked 8/6/2021 |
Sequencing | ||
| HA Tech |
SARS-CoV-2 RT-PCR Multiplex Diagnostic Kit |
CE mark 3/2021 | PCR | ||
|
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 | ||
| Harvard University Clinical Laboratory (HUCL) | Quaeris SARS-CoV-2 Assay | EUA 5/21/2021 | PCR | ||
| Hayat Genetics |
Hayat Rapid Colorimetric & Fluorimetric One Step 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 | ||
| Helix | Helix SARS-CoV-2 Test | EUA 3/17/2022 | PCR | ||
| Hologic | Aptima SARS-CoV-2 assay with saliva sample | CE mark 7/2021 | 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 | ||
| iHealth Labs | iHealth COVID-19 Antigen Rapid Test | EUA 11/5/2021 | Antigen | ||
| iHealth Labs | iHealth COVID-19 Antigen Rapid Test Pro | EUA 1/14/2022 | Antigen | ||
| 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 | ||
| Immunodiagnostic Systems |
IDS SARS-CoV-2 IgG |
EUA 2/10/2021 | Serological | ||
| InBios International | SCoV-2 Ag Detect Rapid Self-Test | EUA 11/22/2021 | Antigen | ||
| InBios International | SCoV-2 Detect Neutralizing Ab ELISA | EUA 10/22/2021 | Serological | ||
| InBios International | SCoV-2 Detect IgG Rapid Test | EUA 8/24/2021 | Serological | ||
| InBios International | SCoV-2 Ag Detect Rapid Test | EUA 5/6/2021 | Antigen | ||
| 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 | ||
| Infusion Tech | Primera COVID-19 RT-PCR Detection Kit | CE mark 5/2022 | PCR | ||
|
Innocreate Bioscience |
Innocreate SARS-CoV-2 QD kit | Taiwan Food and Drug Administration approval | PCR | ||
|
Inno Diagnostics |
PMSF-Inno SARS-CoV-2 RT-PCR Test |
EUA 1/19/2021 | PCR | ||
|
Innovita (Tangshan) Biological Technology |
Innovita 2019-nCoV Ab Test (Colloidal Gold) |
EUA 11/23/2020 | Serological | ||
| Innova Medical Group | Innova SARS-CoV-2 Antigen Rapid Qualitative Test | CE mark 3/2022 | UK MHRA approval | Antigen | |
| Innova Medical Group | Innova SARS-CoV-2 Antigen Rapid Qualitative Self-Test | CE mark 6/2022 | Antigen | ||
| Inova Diagnostics | Quanta Flash SARS-CoV-2 IgG | EUA 4/19/2021 | Serological | ||
| InspectIR Systems | InspectIR COVID-19 Breathalyzer | EUA 4/14/2022 | Mass spectrometry | ||
| 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 | ||
| iXensor |
PixoTest POCT COVID-19 Antigen Test |
CE mark 6/2021 | Antigen | ||
|
Jiangsu Bioperfectus Technologies |
COVID-19 Coronavirus Real Time PCR Kit |
EUA 6/18/2020 | PCR | ||
| Jiangsu Macro & Micro-Test Med-Tech | SARS-CoV-2/influenza A/influenza B Nucleic Acid Combined Detection Kit | CE mark 8/2021 | 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 FDA | PCR |
| Kaiser Permanente Mid-Atlantic States | KPMAS COVID-19 Test | EUA 6/13/2020 | PCR | ||
| Kantaro Biosciences |
COVID-SeroKlir, COVID-SeroIndex quantitative SARS-CoV-2 IgG antibody test kits |
EUA 11/25/2020 (COVID-SeroKlir) | CE mark 10/2020 | Serological | |
| Kaya 17 |
Kaya 17 Rapid Antigen Test |
CE mark 2/2021 | Antigen | ||
| 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 |
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) |
Curative-Korva SARS-Cov-2 Assay |
revoked 7/15/2021 |
PCR | ||
|
Kroger Health |
Kroger Health COVID-19 Test Home Collection Kit |
EUA 6/30/2020 | Home collection kit | ||
| Kwokman Diagnostics | Kwokman Diagnostics COVID-19 Home Collection Kit | EUA 8/13/2021 | 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, EUA revoked 9/21/2022 | PCR | ||
| Laboratory Corporation of America | Labcorp SARS-CoV-2 & Influenza A/B Assay | EUA 9/30/2021 | Collection kit | ||
| Laboratory Corporation of America | Labcorp Seasonal Respiratory Virus RT-PCR DTC Test | EUA 5/16/2022 | PCR | ||
| Laboratory Corporation of America | Labcorp Seasonal Respiratory Virus RT-PCR Test | EUA 5/17/2022 | PCR | ||
| Laboratory Corporation of America | COVID-19 RT-PCR Test |
EUA 3/16/2020, reissued 4/20/2020, 7/24/2020, 9/18/2020, 12/9/2020 |
PCR | ||
| Laboratory Corporation of America | Labcorp VirSeq SARS-CoV-2 NGS Test | EUA 6/10/2022 | Sequencing | ||
| 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 4/15/2021, revoked 6/1/2023 | PCR | ||
| LGC, Biosearch Technologies |
2019-nCoV CDC-qualified Probe and Primer Kits for SARS-CoV-2 |
under CDC's EUA | PCR | ||
| LGC, Biosearch Technologies | Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test | EUA 4/26/2022, revoked 6/1/2023 | PCR | ||
| LG Chem | AdvanSure SARS-CoV-2 IgG(S1) ELISA | EUA 5/19/2022 | Serological | ||
| LG Chem | AdvanSure SARS-CoV-2 IgG(RBD) ELISA | EUA 5/31/2022 | Serological | ||
| LifeHope Labs |
LifeHope2019-nCoV Real-Time RT-PCR Diagnostic Panel |
EUA 6/29/2020, revoked 2/7/2022 | PCR | ||
| Life Sciences Testing Center | Life Sciences Testing Center COVID-19 Test | EUA 9/22/2021 | PCR | ||
| LMSI (Lighthouse Lab Services) | CovidNow SARS-CoV-2 Assay | EUA 10/14/2021 | PCR | ||
| Lucira Health |
Lucira COVID-19 Test |
EUA 4/9/2021 | CE mark 5/2022 | Health Canada 4/2021 | LAMP |
| Lucira Health |
Lucira COVID-19 All-In-One Test Kit |
EUA 11/17/2020 | LAMP | ||
| Lucira Health | Lucira COVID-19 & Flu Test | CE mark 5/2022 | LAMP | ||
| Luminex |
NxTAG RPP + SARS-CoV-2 Assay |
EUA 3/3/2021 | CE mark 2/2021 | PCR | |
| Luminex |
xMAP SARS-CoV-2 Multi-Antigen IgG Assay |
EUA 7/16/2020, revoked 2/22/2024 | Serological | ||
| Luminex |
ARIES SARS-CoV-2 Assay |
EUA 4/3/2020, amended 5/11/2020 | PCR | ||
| Luminex | Aries Flu A/B & RSV+SARS-CoV-2 Assay | CE mark 5/2022 | PCR | ||
| Luminex |
NxTAGCoV Extended Panel Assay |
EUA 3/27/2020 | PCR | ||
|
Luminostics |
Clip COVID Rapid Antigen Test |
EUA 12/7/2020, revoked 5/5/2023 | Antigen | ||
| LumiraDx | SARS-CoV-2 Ag Ultra Test | CE mark 5/2022 | Antigen | ||
| LumiraDx | LumiraDx SARS-CoV-2 & Flu A/B Rapid Antigen Test | CE mark 12/2021 | Antigen | ||
| LumiraDx | LumiraDx SARS-CoV-2 Ab Test | EUA 8/2/2021 | Serological | ||
| LumiraDx | LumiraDx SARS-CoV-2 Ag Pool Test | EUA 3/2021 | Antigen | ||
|
LumiraDx |
LumiraDx SARS-CoV-2 RNA STAR Complete |
EUA 10/14/2020, revoked 8/7/2024 | CE mark 6/2021 | PCR | |
|
LumiraDx |
LumiraDx SARS-CoV-2 Ag Test |
EUA 8/18/2020 | Antigen | ||
|
LumiraDx |
LumiraDx SARS-CoV-2 RNA STAR |
EUA 8/11/2020, revoked 8/21/2024 | PCR | ||
| LumiraDx | Dual-Target SARS-CoV-2 STAR Complete | CE mark 6/2022 | PCR | ||
| LumiraDx | LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete | CE mark 6/2022 | PCR | ||
| Lumivi Diagnostics | SARS-CoV-2 IgG Rapid Test | Health Canada | Serological | ||
|
Maccura Biotechnology |
SARS-CoV-2 Fluorescent PCR Kit |
EUA 4/15/2020 | PCR | ||
|
Mammoth Biosciences |
SARS-CoV-2 DETECTR Reagent Kit |
CRISPR | |||
| Mammoth Biosciences | DETECTR Boost SARS-CoV-2 Reagent Kit | CRISPR | |||
|
Massachusetts General Hospital |
MGH COVID-19 qPCR assay |
EUA 4/3/2020 | PCR | ||
| MatMaCorp |
MatMaCorp COVID-19 2SF Test |
PCR | |||
| Maxim Biomedical | MaximBio ClearDetect COVID-19 Antigen Home Test | EUA 1/19/2022 | Antigen | ||
| 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 | |
| MedMira | REVEALCOVID-19 Plus Total Antibody Test | CE 2/2022 | Serological | ||
| Megna Health | Rapid COVID-19 IgM/IgG Combo Test Kit | EUA 7/17/2020 | Serological | ||
| Menarini Diagnostics | CoronaMelt Var | CE mark 7/2021 | PCR | ||
| Meridian Bioscience | Revogene SARS-CoV-2 assay | EUA 11/9/2021 | PCR | ||
| Mesa Biotech | Accula SARS-CoV-2 test | EUA 3/23/2020, revoked 5/22/2024 | PCR | ||
| MicroGem | MicroGem SAL6830 SARS-CoV-2 Salive test | EUA 4/14/2022 | PCR | ||
|
MicroGenDx (Southwest Regional PCR Laboratory) |
COVID-19 Key |
EUA 3/23/2020 | PCR | ||
|
MicrosensDx |
RapiProd LAMP SARS-CoV-2 test |
CE mark 3/2021 | Isothermal amplification | ||
| Minute Molecular Diagnostics | DASH SARS-CoV-2/S Test | EUA 3/15/2022 | PCR | ||
|
MiraDx |
MiraDx SARS-CoV-2 RT-PCR assay |
EUA 8/31/2020 | PCR | ||
|
Mobidiag |
Ampidiag Resp-4 |
CE mark 2/2021 | PCR | ||
|
Mobidiag |
Novodiag COVID-19 |
CE mark 6/2020 | PCR | ||
|
Mobidiag |
Amplidiag COVID-19 |
CE mark 6/2020 | PCR | ||
|
Mologic |
COVID-19 Rapid Antigen Test |
CE mark 12/2020 | Antigen | ||
| Mount Sinai Hospital, Center for Clinical Laboratories | Mount Sinai SARS-CoV-2 Assay | EUA 8/23/2021 | 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 | Health Canada 3/2021 | Serological | |
| Nano-Ditech | Nano-Check COVID-19 Antigen Test | EUA 12/6/2021 | Antigen | ||
|
NanoEntek America |
Frend COVID-19 Total Ab |
EUA 9/29/2020 | Serological | ||
| Nanomix | eLab COVID-19 test | CE mark 5/2022 | Antigen | ||
|
National Jewish Health |
SARS-CoV-2 MassArray Test |
EUA 9/29/2020 | PCR and mass spectrometry | ||
|
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 Flu A-B/RSV/SARS-CoV-2 Vantage Assay |
EUA 3/25/2021, revoked 5/24/2023 | PCR | ||
|
NeuMoDx Molecular |
NeuMoDx SARS-CoV-2 Assay |
EUA 3/30/2020 | CE mark 5/2020 | PCR | |
| Nexus Medical Labs | Nexus High Throughput SARS-CoV-2 Assay | EUA 5/17/2022 | PCR | ||
| New Gene (Hangzhou) Bioengineering | Novel Coronavirus Spike Glycoprotein Detection Kit | CE mark 5/2020 | Antigen | ||
| New Gene (Hangzhou) Bioengineering | Novel Coronavirus Antigen Detection Kit | CE mark 5/2020 | Antigen | ||
| New Gene (Hangzhou) Bioengineering | COVID-19 IgM/IgG Antibody Detection Kit | CE mark 5/2020 | Serological | ||
|
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 | ||
|
Nirmidas Biotech |
MidaSpot COVID-19 Antibody Combo Detection Kit |
EUA 12/31/2020 | Serological | ||
|
Northwestern Medicine Diagnostic Molecular Laboratory |
SARS-Cov-2 Assay |
EUA 4/2/2020 | PCR | ||
| Novacyt | PathFlow COVID-19 Rapid Antigen Self-Test | CE mark 6/2022 | Antigen | ||
| Novacyt | ProMate COVID-19 1G (q16) Real-Time PCR test | UK CTDA 6/2022 | PCR | ||
| Novacyt | SNPsig VariPlex | CE mark 3/2021 | PCR | ||
| Novacyt | Winterplex respiratory test panel | CE mark 8/2020 | PCR | ||
| Novacyt | COVID-HT Direct | CE mark 2/2021 |
|
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 Test | EUA 5/24/2021 | Serological | ||
| 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 | ||
| Oceanit | Assure-100 Rapid COVID-19 Test | EUA 2/28/2022 | Antigen | ||
|
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, revoked 2/14/2022 | 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 | ||
| OnsiteGene | Hi-Sense COVID-19 Molecular Testing Kit 1.0 | EUA 12/19/2022 | PCR | ||
|
Operon |
Simple/Stick Ag SARS-CoV-2 |
CE mark 1/15/2021 | Antigen | ||
|
Operon |
Real SARS-CoV-2 | CE mark 12/2020 | PCR | ||
|
Operon |
Real SARS-CoV-1/2 | CE mark 10/2020 | PCR | ||
|
OpGen |
SARS-CoV-2 Kit with PULB | CE mark 8/2020 | PCR | ||
| Opti Medical Systems/Idexx Laboratories | Opti SARS-CoV-2/Influenza A/B RT-PCR Test | EUA 4/21/2022 | CE mark 3/2021 | PCR | |
| Opti Medical Systems/Idexx Laboratories | Opti SARS-CoV-2 Total Antibody Test | CE mark 1/2021 | Serological | ||
|
Opti Medical Systems/Idexx Laboratories |
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 | |
| OraSure Technologies | InteliSwab COVID-19 Rapid Test |
EUA 6/4/2021, reissued 1/31/2022 |
Antigen | ||
| OraSure Technologies | InteliSwab COVID-19 Rapid Test Pro |
EUA 6/4/2021, reissued 1/31/2022 |
Antigen | ||
| OraSure Technologies | InteliSwab COVID-19 Rapid Test Rx |
EUA 6/4/2021, reissued 1/31/2022 |
Antigen | ||
|
Orig3n |
Orig3n 2019 Novel Coronavirus (COVID-19) Test |
EUA 4/10/2020 | PCR | ||
| Ortho Clinical Diagnostics | Vitros Anti-SARS-CoV-2 Total N Reagent Pack with Total N Antibody Calibrators | EUA 7/22/2021 | Serological | ||
| Ortho Clinical Diagnostics | Vitros Anti-SARS-CoV-2 IgG Quantitative test | EUA 7/9/2021 | Serological | ||
| Ortho Clinical Diagnostics | Vitros Anti-SARS-CoV-2 IgG Quantitative Antibody assay | CE mark 5/2021 | Serological | ||
|
Ortho Clinical Diagnostics |
Vitros Anti-SARS-CoV-2 IgG 2 Antibody assay |
CE mark 3/2021 | Serological | ||
|
Ortho Clinical Diagnostics |
Vitros Anti-SARS-CoV-2 Total 2 Antibody assay |
CE mark 3/2021 | Serological | ||
|
Ortho Clinical Diagnostics |
Vitros SARS-CoV-2 Antigen test |
EUA 1/10/2021 | CE mark 10/2020, 4/2021 | 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, revoked 2/2/2024 |
CE mark 5/2020 | Serological | |
| Ortho Clinical Diagnostics |
Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack/Calibrator |
EUA 4/24/2020, revoked 2/2/2024 |
Serological | ||
| Osang Healthcare | GeneFinder COVID-19 Plus RealAmp Kit | EUA 4/18/2020 | CE mark 2/2020 | PCR | |
| Osang Healthcare | OHC COVID-19 Antigen Self Test | EUA 4/6/2022 | Antigen | ||
| 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 Quadriplex (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 | ||
| PathogenDx | DetectX-Rv | EUA 4/20/2021 | CE mark 7/2021 | PCR | |
| PathogenDx | DetectX-Cv+ | CE mark 2/2022 | PCR, microarray | ||
|
Patients Choice Laboratories |
PCL SARS-CoV-2 Real-Time RT-PCR Assay |
EUA 8/28/2020 | PCR | ||
| Pelican Diagnostics |
Pelican COVID-19 Ultra-Rapid Mobile Test |
CE mark 3/2021 | Antigen | ||
| PerkinElmer |
PerkinElmer COVID-19 Antigen Test |
CE mark 2/2021 | Antigen | ||
| PerkinElmer |
PKamp Respiratory SARS-CoV-2 RT-PCR Panel |
EUA 10/6/2021 | 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 Asssay |
CE mark 11/2020 | PCR | ||
| PerkinElmer |
SARS-CoV-2 RT-qPCR Reagent Kit |
EUA 4/12/2021, revoked 1/30/2024 | CE mark 4/2020 | PCR | |
| PerkinElmer |
PerkinElmer New Coronavirus Nucleic Acid Detection Kit |
EUA 3/24/2020, reissued 10/28/2020 | PCR | ||
| Phadia (Thermo Fisher Scientific) |
EliA SARS-CoV-2-Sp1 IgG Test |
EUA 1/11/2021 | Serological | ||
| Phase Scientific International | Indicaid COVID-19 Rapid Antigen Test | EUA 7/28/2021 | Antigen | ||
| Phase Scientific International | Indicaid COVID-19 Rapid Antigen At-Home Test | EUA 3/16/2022 | Antigen | ||
| Phosphorus Diagnostics |
Phosphorus COVID19 RT-qPCR Test DTC |
EUA 5/17/2021 | PCR | ||
| Phosphorus Diagnostics | Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC | EUA 5/17/2021 | Collection kit | ||
| Phosphorus Diagnostics |
Phosphorus COVID-19 RT-qPCR Test |
EUA 6/4/2020, reissued 12/15/2020 | PCR | ||
| Pictor | PictArray SARS-CoV-2 IgG | CE mark 6/2022 | Serological | ||
| 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 | ||
| Precision Biosensor | Exdia COVID-19 IgG/IgM |
CE mark 6/2020 |
Serology | ||
| Precision Biosensor | Exdia COVID-19 Ag | CE mark 9/2020 |
Korea Ministry of Food and Drug Safety 8/2021 FDA Thailand 4/2021 |
Antigen | |
| Precision Biosensor | PBCheck COVID-19 IgG/IgM | CE mark 6/2020 | Serology | ||
| Precision Biosensor | PBCheck COVID-19 Ag | CE mark 10/2020 |
Korea Ministry of Food and Drug Safety 8/2021 Philippines FDA 1/2022 Roszdravnadzor (Russian Federation) 4/2021 |
Antigen | |
| Premier Medical Laboratory Services | PMLS SARS-CoV-2 Assay | EUA 1/7/2022 | PCR | ||
| Prenetics | Circle HealthPod | CE mark 7/2021 | PCR | ||
|
Princeton BioMeditech |
Status COVID-19/Flu |
EUA 2/4/2021 | Antigen | ||
|
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 | ||
| Promega | Lumit Dx SARS-CoV-2 Immunoassay | CE mark 6/2021 | Serological | ||
| 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 | Qiareach SARS-CoV-2 Antigen Test | EUA 8/2021 | Antigen | ||
| Qiagen | Qiareach Anti-SARS-CoV-2 Total Test | EUA 5/11/2021 | Serological | ||
| Qiagen |
Artus SARS-CoV-2 Prep&Amp UM Kit |
CE mark 4/2021 | PCR | ||
| Qiagen | QiaStat-Dx Respiratory SARS-CoV-2 Panel | EUA 3/30/2020 | CE mark 3/2020 | PCR | |
| Qlife Aps | Egoo SARS-CoV-2 POC test | CE mark 1/2021 | Isothermal amplification | ||
| Qorvo Biotechnologies |
Omnia SARS-CoV-2 Antigen Test |
EUA 4/13/2021 | Antigen | ||
| 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 | ||
| Quanterix |
Simoa SARS-CoV-2 N Protein Antigen Test |
EUA 1/5/2021, revoked 5/10/2022 | Antigen | ||
| Quanterix | Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test | EUA 12/23/2020, revoked 5/10/2022 | Serological | ||
| QuantuMDx | Q-POC SARS-CoV-2, Flu A/B & RSV Assay | CE mark 5/2022 | PCR | ||
| QuantuMDx | SARS-CoV-2 RT-PCR Detection Assay | CE mark 6/2020 | PCR | ||
| Quest Diagnostics Infectious Disease | Quest Diagnostics Collection Kit for COVID-19 | EUA 10/8/2021 | Collection kit | ||
| 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 | ||
| Quest Diagnostics Nichols Institute | Quest COVID-19 PCR DTC | EUA 3/21/2022 | PCR | ||
| Quest Diagnostics Nichols Institute | Quest PF COVID-19 PCR DTC | EUA 3/21/2022 | PCR | ||
| Quest Diagnostics Nichols Institute | Quest RC COVID-19 PCR DTC | EUA 3/21/2022 | PCR | ||
| Quest Diagnostics Nichols Institute | Quest COVID-19 PCR Test Home Collection Kit | EUA 3/21/2022 | Collection kit | ||
| Quidel |
QuickVue At-Home OTC COVID-19 Test |
EUA 3/31/2021 | Antigen | ||
| Quidel |
QuickVue At-Home COVID-19 Test |
EUA 3/1/2021 | Antigen | ||
| Quidel |
Solana SARS-CoV-2 Assay |
EUA 12/23/2020 | Isothermal amplification | ||
| 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 Magazine |
EUA 9/25/2020, revoked 1/11/2022 | 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 Nucleic Acid Test (for Cobas Liat system) | EUA 6/17/2021, revoked 8/5/2024 | PCR | ||
| Roche | SARS-CoV-2 Antigen Self Test Nasal | CE mark 6/2021 | Antigen | ||
| Roche |
Cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test (for Cobas Liat system) |
EUA 9/14/2020, revoked 7/3/2024 | 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, reissued 10/15/2020 |
CE mark 2020 | PCR | |
| Roche | Cobas SARS-CoV-2 Duo | EUA 6/14/2022 | PCR | ||
|
RTA Laboratories |
Diagnovital SARS-CoV-2 Real-Time PCR Kit |
EUA 6/12/2020, revoked 3/14/2022 | PCR | ||
|
Rutgers University Clinical Genomics Laboratory |
ThermoFisher - Applied Biosystems TaqPath COVID-19 Combo Kit |
EUA 4/10/2020, amended 5/7/2020 | PCR | ||
| Sacace Biotechnologies | SARS-CoV-2 Real-TM | CE mark 4/2020 | PCR | ||
| Salofa | Sienna-Clarity COVID-19 Antigen Rapid Test Cassette | EUA 5/20/2021 | Antigen | ||
|
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, revoked 6/7/2022 | PCR | ||
| Scope Fluidics/Curiosity Diagnostics | PCR One SARS-CoV-2 panel | CE mark 7/2021 | PCR | ||
| SD Biosensor/Roche | COVID-19 At-Home Test | EUA 12/24/2021 | Antigen | ||
| SD Biosensor/Roche |
SARS-CoV-2 Rapid Antigen Test Nasal |
CE mark 2/2021 | Antigen | ||
| SD Biosensor/Roche |
SARS-CoV-2 Rapid Antigen Test |
CE mark 9/2020 | Antigen | ||
| 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 | Combo Swab | CE mark 8/2021 | Collection swab | ||
| 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 |
| Seegene | Allplex SARS-CoV-2 fast MDx Assay | CE mark 2/2022 | Isothermal amplification | ||
| Seegene | Allplex RV Master Assay | CE mark 4/2022 | Australian Register of Therapeutic Goods approval | PCR | |
| Sense Biodetection | Veros COVID-19 | CE mark 3/2022 | Isothermal amplification | ||
|
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 | ||
| SG Diagnostics | COVID-19 IgG/IgM Rapid Test Kit | CE mark 12/2020 | Serological | ||
| SG Diagnostics | COVID-19 Triplex RT-qPCR Detection Kit | CE mark 12/2020 | PCR | ||
| SG Diagnostics | Influenza A/B + COVID-19 Rapid Test Kit | CE mark 12/2020 | Antigen | ||
| SG Diagnostics | COVID-19 Immunity Rapid Test Kit (anti-Nucleocapsid Protein IgG) | CE mark 2/2021 | Serological | ||
| SG Diagnostics | COVID-19 ELISA Test | CE mark 2/2021 | Serological | ||
| SG Diagnostics | COVID-19 Immunity Strength Semi-Quantitative Detection Kit (Quantum Dot Fluorescence Immunoassay) | CE mark 7/2021 | Serological | ||
| SG Diagnostics | COVID-19 Dual Immunity Rapid Test Kit (anti-Spike RBD IgG and anti-Nucleocapsid Protein IgG Antibody) | CE mark 7/2021 | Serological | ||
| SG Diagnostics | COVID-19 Immunity Rapid Test Kit (anti-Spike RBD IgG Antibody) | CE mark 7/2021 | Serological | ||
| SG Diagnostics | COVID-19 Saliva Antigen Rapid Test Kit | CE mark 7/2021 | Antigen | ||
| SG Diagnostics | SG Diagnostics COVID-19 Immunity Strength Rapid Test Kit (RBD Neutralizing Antibody) | CE mark 4/2021 | Serological | ||
|
SG Diagnostics |
SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based) |
CE mark 12/2020 | Singapore Health Sciences Authority 1/2021 | Antigen | |
|
Shanghai Fosun Long March Medical Science/Shanghai Fosun Pharmaceutical |
novel coronavirus nucleic acid detection kit |
CE mark 3/2020 | China NMPA 3/2020 | PCR | |
|
Shanghai GeneSc Biotech |
LAMP Based Coronavirus 2019-nCoV Rapid Detection Kit |
CE mark 9/2020 | Isothermal amplification | ||
|
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 | ||
| Shuwen Biotech |
SARS-COV-2 RT-PCR Kit |
CE mark 1/2021 | PCR | ||
| Siemens Healthineers | Clinitest Rapid COVID-19 Antigen Self-Test | EUA 12/29/2021 | Antigen | ||
| Siemens Healthineers | Advia Centaur SARS-CoV-2 IgG (sCOVG) | EUA 6/17/2021 | Serological | ||
| Siemens Healthineers |
SARS-CoV-2 Antigen Assay (CoV2Ag) |
CE mar 2/2021 | Antigen | ||
| Siemens Healthineers |
Atellica IM SARS-CoV-2 IgG (sCOVG) |
EUA 3/23/2021 | Serological | ||
| Siemens Healthineers |
Dimension EXL SARS‑CoV‑2 IgG (CV2G) |
EUA 1/8/2021 | Serological | ||
| Siemens Healthineers |
Dimension EXL SARS‑CoV‑2 IgG (COV2G) |
EUA 1/8/2021 | Serological | ||
| 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, revoked 12/17/2021 | Serological | ||
| Siemens Healthineers | Atellica IM SARS-CoV-2 Antigen (CoV2Ag) | EUA 3/11/2022 | Antigen | ||
| 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, revoked 12/17/2021 | Serological | ||
| Siemens Healthineers | Advia Centaur SARS-CoV-2 Antigen (CoV2Ag) | EUA 3/11/2022 | Antigen | ||
| 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, revoked 4/18/2024 | CE mark 4/2020 | PCR | |
| SML Genetree |
Ezplex SARS-CoV-2 G Real-Time PCR Kit |
EUA 1/13/2021 | PCR | ||
| Snibe Diagnostic | Maglumi SARS-CoV-2 Ag | CE mar 2/2021 | Antigen | ||
| Snibe Diagnostic | Maglumi SARS-CoV-2 Neutralizing Antibody Assay | CE mark 1/2021 | Serological | ||
| Snibe Diagnostic | Maglumi 2019-nCoV (SARS-CoV-2) IgM/IgG kits | CE mark 2/2020 | Serological | ||
| Snibe Diagnostic |
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 | CE mark 12/2020 | Antigen | |
|
Sorrento Therapeutics |
COVI-Track Diagnostic Test |
EUA submission pending | Serological | ||
| Southern California Permanente Medical Group | Kaiser Permanente High Throughput SARS-CoV-2 Assay | EUA 4/19/2021, revoked 9/29/2023 | PCR | ||
|
Specialty Diagnostic (SDI) Laboratories |
SDI SARS-CoV-2 Assay |
EUA 4/10/2020 | PCR | ||
| Spectrum Solutions | SDNA-2000, SDNA-3000 Saliva Collection Devices | CE mark 1/2021 | Collection device | ||
| Spectrum Solutions | SDNA-1000 Saliva Collection Device | EUA 10/8/2020 | Collection device | ||
| SpeeDx | PlexPCR SARS-CoV-2 test | CE mark 4/2021 | Australian Therapeutic Goods Administration (TGA) clearance 8/21 | PCR | |
| 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 | ||
| Symbiotica |
COVID-19 Self-Collected Antibody Test System |
EUA 4/5/2021 |
|
Serological | |
| Synergy Diagnostic Laboratory |
SynergyDx SARS-CoV-2 RNA Test |
EUA 4/16/2021 |
|
PCR | |
| Synergy Diagnostic Laboratory |
SynergyDx SARS-CoV-2 RNA Test DTC |
EUA 4/16/2021 |
|
PCR | |
| 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 | ||
| Takara Bio Europe | Takara SARS-CoV-2 Direct PCR detection kit | CE mark 9/2021 | PCR | ||
| Talis Biomedical | Talis One COVID-19 Test System | EUA 11/5/2021, EUA revoked 8/23/2022 | Isothermal amplification | ||
| Tangen Biosciences | TangenDx SARS-CoV-2 Molecular Test | EUA 9/29/2023, revoked 1/17/2024 | Isothermal amplification | ||
| 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 | ||
| Therma Bright | AcuVid COVID-19 Rapid Antigen Saliva Test | CE mark 4/2021 | Antigen | ||
| Thermo Fisher Scientific | TaqPath COVID-19 MS2 Combo Kit 2.0 | PCR | |||
| Thermo Fisher Scientific | TaqPath COVID-19 Fast PCR Combo Kit 2.0 | EUA 7/30/2021 | PCR | ||
| Thermo Fisher Scientific | TaqPath COVID-19 RNase P Combo Kit 2.0 | EUA 7/8/2021 | CE mark 9/2021 | PCR | |
| Thermo Fisher Scientific | TaqPath COVID-19 Pooling Kit | EUA 5/25/2021, revoked 1/16/2024 | PCR | ||
| Thermo Fisher Scientific |
Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit |
EUA 4/9/2021 | 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, revoked 4/13/2023 | CE mark 10/2020 | Serological | |
| Thermo Fisher Scientific |
Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit |
EUA 2/10/2021 | PCR | ||
| Thermo Fisher Scientific |
Applied Biosystems TaqPath COVID–19 HT Kit |
CE mark 1/2021 | PCR | ||
| Thermo Fisher Scientific |
TaqPath COVID-19 Combo Kit, RT-PCR CE-IVD Kit |
EUA 3/13/2020 (Combo kit), reissued 10/9/2020 | 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 Peptide Nucleic Acid (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 | ||
|
Trinity Biotech |
Captia(TM) SARS-CoV-2 IgG ELISA |
CE mark 1/2021 | Serological | ||
|
Twist Bioscience |
SARS-CoV-2 NGS Assay |
EUA 3/23/2021, revoked 2/14/2023 | Sequencing | ||
|
UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin |
SARS-CoV-2 RNA DETECTR Assay |
EUA 7/9/2020 | CRISPR | ||
| Uh-Oh Labs | UOL COVID-19 Test | EUA 2/8/2022 | Isothermal amplification | ||
|
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 | ||
|
United Biomedical |
UBI SARS-CoV-2 ELISA | EUA 1/15/2021 | Serological | ||
|
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 |
Serological | |||
|
University of California, Los Angeles |
UCLA SwabSeq COVID-19 Diagnostic Platform |
EUA 10/6/2020 | PCR | ||
| University of California San Diego BCG Excite Lab | UCSD Excite COVID-19 Test | EUA 12/17/2021 | PCR | ||
| University of California San Diego BCG Excite Lab | UCSD Excite COVID-19 EL Test | EUA 4/7/2022 | PCR | ||
|
University of California San Diego Health |
UCSD RC SARS-CoV-2 Assay |
EUA 7/31/2020 | PCR | ||
|
University of Illinois |
CovidShield |
EUA 2/24/2021 | PCR | ||
|
University of North Carolina Medical Center |
UNC Health SARS-CoV-2 real-time RT-PCR test |
EUA 4/10/2020 | PCR | ||
|
University of Pennsylvania |
BD MAX COVID-19 Assay |
EUA 1/19/2021 | 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 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 | |
|
Verify Diagnostics |
Assure Tech Ecotest COVID-19 |
|
Health Canada authorization 2/2021 | Serological | |
|
Verily Life Sciences |
Verily COVID-19 RT-PCR Test |
EUA 9/8/2020, reissued 12/18/2020, revoked 6/21/2023 |
PCR | ||
|
Vibrant America Clinical Labs |
Vibrant COVID-19 Ab Assay | EUA 6/4/2020 | Serological | ||
|
Viracor Eurofins |
Viracor SARS-CoV-2 assay DTC | EUA 2/26/2021 | PCR | ||
|
Viracor Eurofins |
Viracor SARS-CoV-2 assay | EUA 4/6/2020 | PCR | ||
|
Visby Medical |
Visby Medical COVID-19 Point of Care Test | EUA 2/8/2021 | 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 Saliva Test Collection Kit DTC | EUA 6/17/2021 | Collection device | ||
| Wren Laboratories | Wren Laboratories COVID-19 PCR Test DTC | EUA 6/17/2021 | 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 Boson Biotech | Rapid SARS-CoV-2 Antigen Test Card | EUA 4/6/2022 | Antigen | ||
|
Xiamen Wiz Biotech |
Diagnostic Kit (Colloidal Gold) for 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 | ||
|
XPhyto Therapeutics/3a-Diagnostics |
Covid-ID Lab |
CE mark 3/2021 | PCR | ||
| Xtrava Health | Spera COVID-19 Ag Test | EUA 10/12/2021, revoked 8/3/2023 | Antigen | ||
|
Yale New Haven Hospital Clinical Virology Laboratory |
SARS-CoV-2 PCR test |
EUA 3/31/2020 | PCR | ||
| Yale School of Public Health | SalivaDirect for use with DTC Kits | EUA 8/27/2021 | Collection device | ||
| Yale School of Public Health | SalivaDirect DTC Saliva Collection Kit | EUA 8/27/2021 | Collection device | ||
|
Yale School of Public Health |
SalivaDirect At-Home Collection Kit |
Collection device | |||
|
Yale School of Public Health |
SalivaDirect |
EUA 8/15/2020, reissued 8/28/2020, reissued 12/16/2020 |
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 ELIS SARS-CoV-2 Total Antibody Test System | EUA 5/11/2021 | Serological | ||
|
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 | SafeCollect Sample Collection Kit | CE mark 8/2021 | Collection device | ||
|
Zymo Research |
DNA/RNA Shield Collection Tube |
510(k) clearance 12/14/2020 | Collection device | ||
|
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 |