| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Predigen Inc | Commercial: HR-PreV | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hoyotek Biomedical Co.,Ltd | Commercial: Hoyotek | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co., Ltd | Commercial: Hightop SARS-CoV-2 IgM/IgG Antibody Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co., Ltd | Commercial: Hightop COVID-19 IgM/IgG Ab Rapid Test Kit | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Hibergene | Commercial: Hibergene (lab-based or near-POC) | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: ChromaCode | Commercial: HDPCR SARS-CoV-2 real-time PCR assay | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Hayat Genetics Inc | Commercial: Hayat Rapid Colorimetric & Fluorimetric One Step LAMP SARS-CoV-2 Test Kit | Method: LAMP | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: GSD NovaPrime SARS-CoV- (COVID-19) | 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: No | Manufacturer: Vela Diagnostics | Commercial: Great Basin System SARS-CoV-2 Direct Test | Method: Immunoassay | Target: Antibody | Format: Lab-based | 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: 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: Philosys Co., Ltd. | Commercial: Gmate® COVID-19 Ag Saliva | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Philosys Co., Ltd. | Commercial: Gmate® COVID-19 Ag | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Medisys International SA Gmate Covid-19 | Commercial: Gmate Covid-19 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: GLINE-2019-nCoV NAb | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: GLINE-2019-nCoV IgM/IgG | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: GLINE-2019-nCoV IgA | Method: Immunoassay | Target: Antibody, IgA | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: GLINE-2019-nCoV Ag Saliva | Method: | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: GLINE-2019-nCoV Ag | Method: | Target: Antigen | Format: Manual, 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: 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 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 Antigen Rapid Kit (REF: P2004) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Genonto RapidTest10 COVID-19 IgG/IgM Antibody Rapid Test Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Abacus Diagnostica | Commercial: GenomEra SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Applied Biological Materials Inc | Commercial: GenomeCov9 IgM/IgG Rapid Test Kit | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Applied Biological Materials Inc | Commercial: GenomeCoV9 Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Medical Innovation Ventures Sdn Bhd. | Commercial: GenoAmp Real-Time RT-PCR SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Immunospark s.r.l. | Commercial: Genespark SARS-CoV2 Quantitative detection of SARS-CoV2 genome | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Primerdesign, Novacyt | Commercial: genesig(R) Coronavirus (COVID-19) Rt-PCR assay | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genesig | Commercial: genesig Real-Time PCR COVID-19 | 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 | 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 | 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 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: GeneProof a.s. | Commercial: GeneProof SARS-CoV- PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Gencurix Inc | Commercial: GenePro SARS-CoV-2 Test | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Gencurix Inc | Commercial: GenePro COVID-19 Detection Test | 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 | Method: LAMP | Target: Nucleic acid | Format: Manual | 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: 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 2019-nCoV (SARS-CoV-2) Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genelogic Research Limited | Commercial: Genelogic COVID-19 IgM/IgG Antibody Test Kit | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OsangHealthcare | Commercial: GeneFinder COVID-19 RealAmp Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: ELITech-OSANG Healthcare | Commercial: GeneFinder COVID-19 Plus RealAmp Kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OSANG Healthcare Co., Ltd. | Commercial: GeneFinder COVID-19 Fast RealAmp Kit | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: OSANG Healthcare Co., Ltd. | Commercial: GeneFinder COVID-19 Ag Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Genedrive plc | Commercial: Genedrive 96 SARS-CoV-2 Kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Genedrive plc | Commercial: Genedrive 96 SARS-CoV- 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 |
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