| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: BMT Diagnostics | Commercial: Lab-On-Time COVID-19 Antigen Rapid Test Device (Integrated Throat Swab) | Device ID: 1605 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BN Santé | Commercial: COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) | Device ID: 1830 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BN Santé | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) | Device ID: 1828 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BN Santé | Commercial: SARS-CoV-2 Antigen Rapid test | Device ID: 1964 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: BN Santé | Commercial: SARS-CoV-2 IgG/IgM Rapid Test | Device ID: 2194 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: AFIAS COVID-19 Ab, IgM/IgG | Device ID: 836 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: AFIAS COVID-19 Ag | Device ID: 1989 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: AFIAS COVID-19 nAb | Device ID: 2399 | Method: Immunoassay | Target: Antibody | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: AFIAS COVID-19 SP/NP IgG | Device ID: 2783 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: AFIAS COVID-19, Viral Antigen | Device ID: 105 | Method: Immunoassay | Target: Antigen | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: AFIAS COVID-19, Viral Antigen (automated) | Device ID: 1248 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: AFIAS COVID-19/Flu Ag Combo | Device ID: 1449 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: Boditech Quick™ COIVD-19 Ag | Device ID: 2413 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: Boditech Quick™ COVID-19 Neutralizing Ab | Device ID: 2785 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: ExAmplar COVID-19 real-time PCR kit (L) | Device ID: 104 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: ExAmplex Influenza A/B SARS-CoV-2 PCR kit | Device ID: 1450 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: ichroma COVID-19/Flu Ag Combo | Device ID: 1448 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: Ichroma COVID-19 Ab, IgM/IgG | Device ID: 837 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: Ichroma COVID-19, viral Antigen | Device ID: 107 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: ichroma™ COVID-19 Ag | Device ID: 1990 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: ichroma™ COVID-19 nAb | Device ID: 2398 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: ichroma™ COVID-19 SP/NP IgG | Device ID: 2784 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: NuActor - Viral extraction kit | Device ID: 1135 | Method: Other | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: BOME TRIVITRON | Commercial: TRIMARIS SARS-CoV-2 RT-qPCR Kit | Device ID: 2259 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Bosch Healthcare Solutions | Commercial: Vivalytic SARS-CoV-2 Pooling | Device ID: 2976 | Method: RT-PCR | Target: | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bosch Healthcare Solutions GmbH | Commercial: Vivalytic SARS-CoV-2 | Device ID: 2977 | Method: RT-PCR | Target: | Format: Automated, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Boston Children's Hospital Infectious Diseases Diagnostic Laboratory (IDDL) | Commercial: Childrens-Altona-SARS-CoV-2 assay | Device ID: 712 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Bright Line Research | Commercial: Rona 19 Screen Coronavirus (SARS-CoV-2) IgG/IgM Rapid Test | Device ID: 109 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Broad Institute | Commercial: STOPCovid kit | Device ID: 759 | Method: Other | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 Antigen Rapid Test | Device ID: 1236 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 Antigen Rapid Test Cassette (Oral Fluid) | Device ID: 1684 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 IgG/IgM Rapid Test Device | Device ID: 2033 | Method: Immunochromatography | Target: Antibody, IgG, IgM | 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: Yes | Manufacturer: C4Diagnostics | Commercial: C4Covid-19 Human | Device ID: 2465 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: CALTH Inc. | Commercial: AllCheck COVID19 Ag | Device ID: 1647 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CALTH Inc. | Commercial: AllCheck COVID19 Ag Nasal | Device ID: 2691 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CAMP MEDICA DISTRIBUTION | Commercial: See Now Coronavirus nCoV antigen test | Device ID: 1999 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Camtech | Commercial: Camtech COVID-19 Rapid Test Kit | Device ID: 111 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Camtech | Commercial: COVID-19 Viral Antigen Test Kit | Device ID: 1237 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Canary Global Inc. | Commercial: DigiGENE™ COVID-19 Integrated Molecular Test | Device ID: 2948 | Method: LAMP | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Canary Global Inc. | Commercial: Pelican COVID-19 Ultra-Rapid Mobile Test | Device ID: 2283 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Canary Global Inc. | Commercial: SARS-CoV-2 Ultra Rapid Mobile Antigen Test | Device ID: 2547 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Canary Health Technologies | Commercial: AiroStotleCV19 (Breath VOCs) | Device ID: 112 | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: CanaryQ | Commercial: Collection tools and blood separation for serology diagnostics for SARS-CoV-2 | Device ID: 817 | Method: Other | Target: Other | Format: Other | 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: CapitalBio Technology | Commercial: Respiratory Virus Nucleic Acid Detection Kit (Isothermal Amplification Chip Method) | Device ID: 114 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: CapitalBio Technology | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Integrated Isothermal Amplification Chip Method) | Device ID: 2619 | Method: LAMP | Target: Nucleic acid | Format: Automated, Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CAS-Envision | Commercial: SARS-CoV-2 Neutralizing Antibodies Test Kit | Device ID: 2788 | Method: Immunochromatography | Target: Antibody | Format: Manual | 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: Caspr Biotech | Commercial: Ultrasensitive, rapid, and portable coronavirus SARS-CoV-2 sequence detection | Device ID: 647 | Method: Other | 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