| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Creative Diagnostics | Commercial: SARS-CoV-2 IgG ELISA Kit | Device ID: 138 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Creative Diagnostics | Commercial: SARS-CoV-2 IgM ELISA Kit | Device ID: 139 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Creative Diagnostics | Commercial: SARS-CoV-2 Antigen ELISA Kit | Device ID: 140 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Credo Diagnostics Biomedical | Commercial: VitaPCR COVID-19 assay | Device ID: 141 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: CTK Biotech, Inc | Commercial: Aridia COVID-19 Real Time PCR Test | Device ID: 143 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: DAAN Gene Co., Ltd of Sun Yat-sen University | Commercial: Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR kit | Device ID: 144 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: DART Diagnostics | Commercial: DART COVID-19 | Device ID: 145 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Diagnostic Solutions Laboratory | Commercial: COVID-19 Assay | Device ID: 146 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Diagnostics for the Real World Ltd | Commercial: SAMBA II COVID-19 Test (near-POC NAT) | Device ID: 147 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Diatheva SRL | Commercial: COVID-19 PCR DIATHEVA Detection kit | Device ID: 148 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd | Commercial: Novel Coronavirus(2019-nCov)RT-PCR Kit | Device ID: 151 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd | Commercial: 2019 nCOV IgG/IgM Rapid Test | Device ID: 152 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Eagle Biosciences Inc | Commercial: COVID-19 IgM ELISA Assay | Device ID: 153 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Eagle Biosciences Inc | Commercial: COVID-19 IgG ELISA Assay | Device ID: 154 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: COVID-19 Real-time PCR Testing Kit | Device ID: 155 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: 2019 nCoV novel coronavirus antibody detection reagent (Colloidal gold) | Device ID: 156 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Epitope Diagnostics, Inc | Commercial: EDI Novel Coronavirus COVID-19 IgG ELISA Kit | Device ID: 157 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Epitope Diagnostics, Inc | Commercial: EDI Novel Coronavirus COVID-19 IgM ELISA Kit | Device ID: 158 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: EURORealTime SARS-CoV-2 | Device ID: 159 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: Anti-SARS-CoV-2 ELISA (IgA) | Device ID: 160 | Method: ELISA | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Fast Track Diagnostics | Commercial: FTD-114 SARS-CoV-2 (manual & lab-based NAT) | Device ID: 163 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: FemtoDx | Commercial: COVID-19 Antibody Test | Device ID: 164 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: FemtoDx | Commercial: COVID-19 Rapid Home Nucleic Acid Test | Device ID: 165 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Fulgent Genetics/MedScan Laboratory | Commercial: COVID-19 | Device ID: 166 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Fluxergy LLC | Commercial: Fluxergy Sample-to-Answer SARS-CoV-2 RT-PCR | Device ID: 167 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: GenBody, Inc | Commercial: GenBody COVID-19 IgM/IgG | Device ID: 169 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: GenBody, Inc | Commercial: GenBody FIA COVID-19 IgM/IgG | Device ID: 170 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Gencurix Inc | Commercial: GenePro COVID-19 Detection Test | Device ID: 171 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Gencurix Inc | Commercial: GenePro SARS-CoV-2 Test | Device ID: 172 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Gene Biosystems | Commercial: Gene Bio COVID-19 Qualitative Real Time PCR Kit Ver. 1.0 | Device ID: 173 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Genedrive plc | Commercial: Genedrive 96 SARS-CoV-2 Kit | Device ID: 174 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based | Go to details |
| CE Marking: No | Manufacturer: GeneFirst Ltd | Commercial: Respiratory Pathogen Panel | Device ID: 176 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: No | Manufacturer: geneOmbio Technologies Pvt. Ltd | Commercial: geneOmbio COVID-19 rt-LAMP test | Device ID: 178 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: General Biologicals Corporation | Commercial: GB SARS-CoV-2 Real Time RT-PCR | Device ID: 179 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: GeneReach Biotechnology Corporation | Commercial: POCKIT Central SARS-CoV-2 (orf 1ab) Premix Reagent | Device ID: 180 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: No | Manufacturer: Genesystem, Co. Ltd | Commercial: SMARTCHECK SARS-CoV2 Detection Kit | Device ID: 181 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Genetic Signatures Limited | Commercial: EasyScreen Pan-Coronavirus/SARS-CoV-2 Detection Kit | Device ID: 182 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: GenMark Diagnostics | Commercial: ePlex SARS-CoV-2 Test | Device ID: 184 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Genomica Sau | Commercial: qCOVID-19 | Device ID: 185 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genomica Sau | Commercial: CLART COVID-19 | Device ID: 186 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, 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: No | Manufacturer: GenScript | Commercial: 2019-nCoV qRT-PCR Detection Assay | Device ID: 188 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech, Inc | Commercial: Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit | Device ID: 189 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech, Inc | Commercial: One Step Test for Novel Coronavirus(2019-nCoV) IgM/IgG antibody (Colloidal Gold) | Device ID: 190 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: GNA Biosolutions GmbH | Commercial: Sars-CoV-2 Detection Kit on portable PCA Analyzer | Device ID: 191 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Goldsite Diagnostics Inc | Commercial: SARS-CoV-2 IgG/IgM Kit (manual) | Device ID: 192 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Vela Diagnostics | Commercial: SARS-CoV-2 Direct Test | Device ID: 193 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangdong Huayin Medicine Science Co.,. Ltd | Commercial: Detection Kit for 2019-nCoV RNA (RT-PCR Fluorescence Probing) (Lyophilised) | Device ID: 194 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Darui Biotechnology Co.,Ltd | Commercial: 2019 Novel Coronavirus (2019-nCoV) IgM Antibody Detection Kit (ELISA Method) | Device ID: 195 | Method: ELISA | Target: Antibody | 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