| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Wondfo | Commercial: COVID-19 Rapid Test, WONDFO SARS-CoV-2 Antibody Test (Lateral Flow Method) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Willi Fox GmbH | Commercial: COVID-19 Test IgM/ IgG | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vazyme | Commercial: COVID-19/Influenza A virus/Influenza B virus test kit (Rare Earth Nano Fluorescence Immunochromatography) | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: JOYSBIO (Tianjin) Biotechnology Co., Ltd | Commercial: COVID-9 IgG/IgM Rapid Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Pharmatech | Commercial: COVID19 IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Novus Biologicals LLC, Bio-techne brand | Commercial: COVID19 IgG/IgM Rapid Test Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd | Commercial: COVIDscreen Plus ELISA Kit | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd | Commercial: CoviDx | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zephyr Biomedicals-Tulip Group | Commercial: COVISCREEN test for detection of IgM/IgG/IgA antibodies | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Oncosem Onkolojik Sistemler San. ve Tic. A.S. | Commercial: CRT (COVID 19 RAPID TEST) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Lionrun | Commercial: Diagnostic kit for antibody IgM/IgG of Novel Coronavirus COVID-19 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Livzon Diagnostics Inc | Commercial: Diagnostic Kit for IgM / IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Diazyme Laboratories | Commercial: Diazyme DZ-LITE SARS-CoV-2 IgG | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Chembio Diagnostic Systems | Commercial: DPP COVID-19 IgM/IgG System | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Alfa Scientific Designs Inc | Commercial: DrivenFlow COVID-19 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: DyonCovid19 - SARS-CoV-2 IgM/IgG Antibody Rapid Test Device. | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Edinburgh Genetics Limited | Commercial: Edinburgh Genetics Complete Whole Blood Collection Kit | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: Edinburgh Genetics COVID-19 Colloidal Gold Immunoassay Testing Kit, IgG/IgM Combined | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: EIA COVID-19 NP IgM | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: EIA COVID-19 RBD IgM | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: ROCHE Diagnostics | Commercial: Elecsys Anti-SARS-CoV-2 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Bio-Techne | Commercial: Ella / Simple Plex COVID-19 16×4 Standard Panel | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Pardee lab | Commercial: En Carta SARS-CoV-2 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: ENZY-WELL SARS-CoV-2 IgG | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: ENZY-WELL SARS-CoV-2 IgM | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DxGen Corp. | Commercial: Epithod®616 IgG Test Kit | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Erba Corporate Services | Commercial: ErbaLisa COVID-19 IgM ELISA | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Prantae Solutions Pte Ltd | Commercial: EyeRa-Covid | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Superbio Biomedical Technology (Nanjing) Co., Ltd | Commercial: Fast SARS-CoV-2 lgM/lgG Antibody Detection Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co., Ltd | Commercial: Finecare SARS-CoV-2 Antibody Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co., Ltd | Commercial: Finecare SARS-CoV-2 IgG Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co., Ltd | Commercial: Finecare SARS-CoV-2 IgM/IgG Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Shanghai Fosun Long March Medical Science Co.,Ltd | Commercial: Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NanoEntek | Commercial: FREND COVID-19 IgG/IgM Duo | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: NanoEntek | Commercial: FREND COVID-19 SP | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: NanoEntek | Commercial: FREND COVID-19 total Ab | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: General Biologicals Corporation | Commercial: GB SARS-CoV-2 Ab ELISA | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GenBody, Inc | Commercial: GenBody FIA COVID-19 IgM/IgG | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Green Cross Medical Science Corp. | Commercial: GENEDIA W ONE COVID 19 IgM&IgG | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Genonto RapidTest10 COVID-19 IgG/IgM Antibody Rapid Test Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc | Commercial: GenSure COVID-19 IgG/IgM Rapid Test (REF: P2002) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc | Commercial: GenSure COVID-19 IgM Rapid Test (REF: P2001) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: GenSure COVID-19 Neutralizing Antibody Test (Fluorescence) | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: GLINE-2019-nCoV NAb | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Vela Diagnostics | Commercial: Great Basin System SARS-CoV-2 Direct Test | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co., Ltd | Commercial: Hightop SARS-CoV-2 IgM/IgG Antibody Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Predigen Inc | Commercial: HR-PreV | 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 |
| 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: 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 |
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