| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Mobidiag | Commercial: Novodiag COVID-19 + InfA/B | Device ID: 283 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: OFM Medical | Commercial: OFM GmbH | Device ID: 2202 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Hangzhou Testsea Biotechnology Co. Ltd. | Commercial: One Step SARS-nCoV2 (COVID-19) IgG/IgM test | Device ID: 676 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: MedStar Medical Co. Ltd. | Commercial: One-step Direct Realtime PCR Test Kit of 2019-nCoV Coronavirus | Device ID: 278 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: CTK Biotech Inc. | Commercial: OnSite COVID-19 IgG/IgM | Device ID: 535 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Orig3n | Commercial: Orig3n 2019 Novel Coronavirus (COVID-19) Test | Device ID: 742 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: PRIME4DIA Co. Ltd. | Commercial: P4DETECT COVID-19 IgM/IgG | Device ID: 320 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: PRIME4DIA Co. Ltd. | Commercial: P4DETECT COVID-19 SAg | Device ID: 319 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Integrated Nano-Technologies | Commercial: Palladium | Device ID: 656 | Method: Other | Target: Other | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Aldatu Biosciences | Commercial: PANDAA qDx SARS-CoV-2 | Device ID: 20 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Hologic | Commercial: Panther Fusion SARS-CoV-2 assay | Device ID: 217 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Scope Fluidics SA | Commercial: PCR|COV | Device ID: 604 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Labormed Tıbbi Ãœrünler San Ve Tic Ltd. ÅžTÄ° | Commercial: Pekit Covid-19 Rapid (Hızlı) Antigen Test | Device ID: 3010 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd. | Commercial: PerfectQ COVID-19 Coronavirus Real Time PCR Kit | Device ID: 234 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Nirmidas Biotech Inc. | Commercial: pGOLD COVID-19 IgG/IgM/IgA Microarray Test | Device ID: 793 | Method: Other | Target: Antibody, IgA, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Caspr Biotech | Commercial: Phantom 1.0 Dx (near POC) | Device ID: 115 | Method: CRISPR | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Pinpoint Science Inc. | Commercial: Pinpoint Covid-19 Screening Assay – Electrical detection of SARS-CoV-2 nucleocapsid protein using nanosensors and aptamer | Device ID: 312 | Method: Other | Target: Other | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: PlexBio Co. Ltd. | Commercial: PlexBio CoVid19/SARS/Influenza A, B Detection kit | Device ID: 313 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: GeneReach Biotechnology Corporation | Commercial: POCKIT Central SARS-CoV-2 (orf 1ab) Premix Reagent | Device ID: 180 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: No | Manufacturer: Canvax Biotech | Commercial: qMAXSen Coronavirus (SARS-CoV-2) RT-qPCR Detection Kit | Device ID: 470 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: PCR BioSystems | Commercial: qPCRbio Probe 1-step-go Kit | Device ID: 887 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: CellSafe | Commercial: Qplex COVID-19 RT-qLAMP Assay | Device ID: 118 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: QuantuMDx Group Ltd. | Commercial: QPOC Point of Care NAT for SARS-CoV-2 | Device ID: 329 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: BillionToOne Inc. | Commercial: qSanger-COVID-19 Assay | Device ID: 1401 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Huwel Lifesciences Pvt. Ltd. | Commercial: Quantiplus CORONA Virus (2019nCoV) detection kit | Device ID: 222 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Attomarker Ltd. | Commercial: Quantitative Immuno-kinetic assay for Covid-19 IgG+IgM+IgA for a multiantigen panel with CRP | Device ID: 44 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: QuantuMDx Group Ltd. | Commercial: QuantuMDx NAT for SARS-CoV-2 | Device ID: 328 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Aura Biotechnologies Ltd. | Commercial: Quick COVID-19 Colorimetric LAMP PCR | Device ID: 516 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Aura Biotechnologies Ltd. | Commercial: Quick COVID-19 Realtime Multiplex PCR | Device ID: 517 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Denka Seiken Co. Ltd. | Commercial: QuickNavi-COVID19 | Device ID: 780 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Tianjin New Bay Bioresearch C | Commercial: Quik Pac II COVID-19 IgG & IgM Test | Device ID: 1631 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: QuikPath Pte Ltd. | Commercial: QuikPath Covid-19 POC molecular test | Device ID: 599 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Abwiz Bio | Commercial: RabWiz Ultra Sensitive COIV-19 Viral Antigen Test Kit (ELISA) | Device ID: 10 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: RainSure Scientific Co. Ltd. | Commercial: RainSure COVID-19 dPCR Detection Kit (lab-based) | Device ID: 333 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Nirmidas Biotech Inc. | Commercial: Rapid COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit | Device ID: 297 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Healgen Scientific | Commercial: Rapid COVID-19 AntigenTest | Device ID: 1612 | Method: CLIA | Target: Antigen | Format: | Go to details |
| CE Marking: No | Manufacturer: Sherlock Biosciences | Commercial: Rapid CRISPR-based tests for SARS-CoV-2 and other pathogens | Device ID: 645 | Method: CRISPR | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 110 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Rapid Bio LLC | Commercial: Rapid test for IgM/IgG antibodies against SARS-COV-2 | Device ID: 601 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Landcent Europe B.V. | Commercial: Real time RT-PCR Kit for the detection of SARS-CoV-2 | Device ID: 256 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Suzhou BTA Biotech Co. Ltd. | Commercial: Real time RT-PCR Kit for the detection of SARS-CoV-2 | Device ID: 393 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Sigmed Sp. z o.o. | Commercial: Redtest SARS-CoV-2 Antigen Rapid Test (Covid-19 Ag) | Device ID: 2328 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: BioRad | Commercial: Reliance One-Step RT-qPCR Supermix | Device ID: 757 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS CoV-2 Antigen ELISA Kit | Device ID: 449 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS CoV-2 Antigen Rapid Test | Device ID: 448 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS CoV-2 IgM ELISA Kit | Device ID: 447 | Method: ELISA | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS Pan-Corona Antigen ELISA Kit | Device ID: 446 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS Pan-Corona IgM ELISA Kit | Device ID: 450 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS Pan-Corona Rapid Test | Device ID: 445 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GeneFirst Ltd. | Commercial: Respiratory Pathogen Panel | Device ID: 176 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements