| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: BioProbes Srl COV19G.CE - ELISA COVID 19 IgG | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: BioProbes Srl COV19M.CE - ELISA COVID 19 IgM | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: BIOSYNEX S.A. | Commercial: BIOSYNEX AMPLIQUICK Respiratory Triplex | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: BIOSYNEX S.A. | Commercial: BIOSYNEX AMPLIQUICK SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: BIOSYNEX SWISS SA | Commercial: BIOSYNEX COVID-19 Ag BSS | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOSYNEX SWISS SA | Commercial: BIOSYNEX COVID-19 Ag+ BSS | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOSYNEX SWISS SA | Commercial: BIOSYNEX COVID-19 BSS | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Inzek international trading bv | Commercial: Biozek covid-19 Antigen Rapidtest BCOV-502 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anatolia Geneworks | Commercial: Bosphore Novel Coronavirus (2019-nCoV) Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Biotrack B.V. | Commercial: BTMED | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Camtech Diagnostics Pte Ltd | Commercial: Camtech COVID-19 Rapid Test Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wells Bio, Inc | Commercial: careGENE COVID-19 RT-PCR kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wells Bio, Inc | Commercial: careGENE N-CoV RT-PCR kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Yes | Manufacturer: Access Bio, Inc | Commercial: CareStart COVID-19 MDx RT-PCR | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Yes | Manufacturer: Oncosem Onkolojik Sistemler San. ve Tic. A.S. | Commercial: CAT | Method: Immunoassay | Target: Antigen | 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) | 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: Yes | Manufacturer: Cellex Inc | Commercial: Cellex qSARS-CoV-2 IgGIgM Cassette Rapid Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CerTest Biotec, S.L. | Commercial: CerTest SARS-CoV-2 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: CerTest Biotec, S.L. | Commercial: CerTest SARS-CoV-2 Card test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: B-bio Co., Ltd. | Commercial: ChekR™ COVID-19 IgM/IgG Rapid test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NB POSTECH | Commercial: Chexel COVID-19 IgM/IgG | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chil Tibbi Mal. San. Tic. Ltd Sti. | Commercial: CHIL COVID-19 Antigen Rapid Test (Nasopharyngeal / Oropharyngeal Swab-Casette) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chil Tibbi Mal. San. Tic. Ltd Sti. | Commercial: CHiL COVID-19 IgG/IgM Rapid Test cassette | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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: 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: CirrusDx Laboratories | Commercial: CirrusDx SARS-CoV-2 Assay | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Genomica Sau | Commercial: CLART COVID-19 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Yes | Manufacturer: servoprax GmbH | Commercial: Cleartest Corona, Covid-19 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: CLINITEST Rapid Covid-19 Antigen Test | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: Yes | Manufacturer: Hangzhou Clongene Biotech Co., Ltd | Commercial: Clungene COVID-19 IgM/IgG Rapid Test Cassette | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ROCHE Diagnostics | Commercial: cobas SARS-CoV-2 (for use on the cobas 6800/8800 Systems) | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: Anhui Deep Blue Medical Technology Co., Ltd | Commercial: Colloidal gold strip for SARS-CoV-2 IgG & IgM | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biotech & Biomedicine (Shenyang) Group Ltd | Commercial: Colorimetric and Isothermal Detection Kit for COVID-19 Coronavirus | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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 | 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: Applied Biomedical, LLC | Commercial: Confidence COVID-19 Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Convergent Technologies | Commercial: Convergys POC RT-PCR COVID-19 Detectin Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: fameditec GmbH | Commercial: CORA CHECK-19 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: fameditec GmbH | Commercial: CORA-CHECK-19-comfort | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Core Technology Co.,Ltd | Commercial: Coretests COVID-19 Ag Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Core Technology Co.,Ltd. | Commercial: Coretests COVID-19 Ag Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Core Technology Co.,Ltd | Commercial: Coretests COVID-19 Neutralizing Ab Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PZ CORMAY S.A. | Commercial: CORMAY RAPID SARS-CoV-2 ANTIGEN TEST KIT | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PZ CORMAY S.A. | Commercial: Cormay Rapid SARS-CoV-2 IgG/IgM Ab | Method: Chromatography | 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