| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: GeneReach Biotechnology Corporation | Commercial: IQ REAL™ SARS-CoV-2 Qualitative System | Device ID: 2831 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: GeneReach Biotechnology Corporation | Commercial: POCKIT™ Central SARS CoV 2 ( orf 1ab ) Premix Reagent | Device ID: 2767 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: GeneReach Biotechnology Corporation | Commercial: taco™ Sample Storage Solution (For DNA/RNA use) | Device ID: 2764 | Method: | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Generi Biotech s.r.o. | Commercial: gb Sarbeco E (primary test) | Device ID: 784 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Generi Biotech s.r.o. | Commercial: gb Sarbeco N (primary test) | Device ID: 555 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Generi Biotech s.r.o. | Commercial: gb SARS-CoV-2 N (confirmation test) | Device ID: 785 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Generi Biotech s.r.o. | Commercial: gb SARS-CoV-2 RdRP (confirmation test) | Device ID: 556 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genes Laboratories | Commercial: GCdia™ COVID-19 Fast Detection Kit | Device ID: 2656 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genes Laboratories | Commercial: GCdia™ COVID-19 Fast Detection Kit | Device ID: 25578 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genes2me Private LTD | Commercial: RapiCov Rapid Antigen Test Kit for COVID‐19 | Device ID: 4072 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genesig | Commercial: genesig Real-Time PCR COVID-19 | Device ID: 301 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: GeneSign Biotech (Xiamen) Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Lateral Flow Assay) | Device ID: 3075 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genesprint Group Limited | Commercial: Chlamydia Antigen Rapid Test Cassette | Device ID: 3138 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Genesprint Group Limited | Commercial: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV- 2 | Device ID: 1609 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genesprint Group Limited | Commercial: Neisseria Gonorrhoeae Antigen Rapid Test Cassette | Device ID: 3139 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Genesprint Group Limited | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 1595 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genesprint Group Limited | Commercial: Trichomonas Vaginalis Antigen Rapid Test Cassette | Device ID: 3140 | Method: Immunoassay | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: GeneStore France SAS | Commercial: 1S Détection Expert | Device ID: 2772 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: GeneStore France SAS | Commercial: Detection Expert 1S © SARS CoV-2 kit | Device ID: 2699 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genesystem Co. Ltd. | Commercial: SMARTCHEK SARS-CoV2 Detection Kit | Device ID: 853 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genetic Analysis AS | Commercial: GA-map COVID-19 Fecal Test | Device ID: 1171 | 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 | Device ID: 1207 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genetic PCR Solutions | Commercial: CoVID-19 dtec-RT-qPCR-Test | Device ID: 1157 | 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) | Device ID: 722 | 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) | Device ID: 563 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genius Pharmaceutical AG | Commercial: GENnasal SARS-CoV-2 Antigen Rapid Test | Device ID: 3149 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genius Pharmaceutical AG | Commercial: GENnow SARS-CoV-2 Antigen Rapid Test Cassette | Device ID: 3127 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genmark Saglik Urunleri | Commercial: geneMAP 2019-nCoV (SARS-CoV-2) Detection Kit | Device ID: 1222 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genmark Saglik Urunleri | Commercial: geneMAP 2019-nCoV (SARS-CoV-2) Rapid Detection Kit | Device ID: 1059 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Genmark Saglik Urunleri | Commercial: geneMAP Respiratory Viral PCR Panel 2 (2019-nCoV, Inf A/B, RSV A/B) | Device ID: 1221 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genobio Pharmaceutical Co. Ltd. | Commercial: Virusee® SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) | Device ID: 2642 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genobio Pharmaceutical Co. Ltd. | Commercial: Virusee® SARS-CoV-2 Molecular Detection Kit (Real-time RT-PCR) | Device ID: 2752 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genomica Sau | Commercial: CLART COVID-19 | Device ID: 186 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genomica Sau | Commercial: qCOVID-19 | Device ID: 185 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genomictree Inc. | Commercial: AccuraTect RT-qPCR SARS-CoV-2 | Device ID: 187 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genomtec SA | Commercial: GenomtecSARS-CoV-2 EvaGreen® RT-LAMP CE-IVD Duo Kit | Device ID: 2000 | Method: LAMP | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genomtec SA | Commercial: SARS-CoV-2 EvaGreen® Direct-RT-LAMP CE-IVD Kit | Device ID: 2446 | Method: LAMP | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genrui Biotech Inc. | Commercial: Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold) | Device ID: 786 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Genrui Biotech Inc. | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) | Device ID: 1925 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genrui Biotech Inc. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2012 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genrui Biotech Inc. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) (Self-Testing) | Device ID: 4159 | Method: Immunochromatography | Target: Antigen | Format: Manual, Other | Go to details |
| CE Marking: Yes | Manufacturer: GenScript Biotech Corporation | Commercial: cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit | Device ID: 2860 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: COVID-19/Flu A/B Antigen Combo Rapid Test | Device ID: 1454 | 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 | Device ID: 1253 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: GenSure COVID-19 Antigen Rapid Test Kit | Device ID: 2853 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: GenSure COVID-19 IgG/IgM Rapid Test (REF: P2002) | Device ID: 565 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: GenSure COVID-19 IgM Rapid Test (REF: P2001) | Device ID: 566 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: GenSure COVID-19 Neutralizing Antibody Test (Fluorescence) | Device ID: 1826 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: GenSure COVID-19 Neutralizing Antibody Test (Latex) | Device ID: 2112 | Method: Immunoassay | Target: Antibody | Format: | Go to details |
| CE Marking: Yes | Manufacturer: gerbion GmbH & Co. | Commercial: KG virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0 | Device ID: 567 | 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