| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Beroni Group | Commercial: SARS-CoV-2 IgG/igM Antibody Detection Kit | Device ID: 697 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BforCure | Commercial: Bfast [FluA/FluB/SARS-CoV-2] RT-PCR kit - 48 | Device ID: 5731 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BforCure | Commercial: Bfast [FluA/FluB/SARS-CoV-2] RT-PCR kit - for Chronos Dx | Device ID: 5730 | Method: RT-PCR | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BforCure | Commercial: Bfast [SARS-CoV-2] RT-PCR kit - 48 | Device ID: 5729 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BforCure | Commercial: Bfast [SARS-CoV-2] RT-PCR kit - for Chronos Dx | Device ID: 5728 | Method: RT-PCR | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: BGI | Commercial: 2019-nCoV nucleic acid detection kit using combinatorial probe-anchor synthesis method | Device ID: 83 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BGI | Commercial: Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 | Device ID: 920 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BGI Europe A/S | Commercial: SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) | Device ID: 2988 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: Yes | Manufacturer: Bio Basic Inc. | Commercial: SARS-CoV- RT-PCR Detection Kit | Device ID: 921 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BIO GROUP MEDICAL SYSTEM | Commercial: COVID-19 ANTIGEN RAPID TEST CASSETTE | Device ID: 2122 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Bio-Rad Laboratories Inc. | Commercial: Bio-Rad SARS CoV-2 ddPCR Assay | Device ID: 541 | Method: Digital-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Bio-Rad Laboratories Inc. | Commercial: Platelia SARS-CoV-2 Total Ab Assay | Device ID: 756 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Bio-Techne | Commercial: Ella / Simple Plex COVID-19 16×4 Standard Panel | Device ID: 85 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: (COVID-19) IgM/IgG Antibody Rapid Test Kit | Device ID: 2703 | Method: Chromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: (COVID-19) IgM/IgG Antibody Rapid Test Kit (Latex Chromatography) | Device ID: 2706 | Method: Immunochromatography | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit | Device ID: 3079 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) | Device ID: 2704 | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) (anterior nasal swab) | Device ID: 3081 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography) | Device ID: 2705 | Method: Chromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biobase Biodustry（Shandong） Co. Ltd. | Commercial: 2019-nCoV IgM/IgG Antibody Test Kit（Colloidal Gold） | Device ID: 2895 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biobase Biodustry（Shandong） Co. Ltd. | Commercial: 2019-Novel Coronavirus (2019-nCoV) RT-qPCR Detection Kit | Device ID: 2900 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biobase Biodustry（Shandong） Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2864 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biobase Diagnostic Technology (Shandong) Co. Ltd. | Commercial: BIOBASE COVID-19 Antigen Rapid Test (Self-testing) | Device ID: 3112 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biobase Diagnostic Technology (Shandong) Co. Ltd. | Commercial: BIOBASE COVID-19 Antigen Rapid Test（Self-Test） | Device ID: 3071 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biocan Diagnostics Inc. | Commercial: Tell Me Fast COVID19 Antigen Test | Device ID: 2673 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biocan Diagnostics Inc. | Commercial: Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Ab Test | Device ID: 524 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biocartis | Commercial: IdyllaTM SARS-COV-2 Test | Device ID: 2662 | Method: RT-PCR | Target: Nucleic acid | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: Biocartis | Commercial: IdyllaTM SARS-COV-2/FLU/RSV Panel | Device ID: 2663 | Method: RT-PCR | Target: | Format: Fully automated (robot) | Go to details |
| CE Marking: No | Manufacturer: Biocerna | Commercial: SARS-CoV-2 Test | Device ID: 708 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Biocheck GmbH | Commercial: Anti-SARS-CoV-2 IgG | Device ID: 1099 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biocomma limited | Commercial: biocomma®COVID-19 Antigen Test Kit | Device ID: 1687 | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biocomma limited | Commercial: Novel Coronavirus COVID-19 IgM/IgG Test Kit | Device ID: 1686 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioCore | Commercial: BioCore 2019-nCoV Real Time PCR Kit | Device ID: 1402 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Biodesix | Commercial: Biodesix SARS-CoV-2 Droplet Digital PCR (ddPCR ) Test | Device ID: 758 | Method: Digital-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Biodesix | Commercial: SARS-CoV-2 Droplet Digital PCR (ddPCR) test | Device ID: 709 | Method: Digital-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BioDetect (Xiamen) Biotechnology Co. Ltd. | Commercial: RAPID SARS-COV-2 ANTIGEN TEST CARD | Device ID: 3099 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioDetect (Xiamen) Biotechnology Co. Ltd. | Commercial: RAPID SARS-COV-2 ANTIGEN TEST CARD (self test) | Device ID: 2902 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioeksen R&D Technologies Ltd. | Commercial: Bio-Speedy Direct RT-qPCR SARS-CoV-2 | Device ID: 1060 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bioeksen R&D Technologies Ltd. | Commercial: Bio-Speedy SARS-CoV-2 (2019-nCoV) qPCR Detection Kit | Device ID: 525 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Biofeld Diagnostic and Lab Solutions INC. | Commercial: Biofeld Covid-19 Antigen Schnelltest | Device ID: 3504 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: BioFire Diagnostics | Commercial: BioFire COVID-19 test | Device ID: 710 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: Biogenix Inc. Pvt Ltd. | Commercial: SARS CoV-2 IgG/IgM Ab Rapid Test | Device ID: 777 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioGnost Ltd. | Commercial: CoviGnost AG Test Device 1x20 | Device ID: 2247 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BioGnost Ltd. | Commercial: CoviGnost AG test devices | Device ID: 2481 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: BioGX | Commercial: SARS-CoV-2 in the Open System Reagents for BD MAX | Device ID: 459 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: BOH-180 Fluorescent Immunoassay Analyzer | Device ID: 2694 | Method: Immunochromatography | Target: Antibody, Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Quantitative Assay Kit (Enzyme-linked Immunoassay) | Device ID: 1293 | Method: ELISA | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Quantitative Test (Fluorescence Immunochromatography)-Anterior Nasal Swab | Device ID: 2692 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | 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