| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Neo Nostics (Suzhou) Bioingeneering Co. LTD | Commercial: 2019-nCoV(COVID-19) IgG&IgM Rapid Test Kit | Device ID: 1022 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd | Commercial: nCoV IgG/IgM combo test | Device ID: 1023 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Technogenetics SRL | Commercial: RAPID TEST SARS-CoV-2 IgM/IgG GOLD | Device ID: 1024 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Tregena | Commercial: 3gamma COVID-19 IgA / IgM / IgG | Device ID: 1026 | Method: Immunoassay | Target: Antibody, IgG, IgM, IgA | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Well Biotech | Commercial: COVID-19 IgM/IgG Rapid Test (Colloidal Gold) | Device ID: 1027 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Newbury Pharmaceuticals S.A | Commercial: COVID-19 Coronavirus Rapid Test Kit | Device ID: 1029 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Tersaco AG | Commercial: SARS CoV-2 IgG/IgM Rapid Test | Device ID: 1030 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zenum Technologies | Commercial: COVID-19 IgG/IgM Rapid Test | Device ID: 1031 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Abbott | Commercial: BasePoint Covid-19 IgG/IgM Rapid test Device | Device ID: 1032 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co., Ltd | Commercial: Maccura SARS-CoV-2 IgM | Device ID: 1033 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co., Ltd | Commercial: Maccura SARS-CoV-2 IgG | Device ID: 1034 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Safecare Biotech (Hangzhou) Co. Ltd | Commercial: COVID-19 IgG/IgM Rapid Test Device (Whole Blood/Plasma/Serum) | Device ID: 1035 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Lab-based, Near POC / POC | 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: Epigentek Group Inc | Commercial: SeroFlash SARS-CoV-2 IgM/IgG Antibody Detection Kit | Device ID: 1038 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Salofa Oy | Commercial: Sienna COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 1039 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Abbott Molecular Inc | Commercial: Abbott RealTime SARS-CoV-2 | Device ID: 1041 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: Jiangsu Dabo Pharmaceutical Co., Ltd | Commercial: Rapid test for IgM/IgG Antibody to SARS-CoV-2 | Device ID: 1043 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Epigentek Group Inc | Commercial: SeroFlash SARS-CoV-2 IgG/IgM ELISA Fast Kit | Device ID: 1044 | Method: ELISA | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Sys2diag | Commercial: EasyCOV | Device ID: 1045 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: General Biologicals Corporation | Commercial: GB SARS-CoV-2 Real-Time RT-PCR(E gene/ORF1ab) | Device ID: 1046 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Salofa Oy | Commercial: Salocor COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 1047 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: 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: Siemens Healthineers | Commercial: SARS-CoV-2 Total (COV2T) assay | Device ID: 1049 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: SARS-CoV-2 Total Ab | Device ID: 1050 | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MPC International S.A. | Commercial: MEDsan COVID-19 IgM/IgG Rapid Test | Device ID: 1051 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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 |
| CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: SARS-CoV-2 IgG | Device ID: 1053 | Method: Immunoassay | Target: Antibody, IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: SARS-CoV-2 IgM | Device ID: 1054 | Method: Immunoassay | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: Diaquick Covid-19 IgG/IgM | Device ID: 1055 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TeraBioSafety Ltd | Commercial: Coronavirus Breath Analyzer | Device ID: 1056 | Method: Other | Target: Other | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangdong Longsee Biomedical Co., Ltd | Commercial: 2019-nCoV Nucleic Acid Detection Kit (Q-PCR Method) | Device ID: 1057 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Xfold Imaging | Commercial: Xfold immunoassay | Device ID: 1058 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genmark Saglik Urunleri | Commercial: geneMAP 2019-nCoV (SARS-CoV-2) Rapid Detection Kit | Device ID: 1059 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: GeneProof a.s. | Commercial: GeneProof SARS-CoV-2 PCR Kit | Device ID: 1061 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: GeneProof a.s. | Commercial: GeneProof SARS-CoV-2 Screening PCR Kit | Device ID: 1062 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Megna Health Inc | Commercial: Rapid COVID-19 IgM/IgG Combo Test Kit (Antibody) | Device ID: 1063 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Becton Dickinson | Commercial: BD Veritor™ System for Rapid Detection of SARS CoV 2 | Device ID: 1065 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Eternal Materials Co., Ltd | Commercial: COVIDual COVID-19 IgM/IgG Rapid Test | Device ID: 1066 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEDsan GmbH | Commercial: MEDsan COVID-19 IgM/IgG Rapid Test Hybrid | Device ID: 1068 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VEDALAB | Commercial: COVID-19-CHECK-1 test | Device ID: 1069 | Method: Chromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics | Commercial: 2019-nCoV IgG/IgM Rapid Test | Device ID: 1070 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2 IgG (CLIA) | Device ID: 1071 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2 IgM (CLIA) | Device ID: 1072 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC | Commercial: Test Rapid IgG/IgM 2019-nCoV | Device ID: 1073 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CORMAY | Commercial: Cormay Rapid SARS-CoV-2 IgG/IgM Ab | Device ID: 1074 | Method: Chromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics | Commercial: COVID-19 Lyophilised Nucleic Acid Kit | Device ID: 1075 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd | Commercial: SARS-CoV-2 IgG assay | Device ID: 1076 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MultiplexDX | Commercial: vDetect COVID-19 RT-qPCR diagnostic kit | Device ID: 1077 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, 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