CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun Flu/SC2 qPCR | Device ID: 2720 | Method: | Target: | Format: | Go to details |
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun FluA/FluB/2019-nCoV qPCR | Device ID: 2714 | Method: | Target: | Format: | Go to details |
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun FluA/FluB/SC2 qPCR | Device ID: 2719 | Method: | Target: | Format: | Go to details |
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun Instant COVID-19 Ag | Device ID: 2729 | Method: | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SARs-CoV-2 CRISPR | Device ID: 2717 | Method: CRISPR | Target: | Format: | Go to details |
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SARS-CoV-2 Neutralization Antibody Detection Kit | Device ID: 2730 | Method: | Target: Antibody | Format: | Go to details |
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SARS-CoV-2 Neutralization Antibody Rapid | Device ID: 2726 | Method: | Target: Antibody | Format: | Go to details |
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SARS-CoV-2 Neutralization Antibody Rapid (Immunofluorescence) | Device ID: 2727 | Method: Immunoassay | Target: Antibody | Format: | Go to details |
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SC2 Ag Rapid | Device ID: 2723 | Method: | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SC2 qPCR | Device ID: 2721 | Method: | Target: | Format: | Go to details |
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SC2 qPCR Rapid | Device ID: 2722 | Method: | Target: | Format: | Go to details |
CE Marking: Yes | Manufacturer: FUJIAN ERCON MEDICAL MANAGEMENT Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit | Device ID: 3028 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: FUJIFILM Corporation | Commercial: FUJIFILM COVID-19 Ag Test | Device ID: 2428 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Fujirebio | Commercial: ESPLINE SARS-CoV-2 | Device ID: 2147 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Fujirebio Inc. | Commercial: Lumipulse G SARS-CoV-2 Ag | Device ID: 2124 | Method: Immunoassay | Target: Antigen | Format: Automated, Fully automated (robot), Lab-based | Go to details |
CE Marking: No | Manufacturer: Fulgent Genetics/MedScan Laboratory | Commercial: COVID-19 | Device ID: 166 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: GA Generic Assays GmbH | Commercial: GA CoV-2 Antigen Rapid | Device ID: 1580 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: GA Generic Assays GmbH | Commercial: GA CoV-2 Antigen Rapid Test | Device ID: 1855 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: GA Generic Assays GmbH | Commercial: GA CoV-2 IgG/IgM/IgG+ | Device ID: 554 | Method: ELISA | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Gaobeidian PRISES Biotechnology Co. Ltd. | Commercial: SARS-COV-2 Antigen Test | Device ID: 2781 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: GC Medical Science Corp. | Commercial: GENEDIA W COVID-19 Ag | Device ID: 1144 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: GC Medical Science Corp. | Commercial: GENEDIA W COVID-19 Ag (643K) | Device ID: 3190 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: GenaBio Diagnostics Inc. | Commercial: GenaBio SARS-CoV-2 Antigen Lateral Flow Test | Device ID: 1585 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: GenaBio Diagnostics Inc. | Commercial: SARS-CoV-2 IgM/IgG (GICA) Test | Device ID: 1576 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Genalyte | Commercial: Maverick SARS-CoV-2 Multi-Antigen Serology Panel | Device ID: 721 | Method: Immunoassay | Target: Antigen | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: GenBody Inc. | Commercial: GenBody COVID-19 Ag | Device ID: 1244 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: GenBody Inc. | Commercial: GenBody COVID-19 IgM/IgG | Device ID: 169 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: GenBody Inc. | Commercial: GenBody FIA COVID-19 Ag | Device ID: 1297 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: GenBody Inc. | Commercial: GenBody FIA COVID-19 IgM/IgG | Device ID: 170 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Gencurix Inc. | Commercial: GenePro COVID-19 Detection Test | Device ID: 171 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Gencurix Inc. | Commercial: GenePro SARS-CoV-2 Test | Device ID: 172 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: Gene Biosystems | Commercial: Gene Bio COVID-19 Qualitative Real Time PCR Kit Ver. 1.0 | Device ID: 173 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Genecast Co. Ltd. | Commercial: SMARTROL™ 2019-nCoV Detection Kit v1 | Device ID: 2840 | Method: RT-PCR | Target: | Format: Lab-based, Manual | Go to details |
CE Marking: Yes | Manufacturer: genedrive | Commercial: COV19-ID Kit | Device ID: 2524 | Method: LAMP | Target: | Format: Near POC / POC, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: genedrive | Commercial: Genedrive 96 SARS-CoV- Kit | Device ID: 925 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: genedrive | Commercial: Genedrive 96 SARS-CoV-2 Kit | Device ID: 174 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based | Go to details |
CE Marking: Yes | Manufacturer: GeneFirst Ltd. | Commercial: COVID-19 Detection Kit | Device ID: 926 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
CE Marking: No | Manufacturer: GeneFirst Ltd. | Commercial: Respiratory Pathogen Panel | Device ID: 176 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Genelogic Research Limited | Commercial: Genelogic COVID-19 IgM/IgG Antibody Test Kit | Device ID: 850 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: GeneMatrix Inc. | Commercial: NeoPlex COVID-19 Detection Kit | Device ID: 657 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: GeneMatrix Inc. | Commercial: NeoPlex™ COVID-19 FAST | Device ID: 2838 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
CE Marking: Yes | Manufacturer: GeneMe | Commercial: Advanced One Step FAST Covi19 KIT Two Genes Set | Device ID: 177 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: geneOmbio Technologies Pvt. Ltd. | Commercial: geneOmbio COVID-19 rt-LAMP test | Device ID: 178 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: GeneProof a.s. | Commercial: GeneProof SARS-CoV- PCR Kit | Device ID: 927 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: GeneProof a.s. | Commercial: GeneProof SARS-CoV- Screening PCR Kit | Device ID: 928 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: GeneProof a.s. | Commercial: GeneProof SARS-CoV-2 PCR Kit | Device ID: 1061 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: GeneProof a.s. | Commercial: GeneProof SARS-CoV-2 Screening PCR Kit | Device ID: 1062 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: General Biologicals Corporation | Commercial: GB COVID-19 Ag POCT | Device ID: 4081 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: General Biologicals Corporation | Commercial: GB SARS-CoV-2 Ab ELISA | Device ID: 1586 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
CE Marking: No | Manufacturer: General Biologicals Corporation | Commercial: GB SARS-CoV-2 Real Time RT-PCR | Device ID: 179 | 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