| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: TestNOW® - COVID-19 IgG/IgM Test | Device ID: 2132 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: TestNOW® - COVID-19 NAb Quantitative Test | Device ID: 2134 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AgenaBioscience Inc. | Commercial: MassARRAY SARS-CoV-2 Panel | Device ID: 1396 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: AIDIAN | Commercial: Acro 2019-nCoV IgG/IgM pikatesti | Device ID: 994 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AIETech Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Detection Kit (AIE Fluorescence Immunochromatography) | Device ID: 3036 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 3022 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Immunochromatography) | Device ID: 3016 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Saliva) | Device ID: 3023 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Test Kit(Immunochromatography) | Device ID: 3017 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Test Kit(Nasal/Nasopharyngeal/Oropharyngeal/Saliva) | Device ID: 3024 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AITbiotech | Commercial: abTES COVID-19 qPCR I Kit | Device ID: 468 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: AITbiotech | Commercial: abTES™ Qd COVID‐19 qPCR I Kit | Device ID: 3131 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AITBIOTECH PTE Ltd. | Commercial: abTES COVID-19 Variant qPCR I Kit | Device ID: 3119 | Method: RT-PCR | Target: | Format: Automated, Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: AITBIOTECH PTE Ltd. | Commercial: abTES Qd Sample Preparation Kit | Device ID: 3130 | Method: RT-PCR | Target: Other | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AITBIOTECH PTE Ltd. | Commercial: abTES™ Flu/COVID-19 qPCR I Kit | Device ID: 3129 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Semi-automated | 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: Yes | Manufacturer: Akralab | Commercial: 2019nCoV IgG/IgM Rapid test Device | Device ID: 1002 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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: Yes | Manufacturer: Alfa Scientific Designs Inc. | Commercial: DrivenFlow COVID-19 | Device ID: 21 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Alfa Scientific Designs Inc. | Commercial: Instant-view PLUS COVID-19 Test | Device ID: 958 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Alfa Scientific Designs Inc. | Commercial: Instant-view® PLUS COVID-19 Antigen Test | Device ID: 1678 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: ALIMETRIX Inc. | Commercial: SARS-CoV-2 (COVID-19) serological test | Device ID: 1427 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: ALLUM SRL | Commercial: DAILY TAMPON | Device ID: 1852 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AlphaBiolabs | Commercial: AlphaBiolabs IgM-IgG Combined Antibody Rapid Test | Device ID: 900 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Alphadia | Commercial: Alphadia | Device ID: 1803 | Method: Immunoassay | Target: IgG | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Alphagen Bio-Technology Co.,Ltd | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 3965 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Alphagen Bio-Technology Co.,Ltd | Commercial: SARS-CoV-2 Antigen Test Kit(Colloidal Gold) | Device ID: 3265 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Altona Diagnostics | Commercial: RealStar SARS-CoV-2 RT-PCR Kit | Device ID: 22 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Amazing Biotech (Shanghai) Co. Ltd. | Commercial: COVID-19 Antigen Sealing Tube Test Strip (Colloidal Gold) | Device ID: 2075 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Amazing Biotech (Shanghai) Co. Ltd. | Commercial: Ultrafast Twinblock 8 Wells Real Time PCR Instrument | Device ID: 4080 | Method: RT-PCR | Target: RNA | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMEDA Labordiagnostik GmbH | Commercial: AMP Rapid Test SARS-CoV-2 Ag | Device ID: 1304 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMEDA Labordiagnostik GmbH | Commercial: AMP Rapid Test SARS-CoV-2 IgG/IgM | Device ID: 993 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMEDA Labordiagnostik GmbH | Commercial: Rapid Test SARS-CoV-2 Ag | Device ID: 1602 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Amedica SA | Commercial: Amela Covid-19 Antigen test | Device ID: 829 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Amedica SA | Commercial: Amela Covid-19 IgM IgG Combo test kit | Device ID: 830 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Amedica SA | Commercial: Amela SARS CoV-2 Real time PCR Detection kit | Device ID: 831 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Amoy Diagnostics Co. Ltd. | Commercial: AmoyDx Novel Coronavirus (2019 nCoV) Detection Kit | Device ID: 29 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: AMPER COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) | Device ID: 2936 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: AMPER COVID-19 Neutralizing Antibody Rapid Testing kit (Colloidal Gold) | Device ID: 2873 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: AMPER RSV Antigen Rapid Test (Colloidal Gold) | Device ID: 2870 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: Quadruple Fast Test Pen (Latex) For SARS-CoV-2 & influenza A/B antigens and COVID-19 Neutralizing antibody | Device ID: 3579 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: RSV-SC2-Flu Quadruplex Fast Test (Colloidal Gold) For RSV SARS-CoV-2 & Influenza A/B antigens | Device ID: 5799 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: SC2Flu Triplex Fast Test (Colloidal Gold) For SARS-CoV-2 & influenza A/B antigens | Device ID: 2872 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Amplicon Ltd. | Commercial: AmpliTest SARS-CoV-2 (Real Time PCR) | Device ID: 509 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV Antigen Device | Device ID: 1203 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV Antigen Device (Anterior Nasal Swab) | Device ID: 2605 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV IgG/IgM Device | Device ID: 1048 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV Neutralising Antibody | Device ID: 2225 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: COVID-19 Antigen ELISA | Device ID: 1280 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: COVID-19 Lyophilised Nucleic Acid Kit | Device ID: 1052 | Method: RT-PCR | Target: Nucleic acid | 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