| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Centers for Disease Control and Prevention | Commercial: CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (CDC) | Device ID: 120 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Chembio Diagnostic Systems | Commercial: DPP COVID-19 IgM/IgG System | Device ID: 669 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Children's Hospital of Philadelphia Infectious Disease Diagnostics Laboratory | Commercial: SARS-CoV-2 RT-PCR test | Device ID: 713 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Chinese National Institute for Viral Disease Control and Prevention | Commercial: New coronavirus nucleic acid assay | Device ID: 127 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: ChromaCode | Commercial: ChromaCode COVID-19 Six Target Single Well Assay | Device ID: 128 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: CirrusDx Laboratories | Commercial: CirrusDx SARS-CoV-2 Assay | Device ID: 715 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: CoronaCide | Commercial: CoronaCide | Device ID: 341 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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: 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: 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: 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: 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: 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: Creative Diagnostics | Commercial: SARS-COV-2 Total Antibody ELISA Kit | Device ID: 137 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: CTK Biotech Inc. | Commercial: OnSite COVID-19 IgG/IgM | Device ID: 535 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Curative Inc. (in conjunction with KorvaLabs Inc) | Commercial: Curative-Korva SARS-Cov-2 Assay | Device ID: 536 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: DART Diagnostics | Commercial: DART COVID-19 | Device ID: 145 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Denka Seiken Co. Ltd. | Commercial: QuickNavi-COVID19 | Device ID: 780 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Diagnostic Solutions Laboratory | Commercial: COVID-19 Assay | Device ID: 146 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Diasia Biomedical Technology Co. Ltd. | Commercial: Diagnostic Kit for SARS-CoV-2 Nucleic Acid(RT-PCR) | Device ID: 2140 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: No | Manufacturer: Diatherix Eurofins Laboratory | Commercial: SARS-CoV-2 PCR Test | Device ID: 717 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Diazyme Laboratories | Commercial: Diazyme DZ-LITE SARS-CoV-2 IgG | Device ID: 670 | Method: Immunoassay | Target: Antibody, IgG | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Diazyme Laboratories | Commercial: Diazyme DZ-LITE SARS-CoV-2 IgM CLIA kit | Device ID: 1416 | Method: CLIA | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Diazyme Laboratories | Commercial: Macurra SARS-CoV-2 PCR Kit | Device ID: 1417 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: DNA Software Inc. | Commercial: Upper Respiratory Virus Panel, multiplex PCR, COVID-19, Influenza A B | Device ID: 472 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Dynamic Code AB | Commercial: Covid-19 PCR | Device ID: 2550 | Method: RT-PCR | Target: | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Eachy Biopharmaceuticals | Commercial: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) | Device ID: 671 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Eagle Biosciences Inc. | Commercial: COVID-19 IgG ELISA Assay | Device ID: 154 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Eagle Biosciences Inc. | Commercial: COVID-19 IgM ELISA Assay | Device ID: 153 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Ebram Produtos Laboratoriais Ltd. | Commercial: CORONAVÍRUS IgG/IgM (COVID-19) | Device ID: 543 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Eco Diagnostica Ltd.a | Commercial: COVID-19 IgG/IgM ECO Teste | Device ID: 672 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | 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: Elabscience | Commercial: Novel Coronavirus (SARS-CoV-2) Nucleic Acid Assay Kit (RT-PCR) | Device ID: 546 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, 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: EMG | Commercial: Detection Kit for the SARS-CoV-2 RNA Presence in Biological Material Using Real-Time (RUO) | Device ID: 782 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Epigentek Group Inc. | Commercial: SeroFlash SARS-CoV-2 IgM/IgG Antibody Detection Kit | Device ID: 1038 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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: Exact Sciences | Commercial: SARS-CoV-2 Test | Device ID: 719 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: FemtoDx | Commercial: COVID-19 Antibody Test | Device ID: 164 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: FemtoDx | Commercial: COVID-19 Rapid Home Nucleic Acid Test | Device ID: 165 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Fjord Diagnostics SDN | Commercial: Viral Transport Medium | Device ID: 551 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: FluroTest LLC | Commercial: CompleTest | Device ID: 553 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Fulgent Genetics/MedScan Laboratory | Commercial: COVID-19 | Device ID: 166 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Genalyte | Commercial: Maverick SARS-CoV-2 Multi-Antigen Serology Panel | Device ID: 721 | Method: Immunoassay | Target: Antigen | Format: Lab-based | 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 |
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