| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Shenzhen Watmind Medical Co. Ltd. | Commercial: SARS-CoV-2 Ag Self-test Kit (Saliva) | Device ID: 3042 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Watmind Medical Co. Ltd. | Commercial: SARS-CoV-2/Influenza A/B/RSV Antigen Rapid Test Kit | Device ID: 24740 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: 2019-nCoV Antigen Control (CGIA) | Device ID: 1705 | Method: Other | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: 2019-nCoV Antigen Control (CLIA) | Device ID: 1703 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: 2019-nCoV Antigen Control (IFA) | Device ID: 1704 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: 2019-nCoV IgG Control | Device ID: 1084 | Method: Immunoassay | Target: Antibody, IgG | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: 2019-nCoV IgM Control | Device ID: 1085 | Method: Immunoassay | Target: Antibody, IgM | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: 2019-nCoV NAb Control (CLIA) | Device ID: 1706 | Method: Other | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: GLINE-2019-nCoV Ag | Device ID: 1347 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: GLINE-2019-nCoV Ag & Influenza A/B Ag Combo Rapid Test (Colloidal Gold Assay) | Device ID: 24753 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: GLINE-2019-nCoV Ag (Self-test) | Device ID: 2891 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: GLINE-2019-nCoV Ag Saliva | Device ID: 1893 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: GLINE-2019-nCoV IgA | Device ID: 1083 | Method: Immunoassay | Target: Antibody, IgA | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: GLINE-2019-nCoV IgM/IgG | Device ID: 1082 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: GLINE-2019-nCoV NAb | Device ID: 1701 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: iFlash-2019-nCoV Antigen | Device ID: 1169 | Method: Immunoassay | Target: Antigen | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: iFlash-2019-nCoV IgA | Device ID: 1081 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: iFlash-2019-nCoV NAb | Device ID: 1477 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: iFlash-SARS-CoV-2 IgG | Device ID: 1079 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: iFlash-SARS-CoV-2 IgG-S | Device ID: 2697 | Method: | Target: Antibody | Format: | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: iFlash-SARS-CoV-2 IgM | Device ID: 1080 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: UNICELL-2019-nCoV Ag | Device ID: 1170 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: UNICELL-2019-nCoV NAb | Device ID: 1478 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Yilifang Biotech Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Colloidal Gold) | Device ID: 2333 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Zhenrui Biotechnology Co. Ltd. | Commercial: Zhenrui ®COVID-19 Antigen Test Cassette | Device ID: 1574 | Method: Immunoassay | Target: Antigen | 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: Yes | Manufacturer: Shijiazhuang Hipro Biotechnology Co. Ltd. | Commercial: Automatic ImmunoAssay System - HP-AFS/1 | Device ID: 1095 | Method: Nephelometry | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shijiazhuang Hipro Biotechnology Co. Ltd. | Commercial: POCT Immunoassay System - HP-083/4 | Device ID: 1094 | Method: Nephelometry | Target: Antigen, IgG | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Shijiazhuang Hipro Biotechnology Co. Ltd. | Commercial: SARS-COV-2 ANTIGEN TEST KIT (COLLOIDAL GOLD) | Device ID: 2546 | Method: Immunoassay | Target: Antigen | Format: Manual | 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: Yes | Manufacturer: Sichuan Xincheng Biological Co. Ltd. | Commercial: SARS-Cov-2 Antigen Assay kit by Immunofluorescence Chromatography method | Device ID: 1659 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sichuan Xincheng Biological Co. Ltd. | Commercial: SARS-Cov-2 Antigen Assay kit by Latex Immunochromatography method | Device ID: 1660 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sichuan Xincheng Biological Co. Ltd. | Commercial: SARS-Cov-2 IgG/IgM Antibody Assay Kit by Immunofluorescence Chromatography Method | Device ID: 616 | Method: Chromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sichuan Xincheng Biological Co. Ltd. | Commercial: SARS-Cov-2 IgG/M Antibody Assay kit by Colloidal Gold Method | Device ID: 1661 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: ADVIA Centaur CP SARS-CoV-2 IgG (sCOVG) | Device ID: 2022 | Method: Immunoassay | Target: Antibody, IgG | Format: Lab-based, Other | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: ADVIA Centaur XP/XPT SARS-CoV-2 Antigen (CoV2Ag) | Device ID: 2016 | Method: Immunoassay | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: ADVIA Centaur XP/XPT SARS-CoV-2 IgG (sCOVG) | Device ID: 2024 | Method: Immunoassay | Target: IgG | Format: Lab-based, Other | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: Atellica IM SARS-CoV-2 Antigen (CoV2Ag) | Device ID: 2015 | Method: Immunoassay | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: Atellica IM SARS-CoV-2 IgG (sCOVG) | Device ID: 2023 | Method: Immunoassay | Target: Antibody, IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: CLINITEST Rapid Covid-19 Antigen Test | Device ID: 1218 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: Dimension Vista SARS-CoV-2 IgG (CV2G) | Device ID: 2025 | Method: Immunoassay | Target: IgG | Format: Lab-based, Other | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: Fast Track Diagnostics (FTD) SARS-CoV-2 Assay | Device ID: 747 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: SARS-CoV-2 Total (COV2T) assay | Device ID: 1049 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Sigmed Sp. z o.o. | Commercial: Redtest Professional Sars-CoV-2 Antigen Rapid Test (Covid-19 Ag) | Device ID: 2256 | 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: Yes | Manufacturer: Silversite diagnostics.corp | Commercial: Antibody kit igg igm testing | Device ID: 1731 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: simin.chen@lifotronic.com | Commercial: Nucleic Acid Extraction Reagent | Device ID: 2614 | Method: | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: SINGUWAY BIOTECH Inc. | Commercial: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Device ID: 1155 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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