| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd | Commercial: LAMP kit for qualitative detection of SARS-CoV-2 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Institute of Chemical Biology and Fundamental Medicine | Commercial: LAMP kit for qualitative detection of SARS-CoV-2 | Method: LAMP | Target: Nucleic acid | Format: Manual | 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: No | Manufacturer: Leadgene Biomedical, Inc | Commercial: Leadgene SARS/SARS-CoV-2 Antigen Rapid Test Kit | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Leadgene Biomedical, Inc | Commercial: Leadgene SARS/SARS-CoV-2 IgG/IgM Rapid Test Kit | Method: Immunoassay | Target: Antibody | 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: 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: No | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: LightMix Modular SARS-CoV-2 (COVID19) E-gene | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: LightMix Modular SARS-CoV-2 (COVID19) N-gene | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: LightMix Modular SARS-CoV-2 (COVID19) RdRP-gene | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: No | Manufacturer: iNtRON Biotechnology Inc | Commercial: LiliF COVID-19 Real-time RT-PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: 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: Laipac Technology Inc. | Commercial: LooK SPOT | 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: No | Manufacturer: Lucira Health | Commercial: Lucira COVID-19 All-In-One Test Kit | Method: LAMP | Target: Nucleic acid | 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: No | Manufacturer: SignalDT Biotechnologies (SZ), Inc | Commercial: LyoDx A Freeze-Dried Real-Time RT-PCR Detection Reagent for SARS-CoV-2 | Method: RT-PCR | Target: Other | Format: Manual | 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: No | Manufacturer: ADT Biotech | Commercial: LyteStar 2019-nCoV RT-PCR Kit 1.0 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: No | Manufacturer: IVDbio Inc | Commercial: Machine-Free, Fast and Accurate Nucleic Acid Diagnoses System for COVID-19 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Diazyme Laboratories | Commercial: Macurra SARS-CoV-2 PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: 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 SARS-CoV-2 S-RBD IgG (CLIA) | Method: CLIA | Target: Antibody, IgG | 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: AgenaBioscience,Inc | Commercial: MassARRAY SARS-CoV-2 Panel | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: No | Manufacturer: Genalyte | Commercial: Maverick SARS-CoV-2 Multi-Antigen Serology Panel | Method: Immunoassay | Target: Antigen | Format: Lab-based | 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 |
| CE Marking: Yes | Manufacturer: MEDsan GmbH | Commercial: MEDsan COVID-19 IgM/IgG Rapid Test Hybrid | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEDsan GmbH | Commercial: MEDsan SARS-CoV-2 Antigen Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Meril Diagnostics Pvt Ltd | Commercial: Meril COVID-19 One-step RT-PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MEXACARE GmbH | Commercial: MEXACARE COVID-19 Antigen Rapid Test | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: Microblot-Array COVID-19 IgA | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: Microblot-Array COVID-19 IgG | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: Microblot-Array COVID-19 IgM | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Lumex Instruments | Commercial: Microchip RT-PCR COVID-19 detection system | Method: RT-PCR | Target: Nucleic acid | Format: 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