| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Xiamen Wiz Biotech Co. Ltd | Commercial: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-COV-2 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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: Zhuhai Livzon Diagnostics Inc | Commercial: Diagnostic Kit for Nucleic Acid to nCoV-2019 (PCR- Fluorescence Probe) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co., Ltd | Commercial: Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Solgent Co., Ltd | Commercial: DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: DIAQUICK COVID-19 Ag Cassette | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: Diaquick Covid-19 IgG/IgM | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: DIAQUICK COVID-19 IgG/IgM Cassette Rapid Test | Method: Immunoassay | Target: Antibody, IgG, IgM | 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: Diazyme Laboratories | Commercial: Diazyme DZ-LITE SARS-CoV-2 IgM CLIA kit | Method: Immunoassay | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Redcell Biyoteknoloji A.Ş | Commercial: Direct RT-qPCR SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Coyote Bioscience Co., Ltd. | Commercial: DirectDetect SARS-CoV-2 Detection Kit (PCR-Fluorescence Probe) | Method: RT-PCR | Target: | Format: Manual | 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: No | Manufacturer: OPTOLANE Technologies Inc | Commercial: Dr. PCR COVID-19 Viral Load 20K | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: PaxGen Bio Co. Ltd | Commercial: Dr. PCR COVID-19 Viral Load 20K | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Promoitalia Group SpA | Commercial: DROP-TECH | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd | Commercial: Dynamiker SARS-CoV-2 Ag Rapid Test | Method: Immunoassay | Target: Antigen | 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: Yes | Manufacturer: DyonMed SA | Commercial: DyonCovidAg | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Diatech Pharmacogenetics | Commercial: Easy SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Sys2diag | Commercial: EasyCOV | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd | Commercial: EasyNAT Integrated, Automated Molecular Diagnostic Assay for COVID-19 RNA | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Genetic Signatures Limited | Commercial: EasyScreen Pan-Coronavirus/SARS-CoV-2 Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Eurobio Scientific | Commercial: EBS1020, EBS SARS-CoV-2 Ag Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Epitope Diagnostics, Inc | Commercial: EDI Novel Coronavirus COVID-19 IgG ELISA Kit | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Epitope Diagnostics, Inc | Commercial: EDI Novel Coronavirus COVID-19 IgM ELISA Kit | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | 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: No | Manufacturer: Edinburgh Genetics Limited | Commercial: Edinburgh Genetics Virus Swab Sampling Kit | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: SensingSelf, Pte, Ltd, Singapore | Commercial: EDR COVID 19 Rapid Test Kit (IgM/IgG) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: AnyGenes | Commercial: Efficient 2019-nCOV detection kit, one step RT-qPCR (N1 & N2) | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: EIA COVID-19 NP IgA | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: EIA COVID-19 NP IgG | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | 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 IgA | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: EIA COVID-19 RBD IgG | Method: Immunoassay | Target: Antibody, IgG | 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: Yes | Manufacturer: Thermo Fisher Scientific | Commercial: EliA SARS-CoV-2-Sp1 IgG test | Method: Immunoassay | Target: Antibody, IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Elisabeth Pharmacon spol. s.r.o. | Commercial: EliGene COVID19 BASIC A RT | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Elisabeth Pharmacon spol. s.r.o. | Commercial: EliGene COVID19 BASIC A500 RT | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Elisabeth Pharmacon spol. s.r.o. | Commercial: EliGene COVID19 CONFIRM RT | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Creative Diagnostics | Commercial: ELISA: Anti-SARS-CoV-2 antibodies & NP antigen | Method: ELISA | Target: Antigen | 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: Ender diagnostics ag | Commercial: ender LAB | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ender diagnostics ag | Commercial: ender MASS | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: ENZY-WELL SARS-CoV-2 IgA | Method: Immunoassay | Target: Antibody, IgA | 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