| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Promis Diagnostics | Commercial: SensDtect RT-qPCR SARS CoV-2 | Device ID: 323 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Quansys Biosciences | Commercial: Human COVID-19 (2-plex) | Device ID: 327 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: QuantuMDx Group Ltd. | Commercial: QPOC Point of Care NAT for SARS-CoV-2 | Device ID: 329 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: QuantuMDx Group Ltd. | Commercial: QuantuMDx NAT for SARS-CoV-2 | Device ID: 328 | 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: QuikPath Pte Ltd. | Commercial: QuikPath Covid-19 POC molecular test | Device ID: 599 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: RainSure Scientific Co. Ltd. | Commercial: RainSure COVID-19 dPCR Detection Kit (lab-based) | Device ID: 333 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Randox Laboratories Ltd. | Commercial: Extended Coronavirus Array | Device ID: 334 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Rapid Bio LLC | Commercial: Rapid test for IgM/IgG antibodies against SARS-COV-2 | Device ID: 601 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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: RetroVirox Inc. | Commercial: SARS-CoV-2 Pseudovirus assay for Neutralizing Antibodies | Device ID: 486 | Method: Immunoassay | Target: Antibody | Format: Lab-based | 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: Schweitzer Biotech Company Ltd. | Commercial: SBC RNP qPCR Kit | Device ID: 799 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Schweitzer Biotech Company Ltd. | Commercial: SBC SARS-CoV-2 Convective PCR Diagnostic Device/Kit | Device ID: 801 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: ScienCell Research Laboratories | Commercial: ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit | Device ID: 746 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Scope Fluidics SA | Commercial: PCR|COV | Device ID: 604 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39501-Recombinant SARS-CoV-2 Nucleocapsid Protein | Device ID: 605 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39502-Recombinant SARS-CoV-2 Spike Protein | Device ID: 606 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39503-Recombinant SARS-CoV-2 Spike (R682S) Protein | Device ID: 607 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39504-Recombinant SARS-CoV-2 Envelope Protein | Device ID: 608 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39505-Recombinant SARS-CoV (2004) Nucleocapsid Protein | Device ID: 609 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39506-Recombinant MERS-CoV Nucleocapsid Protein | Device ID: 610 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39507-Recombinant Influenza A and B Ha Protein | Device ID: 611 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39508R-Sengenics Respiratory Virus Protein Microarray | Device ID: 612 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39509-Sengenics High-throughput, High Multiplex Microtitre Assay | Device ID: 613 | Method: Immunoassay | Target: Antibody, Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: CoviDx | Device ID: 350 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Shandong Shtars Biological Industry Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Real Time Multiplex RT-PCR Kit User Manual | Device ID: 356 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Shanghai Fosun Long March Medical Science Co. Ltd. | Commercial: 2019-Novel Coronavirus (2019 - nCoV) RT-PCR Detection Kit | Device ID: 358 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Shanghai Fosun Long March Medical Science Co. Ltd. | Commercial: Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit | Device ID: 820 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Shanghai Fosun Long March Medical Science Co. Ltd. | Commercial: Fosun COVID-19 RT-PCR Detection Kit | Device ID: 720 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Shanghai GeneoDx Biotechnology Co. Ltd. | Commercial: Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method) | Device ID: 359 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Shanghai Igenetec Diagnostics Co. Ltd. | Commercial: Novel Coronavirus SARS-CoV-2 Nucleic Acid Detection Kit (Isothermal Amplification on Microfluidic Chip) | Device ID: 360 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: 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: 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: 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: Shenzhen Landwind Medical | Commercial: COVID-19 IgG/IgM Rapid Test Device | Device ID: 691 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Sherlock Biosciences | Commercial: Rapid CRISPR-based tests for SARS-CoV-2 and other pathogens | Device ID: 645 | Method: CRISPR | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Sherlock Biosciences | Commercial: Sherlock CRISPR SARS-CoV-2 | Device ID: 372 | Method: CRISPR | Target: Nucleic acid | Format: Lab-based | 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: Sigmed Sp. z o.o. | Commercial: Redtest SARS-CoV-2 Antigen Rapid Test (Covid-19 Ag) | Device ID: 2328 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: SignalDT Biotechnologies (SZ) Inc. | Commercial: LyoDx A Freeze-Dried Real-Time RT-PCR Detection Reagent for SARS-CoV-2 | Device ID: 373 | Method: RT-PCR | Target: Other | Format: 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: 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: 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: SNP Biotechnology R&D Ltd. Co. | Commercial: COVID-19 Real Time PCR Kit | Device ID: 809 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Solis Biodyne | Commercial: SOLIScript 1-step CoV Kit | Device ID: 886 | Method: | Target: | Format: | 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: SPAN BIOTECH Ltd. | Commercial: Covid-19 Antigen Rapid Test Cassette | Device ID: 2787 | Method: Immunoassay | Target: Antigen | Format: Manual, 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