| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Shenzhen Dymind Biotechnology Co. Ltd. | Commercial: Sars-CoV-2 antigen test kit (colloidal gold) | Device ID: 2415 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Dymind Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 antigen test kit (Saliva sample) | Device ID: 2418 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Dymind Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG Duo Test (Colloidal Gold) | Device ID: 1161 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Everbest Machinery lndustry Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test | Device ID: 3125 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen GeneBioHealth Co. Ltd. | Commercial: SARS-CoV- IgM IgG Test Kit (Colloidal Gold) | Device ID: 946 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen GeneBioHealth Co. Ltd. | Commercial: SARS-CoV- Nucleic Acid Test Kit (RT-PCR) | Device ID: 947 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Highcreation Technology Co. Ltd. | Commercial: Novel Corona- virus IgM/IgG Combo Rapid Test | Device ID: 1345 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Huaree Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) | Device ID: 2812 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Huian Biosci Technology Co. Ltd. | Commercial: Rapid nCoV & Flu A/B Ag Test Kit (Colloidal Gold) | Device ID: 4098 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Huian Biosci Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 3356 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Huian Biosci Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2414 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| 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, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Kisshealth Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antibodies Test Kit (Latex particle-enhanced turbidimetric immunoassay) | Device ID: 1817 | Method: Immunoassay | Target: Antibody | Format: 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 Kisshealth Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibodies Test Kit (Latex particle-enhanced turbidimetric immunoassay) | Device ID: 1816 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Kisshealth Biotechnology Co. Ltd. | Commercial: SARS-CoV-2/Human Influenza Virus A&B（Flu A&B）Antigen Test Kit(Colloidal Gold) | Device ID: 1814 | Method: Immunochromatography | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lifotronic Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen (GICA) | Device ID: 2148 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lifotronic Technology Co. Ltd. | Commercial: SARS-CoV-2 IgG (Electrochemiluminescence Immunoassay) | Device ID: 2753 | Method: CLIA | Target: IgG | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lifotronic Technology Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Freeze-Dried) | Device ID: 2086 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lifotronic Technology Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Gene Mutation) | Device ID: 2087 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lifotronic Technology Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method) | Device ID: 2613 | Method: RT-PCR | Target: | Format: Manual | 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: fluorecare SARS-CoV-2 Antibody Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 2181 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: fluorecare SARS-CoV-2 Antibody Test Kit (Fluorescence Immunoassay) | Device ID: 2182 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: fluorecare SARS-CoV-2 Neutralizing Antibody Test Kit (Fluorescence Immunoassay) | Device ID: 2168 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: Respiratory 13 Pathogen Antigen Test Kit(Colloidal Gold Chromatographic Immunoassay) | Device ID: 25672 | 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 & 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 (Colloidal Gold Chromatographic Immunoassay) （Saliva） | Device ID: 2606 | 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 IgG & IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 808 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Fluorescence Immunoassay) | Device ID: 1227 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 2620 | Method: Immunochromatography | Target: Antibody | 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 Mindray Bio-Medical Electronics Co. Ltd. | Commercial: SARS-CoV-2 IgG assay | Device ID: 1076 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co. Ltd. | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2 IgG (CLIA) | Device ID: 1071 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co. Ltd. | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2 IgM (CLIA) | Device ID: 1072 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen New Industries Biomedical Engineering Co. Ltd. | Commercial: MAGLUMI SARS-CoV-2 Ag (CLIA) | Device ID: 2187 | Method: CLIA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen New Industries Biomedical Engineering Co. Ltd. | Commercial: Molecision SARS-CoV-2, Flu & RSV RT-PCR Assay | Device ID: 2188 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | 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 Poweray Biotechnology Co. Ltd. | Commercial: miki-lu | Device ID: 2674 | Method: Other | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Reagent Technology Co. Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test Kit | Device ID: 651 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Reagent Technology Co. Ltd. | Commercial: SARS-CoV-2 antigen IVD kit NASAL | Device ID: 3029 | 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 SALIVA | Device ID: 2295 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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 |
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