| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Lateral Flow Assay) | Device ID: 2166 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Kingfocus Biomedical Engineering Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit(Quantum Dots-Based Immunofluorescence Chromatography) | Device ID: 2941 | Method: Immunochromatography | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Kisshealth Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (GICA) | Device ID: 1813 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lvshiyuan Biotechnology Co. Ltd. | Commercial: Green Spring SARS-CoV-2 Antigen-Rapid test-Set | Device ID: 2109 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lvshiyuan Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Immunofluorescence Assay) | Device ID: 2989 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 2233 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 & Influenza A/B Antigen Combo Test Kit(Colloidal Gold Chromatographic Immunoassay) | Device ID: 5751 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 1967 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Fluorescence Immunoassay) | Device ID: 1968 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 1178 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay) | Device ID: 1228 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen New Industries Biomedical Engineering Co. Ltd. | Commercial: RapiSafe SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) | Device ID: 2978 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Reagent Technology Co. Ltd. | Commercial: SARS-CoV-2 antigen IVD kit SWAB | Device ID: 2026 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO. LTD | Commercial: SARS-CoV-2 Antigen Rapid Self-test Kit (Colloidal Gold) | Device ID: 5738 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Superbio Technology Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) | Device ID: 3999 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Superbio Technology Co. Ltd. | Commercial: 2019-nCOV Antigen Rapid Test | Device ID: 5766 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Superbio Technology Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) | Device ID: 3086 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Superbio Technology Co. Ltd. | Commercial: COVID-19 Ag+Flu A/Flu B Rapid Test (Immunochromatography Assay) | Device ID: 3617 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Superbio Technology Co.,Ltd. | Commercial: COVID-19 Ag+Flu A/Flu B Rapid Test (Immunochromatography Assay) | Device ID: 3270 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Ultra-Diagnostics Biotec. Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 2017 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Uni-medica Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2999 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Watmind Medical Co. Ltd. | Commercial: SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) | Device ID: 1769 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| 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: 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 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: 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: UNICELL-2019-nCoV Ag | Device ID: 1170 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: 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 | Format: Near POC / POC, Semi-automated | 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: 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: SINGUWAY BIOTECH Inc. | Commercial: SINGUWAY COVID-19 Ag Test | Device ID: 1650 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sona Nanotech | Commercial: Sona Nanotech COVID-19 Lateral Flow Assay Lateral flow screening test for S1 domain of SARS-CoV-2 S1 protein | Device ID: 502 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SPAN BIOTECH Ltd. | Commercial: COVID-19 Antigen Rapid Test | Device ID: 2817 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Spark Diagnostics LLC | Commercial: CoV-Check DIRECT Covid-19 Antigen Test | Device ID: 1196 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Spartacus-Biomed | Commercial: COVID-19 Antigen Rapid Test | Device ID: 2185 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sugentech Inc. | Commercial: SGTi-flex COVID-19 Ag | Device ID: 1114 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test (Colloidal Gold) | Device ID: 1273 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co. Ltd. | Commercial: Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay) | Device ID: 1274 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: SARS-CoV-2 Rapid Antigen Test Cassette | Device ID: 2297 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: SureScreen COVID-19 Antigen Rapid Test Cassette | Device ID: 1275 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Surge Medical Inc. | Commercial: COVID-19 Antigen Test Kit | Device ID: 1942 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Surge Medical Inc. | Commercial: COVID-19/Influenza A+ B Antigen Test Kit | Device ID: 1943 | Method: Immunoassay | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Suzhou Soochow University Saier Immuno Biotech Co. Ltd. | Commercial: InstantSure Covid-19 Ag CARD | Device ID: 3015 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Swedicine AB | Commercial: Covid-19 Antigen Rapid Test Cassette | Device ID: 1467 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Synbiotik Biotechnology | Commercial: Q-Check Rapid Lateral Flow Assay for SARS-CoV-2 Antigen Detection | Device ID: 2884 | 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