| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: InDevR Inc. | Commercial: COVID Serology Kit: Multiplexed Immunoassay | Device ID: 225 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: ARUP Laboratories | Commercial: COVID-19 | Device ID: 702 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Fulgent Genetics/MedScan Laboratory | Commercial: COVID-19 | Device ID: 166 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: MedicalSystem Biotechnology Co. Ltd. | Commercial: COVID-19 Ag Rapid Test Cassette | Device ID: 2049 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: FemtoDx | Commercial: COVID-19 Antibody Test | Device ID: 164 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: SPAN BIOTECH Ltd. | Commercial: Covid-19 Antigen Rapid Test Cassette | Device ID: 2787 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Nanjing Liming BioProducts Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Device | Device ID: 681 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Diagnostic Solutions Laboratory | Commercial: COVID-19 Assay | Device ID: 146 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: BioRad | Commercial: COVID-19 Droplet Digital PCR (ddPCR) Assay | Device ID: 755 | Method: Digital-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Mount Sinai Labs | Commercial: COVID-19 ELISA IgG Antibody Test | Device ID: 738 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Biomeme | Commercial: COVID-19 Go Strips | Device ID: 91 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Anbang (Xiamen) Biotechnology Co. Ltd. | Commercial: COVID-19 Hybrid Capture Fluorescence Immunoassay Test | Device ID: 32 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Eagle Biosciences Inc. | Commercial: COVID-19 IgG ELISA Assay | Device ID: 154 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Invenio Medical | Commercial: COVID-19 IgG/IgM Ab Rapid Test | Device ID: 1635 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Biogate Laboratories Ltd. | Commercial: COVID-19 IgG/IgM Ab Rapid Test | Device ID: 776 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Verify Diagnostics Inc. | Commercial: Covid-19 IgG/IgM Antibody Test | Device ID: 628 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. | Commercial: COVID-19 IgG/IgM Combined Test kit(Colloidal Gold Method) | Device ID: 995 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Eco Diagnostica Ltd.a | Commercial: COVID-19 IgG/IgM ECO Teste | Device ID: 672 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Advagen Biotech Ltd. | Commercial: COVID-19 IgG/IgM LF | Device ID: 818 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Assut Europe | Commercial: Covid-19 IgG/IgM RAPID TEST | Device ID: 1036 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: AIVD Biotech Inc. | Commercial: COVID-19 IgG/IgM Rapid Test (colloidal gold-based) | Device ID: 18 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Shenzhen Landwind Medical | Commercial: COVID-19 IgG/IgM Rapid Test Device | Device ID: 691 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Eagle Biosciences Inc. | Commercial: COVID-19 IgM ELISA Assay | Device ID: 153 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: MicroGenDx | Commercial: COVID-19 Key | Device ID: 737 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Abbott | Commercial: COVID-19 LAB TEST TO DETECT ANTIBODIES | Device ID: 754 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: STILLA | Commercial: COVID-19 Multiplex Crystal Digital PCR detection kit | Device ID: 382 | Method: Digital-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Navid | Commercial: COVID-19 Nucleic Acid Detection Kit (Rapid PCR Fluorescence Method) | Device ID: 326 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Xi'an Tianlong Science and Technology Co. Ltd. | Commercial: COVID-19 ORF1ab/N Gene PCR Detection Kit | Device ID: 442 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Dynamic Code AB | Commercial: Covid-19 PCR | Device ID: 2550 | Method: RT-PCR | Target: | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: University of North Carolina Medical Center McLendon Clinical Laboratories | Commercial: COVID-19 PCR, on WHO protocol | Device ID: 414 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: FemtoDx | Commercial: COVID-19 Rapid Home Nucleic Acid Test | Device ID: 165 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Wondfo | Commercial: COVID-19 Rapid Test, WONDFO SARS-CoV-2 Antibody Test (Lateral Flow Method) | Device ID: 687 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: SNP Biotechnology R&D Ltd. Co. | Commercial: COVID-19 Real Time PCR Kit | Device ID: 809 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Phosphorus Diagnostics | Commercial: COVID-19 RT-qPCR Test | Device ID: 1407 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: UPMC | Commercial: COVID-19 test | Device ID: 416 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Anhui Hua Pei Biotechnology Co. Ltd. | Commercial: COVID-19 Virus Antigen Detection Kit（Fluorescence Immunochromatography Assay） | Device ID: 2375 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: No | Manufacturer: Pharmatech | Commercial: COVID19 IgG/IgM Rapid Test | Device ID: 686 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Novus Biologicals | Commercial: COVID19 IgG/IgM Rapid Test Kit | Device ID: 685 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: CoviDx | Device ID: 350 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Curative Inc. (in conjunction with KorvaLabs Inc) | Commercial: Curative-Korva SARS-Cov-2 Assay | Device ID: 536 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: DART Diagnostics | Commercial: DART COVID-19 | Device ID: 145 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Guangdong Huayin Medicine Science Co. Ltd. | Commercial: Detection Kit for 2019-nCoV RNA (RT-PCR Fluorescence Probing) (Lyophilised) | Device ID: 194 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: EMG | Commercial: Detection Kit for the SARS-CoV-2 RNA Presence in Biological Material Using Real-Time (RUO) | Device ID: 782 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Microdiag Biomedicine Technology Co. Ltd. | Commercial: Detection of 2019 novel coronavirus (2019-nCoV) by LFD RT-RAA | Device ID: 237 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Lionrun | Commercial: Diagnostic kit for antibody IgM/IgG of Novel Coronavirus COVID-19 | Device ID: 1633 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Zhuhai Livzon Diagnostics Inc. | Commercial: Diagnostic Kit for Nucleic Acid to nCoV-2019 (PCR- Fluorescence Probe) | Device ID: 457 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Diasia Biomedical Technology Co. Ltd. | Commercial: Diagnostic Kit for SARS-CoV-2 Nucleic Acid(RT-PCR) | Device ID: 2140 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: No | Manufacturer: Diazyme Laboratories | Commercial: Diazyme DZ-LITE SARS-CoV-2 IgG | Device ID: 670 | Method: Immunoassay | Target: Antibody, IgG | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Diazyme Laboratories | Commercial: Diazyme DZ-LITE SARS-CoV-2 IgM CLIA kit | Device ID: 1416 | Method: CLIA | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Chembio Diagnostic Systems | Commercial: DPP COVID-19 IgM/IgG System | Device ID: 669 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | 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