| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: OSANG Healthcare Co. Ltd. | Commercial: GeneFinder™ COVID-19 Ag Dipstick Self Test | Device ID: 3100 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: OSANG Healthcare Co. Ltd. | Commercial: GeneFinder™ COVID-19 Ag Plus Rapid Test | Device ID: 2741 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: OSANG Healthcare Co. Ltd. | Commercial: GeneFinder™ COVID-19 Ag Self Test | Device ID: 2806 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: OSANG Healthcare Co. Ltd. | Commercial: GeneFinder™ COVID-19 IgG/IgM Rapid Test | Device ID: 3102 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: OSANG Healthcare Co. Ltd. | Commercial: Immuno-on COVID-19 IgG Test | Device ID: 3105 | Method: Immunoassay | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: OZO Diamond - OZO SARS-CoV-2 IgM + IgG Method | Device ID: 474 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: OZO Gold - OZO SARS-CoV-2 IgG Method | Device ID: 475 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: OZO Silver - OZO SARS-CoV-2 IgM Method | Device ID: 476 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: Simcere Novel Coronavirus (2019-NCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Device ID: 860 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Panion & BF Biotech Inc. | Commercial: Vstrip Covid-19 Antigen Rapid Test | Device ID: 1379 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pantest SA | Commercial: Pantest Coronavirus Ag | Device ID: 1270 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pantest SA | Commercial: Pantest Coronavirus Ag (Nasopharyngeal Swab) | Device ID: 2271 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pantest SA | Commercial: Pantest de Coronavirus IgM/IgG 2019-n-CoV | Device ID: 1003 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Paragon Genomics Inc. | Commercial: CleanPlex SARS-CoV-2 Research and Surveillance NGS Panel | Device ID: 305 | Method: Other | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Pardee lab | Commercial: En Carta SARS-CoV-2 | Device ID: 549 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: PathoFinder | Commercial: RealAccurate Quadruplex Corona-plus PCR Kit | Device ID: 591 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: PaxGen Bio Co. Ltd. | Commercial: Dr. PCR COVID-19 Viral Load 20K | Device ID: 306 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PaxGen Bio Co. Ltd. | Commercial: PaxView COVID-19 real time RT-PCR | Device ID: 866 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc. | Commercial: PCL COVID19 Ag Gold | Device ID: 2243 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc. | Commercial: PCL COVID19 Ag Rapid FIA | Device ID: 308 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc. | Commercial: PCL COVID19 IgG/IgM Rapid Gold | Device ID: 307 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc. | Commercial: PCL SELF TEST - COVID19 Ag | Device ID: 3694 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc. | Commercial: PCLMD nCoV one step RT-PCR Kit | Device ID: 593 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: PCR BioSystems | Commercial: qPCRbio Probe 1-step-go Kit | Device ID: 887 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: PentaBase | Commercial: CoviDetect™ COVID-19 Multiplex RT-qPCR Assay | Device ID: 2915 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: PEPperPRINT GmbH | Commercial: PEPperCHIP SARS-CoV-2 Proteome Microarray (manual) | Device ID: 309 | Method: Other | Target: Other | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: PerGrande BioTech Development Co. Ltd. | Commercial: SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay) | Device ID: 310 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PerGrande BioTech Development Co. Ltd. | Commercial: SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay) | Device ID: 2116 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PerGrande BioTech Development Co. Ltd. | Commercial: SARS-CoV-2 Antigen Detection Kit (Sampling by gargle or oropharyngeal wash) | Device ID: 2121 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PerkinElmer Inc. | Commercial: PerkinElmer New Coronavirus Nucleic Acid Detection Kit | Device ID: 743 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PerkinElmer Inc. | Commercial: PerkinElmer SARS-CoV-2 Realtime RT-PCR Assay | Device ID: 311 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pharmact (Berlin) | Commercial: SARS-CoV-2 Rapid TesIgM/IgG | Device ID: 485 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pharmact (Berlin) | Commercial: SARS-COV-2 Rapid Test | Device ID: 501 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pharmaline AS | Commercial: LAMPIGEN COVID19 RT-LAMP PCR KIT | Device ID: 1825 | Method: LAMP | Target: Nucleic acid | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pharmaline AS | Commercial: RAPIDIGEN COVID19 AG IMMUNOASSAY | Device ID: 1823 | Method: Immunochromatography | Target: Antigen | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: PharmaNona | Commercial: FOAMING TEST | Device ID: 1447 | Method: Other | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Pharmatech | Commercial: COVID19 IgG/IgM Rapid Test | Device ID: 686 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PHASE Scientific International Limited | Commercial: INDICAID COVID-19 Rapid Antigen Self-Test | Device ID: 3150 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PHASE Scientific International Limited | Commercial: INDICAID COVID-19 Rapid Antigen Test Kit | Device ID: 3014 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Philosys | Commercial: Gmate COVID-19 Neutralizing antibody | Device ID: 2861 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Philosys | Commercial: Gmate® COVID-19 Ag | Device ID: 1611 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Philosys | Commercial: Gmate® COVID-19 Ag Saliva | Device ID: 1854 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Philosys | Commercial: SoluM COVID 19-Ag | Device ID: 2830 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Philosys | Commercial: SoluM COVID-19 Ag Neutralizing Antibody | Device ID: 2916 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Philosys | Commercial: SoluM COVID-19 Ag Saliva | Device ID: 2829 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Phosphorus Diagnostics | Commercial: COVID-19 RT-qPCR Test | Device ID: 1407 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pierenkemper GmbH | Commercial: (SARS-CoV-2) Antigen Rapid Test COVIDENT COVID-19 | Device ID: 2672 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pierenkemper GmbH | Commercial: (SARS-CoV-2) Antigen Rapid Test COVIDENT COVID-19 / Saliva | Device ID: 2197 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Pinpoint Science Inc. | Commercial: Pinpoint Covid-19 Screening Assay – Electrical detection of SARS-CoV-2 nucleocapsid protein using nanosensors and aptamer | Device ID: 312 | Method: Other | Target: Other | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pishtaz Teb Diagnostics | Commercial: COVID-19 One-Step COVID-19 RT-PCR Kit | Device ID: 595 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, 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