| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Kephera Diagnostics | Commercial: KDx COVID-19 Antigen Detection Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: OPTOLANE Technologies Inc | Commercial: Kaira 2019-nCoV Detection kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Jinwofu Bioengineering Technology Co.,Ltd | Commercial: Jinwofu® Novel Coronavirus (SARS-CoV-2) Antigen-Rapid-Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: NanoBio Lab, A*STAR Research Entities | Commercial: Isothermal Exponential Amplification for COVID-19 Detection | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: M monitor Inc | Commercial: Isopollo COVID-19 detection Kit (real-time) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PlexBio Co., Ltd | Commercial: IntelliPlex SARS-CoV-2 Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Alfa Scientific Designs, Inc. | Commercial: Instant-view® PLUS COVID-19 Antigen Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Alfa Scientific Designs Inc | Commercial: Instant-view PLUS COVID-19 Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biyoteknoloji Ltd. Şti. | Commercial: Instant SARS-CoV-2 Rapid Ag Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Confirm Bioscience | Commercial: Instant COVID-19 “Coronavirus” Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: B-bio Co., Ltd. | Commercial: INNOGEN-B™ COVID-19 IgM/IgG Rapid test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins_Ingenasa | Commercial: INGEZIM Covid 19 DR | Method: Immunoassay | Target: Antibody, IgA | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins_Ingenasa | Commercial: INGEZIM Covid 19 CROM | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: INFO SARS-CoV-2 IgM/IgG Ab Test | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hoyotek Biomedical Co.,Ltd | Commercial: Influenza A/B/Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nantong Diagnos Biotechnology | Commercial: Influenza A+B Antigen Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mabsky Bio-Tech Co., Ltd | Commercial: Influenza A virus, Influenza B virus & COVID-19 virus (2019-nCoV) Triple-Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Beijing Infervision Technology Co. Ltd | Commercial: InferRead CT Pneumonia | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: InBios International | Commercial: InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SACEM Hayat Teknolojileri A.S. | Commercial: iNADx Multiplex III COVID-19 RT-qPCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co., Ltd. | Commercial: Immunobio SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non invasive) | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Immuno Biotech Co.,Ltd | Commercial: Immunobio SARS-CoV-2 Antigen ANTERIOR NASAL Rapid Test Kit (minimal invasive) | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Metas Biomedical Inc. | Commercial: ImmTek COVID-19 Antigen Rapid Test | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Instituto de Medicina Genómica | Commercial: Imegen SARS-CoV-2 plus | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Instituto de Medicina Genómica | Commercial: Imegen SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Zhengzhou Fortuna Bioscience | Commercial: IgG/IgM Antibody Rapid Test Kits (Colloidal Gold Immunochromatography method) | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: iFlash-SARS-CoV-2 IgM | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: iFlash-SARS-CoV-2 IgG | Method: | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: iFlash-2019-nCoV NAb | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: iFlash-2019-nCoV IgA | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: iFlash-2019-nCoV Antigen | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Immundiagnostik AG | Commercial: IDK® anti-SARS-CoV-2 IgG ELISA | Method: ELISA | Target: IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Innovative Diagnostics | Commercial: ID Screen® SARS-CoV-2-N IgG Indirect | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Innovative Diagnostics | Commercial: ID Screen® SARS-CoV-2 Double Antigen Multi-species | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: ID.vet | Commercial: ID Screen SARS-CoV-2-N IgG Indirect ELISA Kit (manual, automated) | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Innovative Diagnostics | Commercial: iD Rapid® COVID-19 Antigen | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: Ichroma COVID-19, viral Antigen | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: Ichroma COVID-19 Ab, IgM/IgG | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: ichroma COVID-19/Flu Ag Combo | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Humasis | Commercial: Humasis COVID-19/Flu Ag Combo Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Humasis | Commercial: Humasis COVID-19 IgG/IgM Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Humasis | Commercial: Humasis COVID-19 Ag Test | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human SARS-CoV-2 (Covid-19) Qualitative ELISA (manual) | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Quansys Biosciences | Commercial: Human COVID-19 (2-plex) | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Human anti-SARS-CoV-2 IgM ELISA | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Human anti-SARS-CoV-2 IgG ELISA Kit | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) Spike Protein IgG ELISA (manual) | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) Nucleocapsid Protein IgG ELISA (manual) | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) IgM Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody | 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