| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Applied Biomedical, LLC | Commercial: Confidence COVID-19 Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: FluroTest LLC | Commercial: CompleTest | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Fenghua Bioengineering , Co. LTD | Commercial: Combined Detection Kit for Novel Coronavirus (2019-nCoV) IgM/IgG Antibody | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Anhui Deep Blue Medical Technology Co., Ltd | Commercial: Colloidal gold strip for SARS-CoV-2 IgG & IgM | Method: Immunoassay | Target: Antibody, IgG, IgM | 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 | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: Luminostics, Inc | Commercial: CLIP-COVID19 (smartphone-read out high sensivity antigen detection test) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Paragon Genomics Inc | Commercial: CleanPlex SARS-CoV-2 Research and Surveillance NGS Panel | Method: Other | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: CirrusDx Laboratories | Commercial: CirrusDx SARS-CoV-2 Assay | 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 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Boston Children's Hospital Infectious Diseases Diagnostic Laboratory (IDDL) | Commercial: Childrens-Altona-SARS-CoV-2 assay | 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 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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) | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Wells Bio, Inc | Commercial: careUS COVID-19 IgM/IgG | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Access Bio, Inc | Commercial: CareStart COVID-19 IgM/IgG | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Nanjing BioPoint Diagnostics | Commercial: BioPoint SARS-CoV-2 dIgA/total antibody rapid test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Becton Dickinson | Commercial: BioGX SARS-CoV-2 Reagents for BD MAX System | 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) | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: BioFire Defense, LLC | Commercial: BioFire COVID-19 test | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Biodesix | Commercial: Biodesix SARS-CoV-2 Droplet Digital PCR (ddPCR ) Test | Method: Digital-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: RapiGEN Inc | Commercial: BIOCREDIT COVID-19 IgG | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Applied BioCode | Commercial: BioCode SARS CoV-2 Assay kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Bio-Rad Laboratories, Inc | Commercial: Bio-Rad SARS CoV-2 ddPCR Assay | Method: Digital-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Abbott | Commercial: BasePoint Covid-19 IgG/IgM Rapid test Device | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Trinity Biotech | Commercial: Bartels FlexTrans Medium | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: Bako Diagnostics | Commercial: BakoDx SARS-CoV-2 RNA test | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Baiya Phytopharm, Co., Ltd | Commercial: Baiya Rapid COVID-19 IgM/IgG test kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Axium Bioresearch Inc | Commercial: AxiumHealth COVID-19 IgG/IgM Antibody Test | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Avellino Lab | Commercial: Avellino SARS-CoV-2/COVID-19 (AvellinoCoV2) | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Beijing Bohui Innovation Biotechnology | Commercial: Automated SarS-CoV-2 NAT | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Ativa Medical | Commercial: Ativa Enhanced Screen | Method: Other | Target: Other | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Luminex Corp. | Commercial: ARIES SARS-CoV-2 Assay | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Jiangxi YeLi Medical | Commercial: Apparatus Detection Kit for Novel Coronavirus 2019-nCoV RNA (RT-PCR Fluorescence Probing) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Autobio Diagnostics Co., Ltd | Commercial: Anti-SARS-CoV-2 Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Academia Sinica | Commercial: Anti-SARS-CoV-2 nucleocapsid protein human IgM/IgG rapid detection kit | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Mediagnost | Commercial: Anti-SARS-CoV-2 IgM ELISA | Method: ELISA | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Mediagnost | Commercial: Anti-SARS-CoV-2 IgA ELISA | Method: ELISA | Target: Antibody, IgA | Format: Manual | 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) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Labtest Diagnostica | Commercial: ANTI COVID-19 IGG/IGM RAPID TEST | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Vircell S.L. | Commercial: AMPLIRUN TOTAL SARS-CoV-2 CONTROL (SWAB) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Vircell S.L. | Commercial: AMPLIRUN SARS-CoV-2 RNA CONTROL | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Vircell S.L. | Commercial: AMPLIRUN CORONAVIRUS SARS (2003) RNA CONTROL | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Canary Health Technologies | Commercial: AiroStotleCV19 (Breath VOCs) | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: Aptamer Group Ltd | Commercial: Adx SARS Cp V-2 Virus Antigen Rapid Point of Care Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: BIOTECON Diagnostics GmbH | Commercial: Acu-Corona 2.0/3.0 SARS-CoV-2 Real-time PCR Kits | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Acumen Research Laboratories Pte Ltd | Commercial: Acu-Corona 2.0 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Acumen Research Laboratories Pte Ltd | Commercial: Acu-Corona | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: ACE2 antibody [N1N2], N-term (GTX101395) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Eachy Biopharmaceuticals | Commercial: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Mesa Biotech | Commercial: Accula SARS-CoV-2 test | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: AcouSort | Commercial: AB Blood plasma separation using ultrasound | Method: Other | Target: Other | Format: Other | 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