| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV / SARS-CoV-2 (COVID-19) nucleocapsid antibody [6H3] (GTX632269)_ELISA | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV / SARS-CoV-2 (COVID-19) spike antibody [1A9] (GTX632604) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV-2 (COVID-19) nucleocapsid antibody (GTX135357)_ELISA | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV-2 (COVID-19) nucleocapsid protein (GTX135357-pro) | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV-2 (COVID-19) spike antibody (GTX135360)_ELISA | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genetic Analysis AS | Commercial: GA-map COVID-19 Fecal Test | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genetic PCR Solutions | Commercial: CoVID-19 dtec-RT-qPCR Test | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Genetic PCR Solutions | Commercial: GPS 2019-nCoV qPCR kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genetic PCR solutions; Genetic Analysis Strategies S.L. | Commercial: CoVID-19 dtec-RT-qPCR Test | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Genetron | Commercial: Detection Kit for Novel Coronavirus (SARS-CoV-2) RNA (PCR-Fluorescence Probing) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genitech NSAN Pharmaceutical Pvt. Ltd | Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: GenMark Diagnostics | Commercial: ePlex SARS-CoV-2 Test | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Genmark Saglik Urunleri Ith. Ihr. ve Tic. Ltd Sti. | Commercial: geneMAP 2019-nCoV (SARS-CoV-2) Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genmark Saglik Urunleri Ith. Ihr. ve Tic. Ltd Sti. | Commercial: geneMAP 2019-nCoV (SARS-CoV-2) Rapid Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Genmark Saglik Urunleri Ith. Ihr. ve Tic. Ltd Sti. | Commercial: geneMAP Respiratory Viral PCR Panel 2 (2019-nCoV, Inf A/B, RSV A/B) | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genomica Sau | Commercial: CLART COVID-19 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genomica Sau | Commercial: qCOVID-19 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genomictree, Inc | Commercial: AccuraTect RT-qPCR SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: GenoSensor | Commercial: GS COVID-19 RT-PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Genrui Biotech Inc | Commercial: Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Genrui Biotech Inc | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genrui Biotech Inc. | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: GenScript | Commercial: 2019-nCoV qRT-PCR Detection Assay | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: GenScript | Commercial: SARS-CoV-2 Spike S1-RBD IgG&IgM ELISA Detection Kit | Method: ELISA | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc | Commercial: COVID-19/Flu A/B Antigen Combo Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc | Commercial: GenSure COVID-19 Antigen Rapid Kit (REF: P2004) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc | Commercial: GenSure COVID-19 IgG/IgM Rapid Test (REF: P2002) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc | Commercial: GenSure COVID-19 IgM Rapid Test (REF: P2001) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: GenSure COVID-19 Neutralizing Antibody Test (Fluorescence) | Method: Immunoassay | Target: Antibody | Format: Manual | 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: Getein Biotech, Inc | Commercial: Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech, Inc | Commercial: Novel Coronavirus Real Time PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech, Inc | Commercial: One Step Test for Novel Coronavirus(2019-nCoV) IgM/IgG antibody (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech, Inc. | Commercial: SARS-CoV-2 Antigen (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: GFE | Commercial: SARS-CoV-2 PCR Reagent Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: GNA Biosolutions GmbH | Commercial: Sars-CoV-2 Detection Kit on portable PCA Analyzer | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Gnomegen | Commercial: Gnomegen COVID-19 RT-Digital PCR Detection Kit | Method: Digital-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Goldsite Diagnostics Inc | Commercial: SARS-CoV-2 Antigen Kit (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Goldsite Diagnostics Inc | Commercial: SARS-CoV-2 IgG/IgM Kit (manual) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Goldsite Diagnostics Inc. | Commercial: SARS-CoV-2 Real-time RT-PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Great Basin – Vela Operations | Commercial: SARS-CoV-2 Direct Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Green Cross Medical Science Corp. | Commercial: GENEDIA W COVID-19 Ag | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Green Cross Medical Science Corp. | Commercial: GENEDIA W COVID-19 Colorimetric LAMP premix kit | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Green Cross Medical Science Corp. | Commercial: GENEDIA W COVID-19 Real Time RT-PCR kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Green Cross Medical Science Corp. | Commercial: GENEDIA W ONE COVID 19 IgM&IgG | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV Antigen Test Kit (colloidal gold method) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV Neutralizing Antibody Test Kit (colloidal gold method) | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV Neutralizing Antibody Test Kit (Fluorescent immunochromatography) | Method: Immunochromatography | Target: Antibody | Format: Lab-based | 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