| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Vircell s.l. | Commercial: AMPLIRUN CORONAVIRUS SARS (2003) RNA CONTROL | Device ID: 490 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: AndLucky SARS CoV-2 Antigen Rapid Test, Anterior Nasal Check (minimal-invasiv) | Device ID: 2008 | Method: Immunoassay | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Labtest Diagnostica | Commercial: ANTI COVID-19 IGG/IGM RAPID TEST | Device ID: 578 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: RPC Diagnostic Systems | Commercial: Anti-SARS-CoV-2 enzyme immunoassay for the detection of antibodies to SARS-CoV-2 (COVID-19) | Device ID: 340 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Mediagnost | Commercial: Anti-SARS-CoV-2 IgA ELISA | Device ID: 1626 | Method: ELISA | Target: Antibody, IgA | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Mediagnost | Commercial: Anti-SARS-CoV-2 IgM ELISA | Device ID: 1627 | Method: ELISA | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Academia Sinica | Commercial: Anti-SARS-CoV-2 nucleocapsid protein human IgM/IgG rapid detection kit | Device ID: 11 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Jiangxi YeLi Medical | Commercial: Apparatus Detection Kit for Novel Coronavirus 2019-nCoV RNA (RT-PCR Fluorescence Probing) | Device ID: 658 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Ativa Medical | Commercial: Ativa Enhanced Screen | Device ID: 42 | Method: Other | Target: Other | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Avellino Lab | Commercial: Avellino SARS-CoV-2/COVID-19 (AvellinoCoV2) | Device ID: 48 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Axium Bioresearch Inc. | Commercial: AxiumHealth COVID-19 IgG/IgM Antibody Test | Device ID: 775 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Baiya Phytopharm Co. Ltd. | Commercial: Baiya Rapid COVID-19 IgM/IgG test kit | Device ID: 50 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Bako Diagnostics | Commercial: BakoDx SARS-CoV-2 RNA test | Device ID: 704 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Trinity Biotech plc | Commercial: Bartels FlexTrans Medium | Device ID: 812 | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: Abbott | Commercial: BasePoint Covid-19 IgG/IgM Rapid test Device | Device ID: 1032 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Bio-Rad Laboratories Inc. | Commercial: Bio-Rad SARS CoV-2 ddPCR Assay | Device ID: 541 | Method: Digital-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Applied BioCode | Commercial: BioCode SARS CoV-2 Assay kit | Device ID: 1399 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: RapiGEN Inc. | Commercial: BIOCREDIT COVID-19 IgG | Device ID: 602 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Biodesix | Commercial: Biodesix SARS-CoV-2 Droplet Digital PCR (ddPCR ) Test | Device ID: 758 | Method: Digital-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: BioFire Diagnostics | Commercial: BioFire COVID-19 test | Device ID: 710 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: bioMérieux SA | Commercial: BIOFIRE Respiratory Panel 2.1 (RP2.1) | Device ID: 94 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Becton Dickinson | Commercial: BioGX SARS-CoV-2 Reagents for BD MAX System | Device ID: 518 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Nanjing BioPoint Diagnostics | Commercial: BioPoint SARS-CoV-2 dIgA/total antibody rapid test | Device ID: 290 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Access Bio Inc. | Commercial: CareStart COVID-19 IgM/IgG | Device ID: 506 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Wells Bio Inc. | Commercial: careUS COVID-19 IgM/IgG | Device ID: 632 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| 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: Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory | Commercial: CDI Enhanced COVID-19 Test | Device ID: 726 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Boston Children's Hospital Infectious Diseases Diagnostic Laboratory (IDDL) | Commercial: Childrens-Altona-SARS-CoV-2 assay | Device ID: 712 | 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: 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: 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: Luminostics Inc. | Commercial: CLIP-COVID19 (smartphone-read out high sensivity antigen detection test) | Device ID: 267 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: CanaryQ | Commercial: Collection tools and blood separation for serology diagnostics for SARS-CoV-2 | Device ID: 817 | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: Anhui Deep Blue Medical Technology Co. Ltd. | Commercial: Colloidal gold strip for SARS-CoV-2 IgG & IgM | Device ID: 34 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Fenghua Bioengineering Co. Ltd. | Commercial: Combined Detection Kit for Novel Coronavirus (2019-nCoV) IgM/IgG Antibody | Device ID: 199 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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: Applied Biomedical LLC | Commercial: Confidence COVID-19 Rapid Test | Device ID: 767 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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: Beijing Hotgen Biotech Co. Ltd. | Commercial: Coronavirus (2019-nCoV) -Antigentest | Device ID: 2292 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Coronavirus (2019-nCoV) -Antigentest-Speichel | Device ID: 2293 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Beijing O&D Biotech Co. Ltd. | Commercial: Coronavirus disease (COVID-19) Total Antibody Rapid Test (Colloidal Gold) | Device ID: 667 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Institute of Process Engineering Chinese Academy of Sciences | Commercial: Coronavirus Disease 2019 (COVID-19) Nucleic Acid Testing Kit (CAMP-based) | Device ID: 479 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Quest Diagnostics | Commercial: Coronavirus Disease 2019 (COVID-19) Test | Device ID: 330 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: MedicalSystem Biotechnology Co. Ltd. | Commercial: Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit | Device ID: 735 | Method: Immunoassay | Target: Antibody | Format: Lab-based | 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: Viracor Eurofins | Commercial: Coronavirus SARS-CoV-2 RT-PCR assay | Device ID: 421 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Ipsum Diagnostics | Commercial: COV-19 IDx assay | Device ID: 728 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: ARDİ MEDİKAL ARAŞTIRMA VE DİAGNOSTİK ÜRÜNLERİ SAN. TİC. LTD. ŞTİ. | Commercial: CoVard Covid-19 Nasal Antigen Test Kit | Device ID: 3568 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: ARDİ MEDİKAL ARAŞTIRMA VE DİAGNOSTİK ÜRÜNLERİ SAN. TİC. LTD. ŞTİ. | Commercial: CoVard Covid-19 Rapid Antigen Test Kit | Device ID: 4000 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Medsource Ozone Biomedicals | Commercial: COVID 19 IgG IgM Rapid Test | Device ID: 583 | 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