| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: OPTOLANE Technologies Inc. | Commercial: Dr. PCR COVID-19 Viral Load 20K | Device ID: 303 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: No | Manufacturer: Sys2diag | Commercial: EasyCOV | Device ID: 1045 | 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 | Device ID: 182 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Edinburgh Genetics Limited | Commercial: Edinburgh Genetics Complete Whole Blood Collection Kit | Device ID: 544 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Edinburgh Genetics Limited | Commercial: Edinburgh Genetics Virus Swab Sampling Kit | Device ID: 545 | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: AnyGenes | Commercial: Efficient 2019-nCOV detection kit, one step RT-qPCR (N1 & N2) | Device ID: 513 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Creative Diagnostics | Commercial: ELISA: Anti-SARS-CoV-2 antibodies & NP antigen | Device ID: 908 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Bio-Techne | Commercial: Ella / Simple Plex COVID-19 16×4 Standard Panel | Device ID: 85 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | 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: No | Manufacturer: GenMark Diagnostics | Commercial: ePlex SARS-CoV-2 Test | Device ID: 184 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Erba Mannheim | Commercial: ErbaLisa COVID-19 IgM ELISA | Device ID: 534 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Randox Laboratories Ltd. | Commercial: Extended Coronavirus Array | Device ID: 334 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Prantae Solutions Pte Ltd. | Commercial: EyeRa-Covid | Device ID: 314 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: DNA Xperts Pvt Ltd. | Commercial: FAST RT-PCR KIT, Real time PCR kit for COVID19 detection | Device ID: 542 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Superbio Biomedical Technology (Nanjing) Co. Ltd. | Commercial: Fast SARS-CoV-2 lgM/lgG Antibody Detection Kit (Colloidal Gold) | Device ID: 240 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: MGI Tech Co. Ltd. | Commercial: Fast SARS-CoV-2 NAT with CRISPR assay by digital microfluidics automation | Device ID: 483 | Method: CRISPR | Target: Nucleic acid | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: CellSafe | Commercial: FastRT-qPCR COVID19 detection kit | Device ID: 119 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Qitian Gene Biotechnology Co. Ltd. | Commercial: Fluorescent RAA Detection for 2019-nCoV | Device ID: 239 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Medical & Biological Laboratories Co. Ltd. | Commercial: FLUOROSEARCH Novel Coronavirus (SARS-CoV-2) Detection Kit | Device ID: 274 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Hain Lifescience a Bruker company | Commercial: FluoroType® SARS-CoV-2 evo | Device ID: 2972 | Method: RT-PCR | Target: | Format: Semi-automated | Go to details |
| CE Marking: No | Manufacturer: Shanghai Fosun Long March Medical Science Co. Ltd. | Commercial: Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit | Device ID: 820 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Shanghai Fosun Long March Medical Science Co. Ltd. | Commercial: Fosun COVID-19 RT-PCR Detection Kit | Device ID: 720 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: NanoEntek | Commercial: FREND COVID-19 total Ab | Device ID: 1418 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Beijing Bohui Innovation Biotechnology Co. Ltd. | Commercial: Fully Automated 26 Plex RES Panel Assay | Device ID: 60 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Yantai Addcare Bio-Tech | Commercial: Fully Automated Nucleic Acid Extractor | Device ID: 1897 | Method: Other | Target: Nucleic acid | Format: Fully automated (robot) | Go to details |
| CE Marking: No | Manufacturer: Yantai Addcare Bio-Tech | Commercial: Fully Automated Nucleic Acid Extractor (magnetic beads adsorption) | Device ID: 1898 | Method: Other | Target: Nucleic acid | Format: Other | 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 |
| 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: 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: 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: 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: No | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. | Commercial: Genonto RapidTest10 COVID-19 IgG/IgM Antibody Rapid Test Kit | Device ID: 707 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Gnomegen | Commercial: Gnomegen COVID-19 RT-Digital PCR Detection Kit | Device ID: 724 | Method: Digital-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Genetic PCR Solutions | Commercial: GPS 2019-nCoV qPCR kit | Device ID: 896 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Vela Diagnostics | Commercial: Great Basin System SARS-CoV-2 Direct Test | Device ID: 813 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: GenoSensor | Commercial: GS COVID-19 RT-PCR Kit | Device ID: 723 | 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 | Device ID: 714 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Predigen Inc. | Commercial: HR-PreV | Device ID: 315 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) IgM Rapid Test | Device ID: 247 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) Nucleocapsid Protein IgG ELISA (manual) | Device ID: 249 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) Spike Protein IgG ELISA (manual) | Device ID: 251 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Quansys Biosciences | Commercial: Human COVID-19 (2-plex) | Device ID: 327 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human SARS-CoV-2 (Covid-19) Qualitative ELISA (manual) | Device ID: 253 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Innovative Diagnostics | Commercial: ID Screen® SARS-CoV-2 Double Antigen Multi-species | Device ID: 1727 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Zhengzhou Fortune Bioscience Co. Ltd. | Commercial: IgG/IgM Antibody Rapid Test Kits (Colloidal Gold Immunochromatography method) | Device ID: 699 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: InBios International | Commercial: InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit | Device ID: 224 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Beijing Infervision Technology Co. Ltd. | Commercial: InferRead CT Pneumonia | Device ID: 65 | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: Innovation Scientific Pty Ltd. | Commercial: InnoScreenTM COVID-19 Antigen Rapid Test Device | Device ID: 2566 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Innovation Scientific Pty Ltd. | Commercial: InnoScreenTM COVID-19 IgG/IgM Rapid Test Device | Device ID: 2565 | Method: Immunochromatography | Target: Antibody, IgG, IgM | 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