| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| 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: 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: 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/Flu Ag Combo Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: 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, viral Antigen | Method: Immunoassay | Target: Antigen | Format: 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: 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: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: iFlash-2019-nCoV Antigen | Method: Immunoassay | Target: Antigen | 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 NAb | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | 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: 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: 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: Eurofins_Ingenasa | Commercial: INGEZIM Covid 19 CROM | Method: Immunoassay | Target: Antibody | 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: 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: Confirm Bioscience | Commercial: Instant COVID-19 “Coronavirus” 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: 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: 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: 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: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 Antigen Rapid Test Kit (FIA) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 IgG/IgM antibody Rapid Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 total antibody rapid test | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Quark Biotechnology Co., Ltd | Commercial: Kwork Covid-19 Ag Rapid Test Device(Saliva/Sputum/Feces) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BMT Diagnostics | Commercial: Lab-On-Time 2019-nCoV IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BMT Diagnostics | Commercial: Lab-On-Time COVID-19 Antigen Rapid Test Device (Integrated Throat Swab) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DiaSorin S.p.A | Commercial: LIAISON SARS-CoV-2 S1/S2 IgG | Method: Immunoassay | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: DIASORIN S.P.A. | Commercial: LIAISON® SARS-CoV-2 TrimericS IgG (Ref.311510) | Method: Immunoassay | Target: IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Liangrun Biomedicine Technology Co., Ltd. | Commercial: LionRun™️SARS-CoV-2 Antigen Rapid Test Kit (Lateral Flow Immunoassay) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Livzon Diagnostics Inc | Commercial: Livzon Rapid Test for SARS-CoV-2 Antigen (Lateral Flow) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Livzon Diagnostics Inc | Commercial: Livzon Test for SARS-CoV-2 Antigen (Fluorescence Immunochromatographic Assay) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Laipac Technology Inc. | Commercial: LooK SPOT | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: LumiraDX UK Ltd | Commercial: LumiraDx SARS-CoV-2 Ag Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Laihe Biotech Co., Ltd | Commercial: LYHER Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Laihe Biotech Co., Ltd | Commercial: LYHER Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co., Ltd | Commercial: Maccura SARS-CoV-2 IgG | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co., Ltd | Commercial: Maccura SARS-CoV-2 IgM | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co., Ltd | Commercial: MAGLUMI 2019-nCoV IgG (CLIA) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co., Ltd | Commercial: MAGLUMI 2019-nCoV IgM (CLIA) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: ArcDia International Ltd | Commercial: mariPOC SARS-CoV-2 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BBB INC; Obelis S.A.(BE) | Commercial: MARK-B COVID-19 Ag S | Method: Immunoassay | Target: Antigen | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: InTelos, Inc. | Commercial: MAUVE COVID-19 Ag Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Medikit | Commercial: MediKit Covid-19 Antibody Test (IgM/IgG Lateral flow Immunoassay) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Nano Diagnosis of Health Biotechnology Co., Limited | Commercial: Mednano | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MPC International S.A. | Commercial: MEDsan COVID-19 IgM/IgG 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