| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Diagnostic Automation/Cortez Diagnostics, Inc | Commercial: Accudiag SCoV-2 IgG ELISA | Device ID: 1307 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diagnostic Automation/Cortez Diagnostics, Inc | Commercial: Accudiag SCoV-2 IgM ELISA Kit | Device ID: 1193 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: BIONEER Corporation | Commercial: AccuPower COVID-19 Real-Time RT-PCR kit (lab-based automated kit: NCV-1111) | Device ID: 527 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BIONEER Corporation | Commercial: AccuPower SARS-CoV-2 Real-Time RT-PCR kit (manual kit: SCV-2122) | Device ID: 528 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genomictree, Inc | Commercial: AccuraTect RT-qPCR SARS-CoV-2 | Device ID: 187 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Accuster Technologies Pvt Ltd | Commercial: Accuster SARS-COV2-RT-PCR test kit | Device ID: 763 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: ACON SARS-CoV-2 IgG/IgM Rapid Test | Device ID: 1675 | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | 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: Actim Oy | Commercial: Actim SARS-CoV-2 | Device ID: 2245 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: ActivXpress+ COVID-19 Antigen Complete Testing Kit | Device ID: 1243 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Therma Bright Inc | Commercial: AcuVid COVID-19 Rapid Antigen Saliva Test | Device ID: 2110 | Method: Immunoassay | Target: Antigen | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Addbio Meditek Co. | Commercial: AddMedi SARS-CoV-2 RT-qPCR Kit | Device ID: 2020 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: GeneMe | Commercial: Advanced One Step FAST Covi19 KIT Two Genes Set | Device ID: 177 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: ADVIA Centaur CP SARS-CoV-2 IgG (sCOVG) | Device ID: 2022 | Method: Immunoassay | Target: Antibody, IgG | Format: Lab-based, Other | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: ADVIA Centaur XP/XPT SARS-CoV-2 Antigen (CoV2Ag) | Device ID: 2016 | Method: Immunoassay | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: ADVIA Centaur XP/XPT SARS-CoV-2 IgG (sCOVG) | Device ID: 2024 | Method: Immunoassay | Target: IgG | Format: Lab-based, Other | Go to details |
| CE Marking: Yes | Manufacturer: AESKU.DIAGNOSTICS GmbH & Co. KG | Commercial: AESKU.RAPID SARS-CoV-2 | Device ID: 2108 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Aesku.Diagnostics | Commercial: AESKULISA SARS-CoV-2 NP IgA | Device ID: 1091 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Aesku.Diagnostics | Commercial: AESKULISA SARS-CoV-2 NP IgG | Device ID: 1092 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Aesku.Diagnostics | Commercial: AESKULISA SARS-CoV-2 NP IgM | Device ID: 1093 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Avacta Life Sciences Ltd | Commercial: AffiDX SARS-CoV-2 Antigen Lateral Flow Test | Device ID: 2426 | Method: | Target: Antigen | Format: | 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: Immunochromatography | 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, 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: Immunochromatography | Target: Antigen | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Sanwa Biotech Limited | Commercial: ALiA SARS-CoV-2 Antigen FIA Test | Device ID: 2115 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Abbott Molecular Inc | Commercial: Alinity m SARS-CoV-2 AMP Kit | Device ID: 1042 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: CALTH Inc. | Commercial: AllCheck COVID19 Ag | Device ID: 1647 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Seegene, Inc | Commercial: Allplex 2019-nCoV assay | Device ID: 348 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: ARROW DIAGNOSTICS SRL IT | Commercial: Allplex SARS-CoV-2 Assay | Device ID: 1128 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, 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: Advanced Molecular Diagnostics | Commercial: AMD Human SARS-CoV-2 detection kit | Device ID: 19 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: 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: Mikrogen Diagnostik | Commercial: ampliCube Coronavirus Panel | Device ID: 282 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mikrogen Diagnostik | Commercial: ampliCube Coronavirus SARS-CoV-2 | Device ID: 281 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mobidiag | Commercial: Amplidiag COVID-19 | Device ID: 935 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: Shanghai Rendu Biotechnology Co., Ltd | Commercial: AmpSure 2019-nCov RNA Assay | Device ID: 362 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: 3D Biomedicine Science & Technology Co., Limited | Commercial: ANDiS FAST SARS-CoV-2 RT-qPCR Detection Kit | Device ID: 2252 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: 3D Biomedicine Science & Technology Co., Limited | Commercial: ANDiS Viral RNA Auto Extraction & Purification Kit | Device ID: 2253 | Method: | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co., Ltd | Commercial: AndLucky COVID-19 Antigen Rapid Test | Device ID: 1296 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co., Ltd | Commercial: AndLucky SARS-CoV-2 Antigen Anterior Nasal Rapid Test (minimal invasive) | Device ID: 1842 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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