| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| 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: AgenaBioscience,Inc | Commercial: MassARRAY SARS-CoV-2 Panel | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: ArcDia International Ltd | Commercial: mariPOC SARS-CoV-2 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co., Ltd | Commercial: MAGLUMI SARS-CoV-2 S-RBD IgG (CLIA) | Method: CLIA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co., Ltd | Commercial: MAGLUMI SARS-CoV-2 Neutralizing Antibody (CLIA) | Method: CLIA | 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: Snibe Co., Ltd | Commercial: MAGLUMI 2019-nCoV IgG (CLIA) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | 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: 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: Quidel Corporation | Commercial: Lyra SARS-CoV-2 Assay | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: 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: 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: Eiken Chemical Co. Ltd | Commercial: Loopamp SARS-CoV-2 Detection kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: Co-diagnostics | Commercial: Logix Smart Coronavirus disease 2019 (COVID-19) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: 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: 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: Redcliffebio | Commercial: LightPower iVASARS-CoV-2 1st RT-rPCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Liferiver | Commercial: Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCRT kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: 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: Pharmaline AS | Commercial: LAMPIGEN COVID19 RT-LAMP PCR KIT | Method: LAMP | Target: Nucleic acid | Format: Manual, 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: 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: AniCon Labor GmbH | Commercial: Kylt SARS-CoV-2 Screening RTU RT-qPCR | Method: | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AniCon Labor GmbH | Commercial: Kylt SARS-CoV-2 Confirmation RT-Qpcr | Method: RT-PCR | Target: Nucleic acid | Format: 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: Krosgen Biotech | Commercial: KrosQuanT SARS-COV- 2 (2019 nCOV) Realtime PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: gerbion GmbH & Co., | Commercial: KG virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 total antibody ELISA Test Kit | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 RT-PCR Test Kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 IgM antibody ELISA Test Kit | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | 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 IgG antibody ELISA Test Kit | Method: ELISA | Target: Antibody | Format: Automated, Manual | 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 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 (Colloidal Gold) | 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: 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 |
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