| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Guangzhou Hybribio Medicine Technology Ltd. | Commercial: Respiratory Virus (IFVa/b + COVID-19) Real-Time PCR Kit | Device ID: 202 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: CapitalBio Technology | Commercial: Respiratory Virus Nucleic Acid Detection Kit (Isothermal Amplification Chip Method) | Device ID: 114 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Bright Line Research | Commercial: Rona 19 Screen Coronavirus (SARS-CoV-2) IgG/IgM Rapid Test | Device ID: 109 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangzhou FulenGen Co. Ltd. | Commercial: RT-qPCR based SARS-CoV-2 detection kit with SPRS (Spike-in Reference Standard) | Device ID: 200 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Ningbo Beautiful Life Medical Biotechnology Development Co. Ltd. | Commercial: Saliva SARS-Cov-2(2019-nCoV) Antigen Combined Test Kit (Nanocarbon Assay) | Device ID: 2250 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Biogenix Inc. Pvt Ltd. | Commercial: SARS CoV-2 IgG/IgM Ab Rapid Test | Device ID: 777 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Tersaco AG | Commercial: SARS CoV-2 IgG/IgM Rapid Test | Device ID: 1030 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV / SARS-CoV-2 (COVID-19) nucleocapsid antibody [6H3] (GTX632269)_ELISA | Device ID: 558 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV / SARS-CoV-2 (COVID-19) spike antibody [1A9] (GTX632604) | Device ID: 559 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Integrated DNA Technologies/Danaher | Commercial: SARS-CoV-2 (2019-nCoV) CDC qPCR Probe Assay | Device ID: 231 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Elabscience | Commercial: SARS-CoV-2 (2019-nCoV) IgG/IgM Lateral Flow Assay Kit (Whole Blood/ Serum/ Plasma) | Device ID: 547 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sino Biological | Commercial: SARS-CoV-2 (2019-nCoV) Nucleocapsid Detection ELISA Kit | Device ID: 905 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Creative Biolabs | Commercial: SARS-CoV-2 (2019-nCoV) Nucleoprotein Protein ELISA Kit | Device ID: 136 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Sino Biological | Commercial: SARS-CoV-2 (2019-nCoV) Spike Detection ELISA Kit | Device ID: 906 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Creative Biolabs | Commercial: SARS-CoV-2 (2019-nCoV) Spike Protein ELISA Kit | Device ID: 135 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Sino Biological | Commercial: SARS-CoV-2 (2019-nCoV) Spike RBD ELISA Kit | Device ID: 907 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV-2 (COVID-19) nucleocapsid antibody (GTX135357)_ELISA | Device ID: 560 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV-2 (COVID-19) nucleocapsid protein (GTX135357-pro) | Device ID: 561 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: ALIMETRIX Inc. | Commercial: SARS-CoV-2 (COVID-19) serological test | Device ID: 1427 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV-2 (COVID-19) spike antibody (GTX135360)_ELISA | Device ID: 562 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: BioRad | Commercial: SARS-CoV-2 / COVID-19 Assa | Device ID: 99 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: INNOVITA (Tangshan) Biological Technology Co. Ltd. | Commercial: SARS-CoV-2 antibody assay | Device ID: 641 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Kurabo Industries Ltd. | Commercial: SARS-CoV-2 Antibody IgM/IgG Testing Kit | Device ID: 254 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Creative Diagnostics | Commercial: SARS-CoV-2 Antigen ELISA Kit | Device ID: 140 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Shijiazhuang Hipro Biotechnology Co. Ltd. | Commercial: SARS-COV-2 ANTIGEN TEST KIT (COLLOIDAL GOLD) - SALIVA | Device ID: 2545 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Shenzhen Kisshealth Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (GICA)-Nasal(Anterioar) Swab | Device ID: 2660 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Shenzhen Kisshealth Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (GICA)-Saliva | Device ID: 2659 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Nationwide Children's Hospital | Commercial: SARS-CoV-2 Assay | Device ID: 739 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Integrity Laboratories | Commercial: SARS-CoV-2 Assay | Device ID: 727 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Aurora Biomed Inc. | Commercial: SARS-COV-2 Detection Kit for the VERSA Viral Detection workstation | Device ID: 45 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: GNA Biosolutions GmbH | Commercial: Sars-CoV-2 Detection Kit on portable PCA Analyzer | Device ID: 191 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Mammoth Biosciences | Commercial: SARS-CoV-2 DETECTR | Device ID: 273 | Method: CRISPR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Vela Diagnostics | Commercial: SARS-CoV-2 Direct Test | Device ID: 193 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Biodesix | Commercial: SARS-CoV-2 Droplet Digital PCR (ddPCR) test | Device ID: 709 | Method: Digital-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Sophonix Co. Ltd. | Commercial: SARS-CoV-2 IgG antibody test kit SARS-CoV-2 IgM antibody test (automated) | Device ID: 378 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Creative Diagnostics | Commercial: SARS-CoV-2 IgG ELISA Kit | Device ID: 138 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Viracor Eurofins | Commercial: SARS-CoV-2 IgG ELISA Test Kit | Device ID: 1622 | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Suzhou Kangheshun Medical Technology | Commercial: SARS-CoV-2 IgG/IgM Rapid Test Cassette | Device ID: 696 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Creative Diagnostics | Commercial: SARS-CoV-2 IgM ELISA Kit | Device ID: 139 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Shenzhen GeneBioHealth Co. Ltd. | Commercial: SARS-CoV-2 IgM IgG Test Kit (Colloidal Gold) | Device ID: 806 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Nanjing Liming BioProducts Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit | Device ID: 680 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: ShanXi Medical University | Commercial: SARS-COV-2 IgM/IgG antibody test (Colloidal Gold) | Device ID: 364 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: BioGX | Commercial: SARS-CoV-2 in the Open System Reagents for BD MAX | Device ID: 459 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: BioRad | Commercial: SARS-CoV-2 Negative | Device ID: 98 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Beijing Genskey Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (RT-qPCR with Taqman-Probe) | Device ID: 64 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Shanghai Kehua Bio-engineering Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Test | Device ID: 361 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Tebsun Bio-Tech Development Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Test (LAMP) | Device ID: 204 | Method: LAMP | Target: Nucleic acid | Format: Automated, Lab-based, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Academia Sinica | Commercial: SARS-CoV-2 Nucleocapsid Protein Rapid Detection Kit | Device ID: 12 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Assurance Scientific Laboratories | Commercial: SARS-COV-2 PANEL | Device ID: 1400 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: GFE | Commercial: SARS-CoV-2 PCR Reagent Kit | Device ID: 822 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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