| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co., Ltd | Commercial: COVID-19 Antigen Rapid Test (Latex) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co., Ltd | Commercial: COVID-19 Rapid Antigen Test (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co., Ltd | Commercial: SARS-CoV-2 IgM/IgG Antibody Test (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co., Ltd | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test (Colloidal Gold) | Method: Immunoassay | Target: IgG | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co., Ltd | Commercial: SARS-COV-2/Influenza A&B Rapid Antigen Test | Method: Immunochromatography | Target: Antigen | Format: Manual | 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: Yes | Manufacturer: JOYSBIO (Tianjin) Biotechnology Co., Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: JOYSBIO (Tianjin) Biotechnology Co., Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit - Saliva (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Kephera Diagnostics | Commercial: KDx COVID-19 Antigen Detection Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Kephera Diagnostics | Commercial: KDx COVID-19 IgG and IgM ELISA (manual) | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Kephera Diagnostics | Commercial: KDx COVID-19 IgG/IgM Rapid Detection Test Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: KH Medical Co. Ltd | Commercial: RADI COVID-19 Detection Kit and RADI COVID-19 Triple Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: KitL&H Biotech Limited | Commercial: COVID-19 Antigen Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Kogene Biotech | Commercial: 2019 Novel Coronavirus Real-time PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Kogene Biotech | Commercial: PowerChek 2019-nCoV Real-time PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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 |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) Spike Protein IgG ELISA (manual) | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human SARS-CoV-2 (Covid-19) Qualitative ELISA (manual) | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: KRISHGEN BioSystems | Commercial: SARS-CoV-2 (Covid-19) Real-Time PCR Kit (as per CDC Atlanta guidelines) | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: No | Manufacturer: Kurabo Industries Ltd | Commercial: SARS-CoV-2 Antibody IgM/IgG Testing Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Labnovation Technologies Inc | Commercial: COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Labnovation Technologies Inc | Commercial: SARS-CoV-2 Antigen Rapid Test Kit | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Laboratory Corporation of America | Commercial: LabCorp 2019 Novel Coronavirus test | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Labtest Diagnostica | Commercial: ANTI COVID-19 IGG/IGM RAPID TEST | Method: Immunoassay | Target: Antibody | 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: No | Manufacturer: Landcent Europe B.V. | Commercial: Real time RT-PCR Kit for the detection of SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Lansion Biotechnology Co., Ltd. | Commercial: (COVID-19) IgM/IgG Test Kit (Dry Fluorescence Immunoassay) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Lansion Biotechnology Co., Ltd. | Commercial: COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay) | Method: Immunoassay | Target: Antigen | Format: 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: No | Manufacturer: Lifeassay Diagnostics Pty Ltd | Commercial: Test-it COVID-19 IgM/IgG Lateral Flow Assay | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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: Lifotronic Technology Co, Ltd | Commercial: Antigen Rapid Test Ag SARS-CoV-2 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Liming Bio | Commercial: Rapid Test Antigen SARS- CoV-2 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Liming Bio-Products Co., Ltd | Commercial: COVID-19 Antigen Rapid Test Device | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Liming Bio-Products Co., Ltd | Commercial: COVID-19 IgG/IgM Combo Rapid Test Device | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Liming Bio-Products Co., Ltd | Commercial: SrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: LINEAR CHEMICALS, S.L.U. | Commercial: Cromatest COVID-19 Antigen Cassette | Method: Immunochromatography | Target: Antigen | 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: LOMINA AG | Commercial: COVID-19 Antigen Rapid Test Device; SARS-CoV-2 (N)protein Antigen rapid test (Fluorescence Immunochromatics assay) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: LOMINA AG | Commercial: SARS-CoV-2(COVID19)IgM/IgG Antibody Fast Detection Kit | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | 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: No | Manufacturer: Lumex Instruments | Commercial: Microchip RT-PCR COVID-19 detection system | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Luminex Corp. | Commercial: ARIES SARS-CoV-2 Assay | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Luminex Corp. | Commercial: NxTAG CoV Extended Panel | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Luminostics, Inc | Commercial: CLIP-COVID19 (smartphone-read out high sensivity antigen detection test) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: LumiQuick Diagnostics Inc | Commercial: QuickProfile 2019-nCoV IgG/IgM Combo Test Card | 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