| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: RayBiotech | Commercial: Coronavirus (SARS-CoV-2) IgM/IgG Test Kit (Colloidal Gold) | Device ID: 337 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ring Biotechnology Co. Ltd. | Commercial: COVID-19 IgM/IgG Rapid Test Kit | Device ID: 603 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ROCHE Diagnostics | Commercial: Elecsys® Anti-SARS-CoV-2 | Device ID: 882 | Method: Immunoassay | Target: Antibody | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: ROCHE Diagnostics | Commercial: Elecsys® Anti-SARS-CoV-2 S | Device ID: 2160 | Method: Immunoassay | Target: Antibody | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Safecare Biotech (Hangzhou) Co. Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test Device (Whole Blood/Plasma/Serum) | Device ID: 1035 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Safecare Biotech (Hangzhou) Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Rapid Test Kit( Whole blood/Serum/Plasma) | Device ID: 2199 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Salofa Oy | Commercial: Salocor COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 1047 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Salofa Oy | Commercial: Sienna COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 1039 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ScheBo Biotech | Commercial: ScheBo SARS-CoV-2 Quick | Device ID: 798 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SCREEN ITALIA S.r.l. | Commercial: Screen Test Covid-19 - 2019-NCoV IgG/IgM Rapid Test Cassette | Device ID: 992 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc. | Commercial: STANDARD Q COVID-19 IgM/IgG Duo Test | Device ID: 346 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Secutronic Technology Co. Ltd. | Commercial: SETRO | Device ID: 1152 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sensing Self Pte. Ltd. | Commercial: COVID-19 Rapid IgG/IgM Combined Antigen Assay Pre-screening Test Kit (Model ERCSS05401) | Device ID: 870 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sensing Self Pte. Ltd. | Commercial: EDR COVID 19 Rapid Test Kit (IgM/IgG) | Device ID: 351 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sensing Self Pte. Ltd. | Commercial: Novel Coronavirus Neutralizing Antibody Rapid Test Kit | Device ID: 2040 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: servoprax GmbH | Commercial: Cleartest Corona, Covid-19 | Device ID: 354 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics COVID-19 Immunity Strength Rapid Test Kit (RBD Neutralizing Antibody) | Device ID: 2028 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shandong ThinkLab Biotechnology Co. Ltd. | Commercial: 09-nCOV IgM/IgG antibody test kits (Colloidal-gold Assay) | Device ID: 945 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai B&C Biological Technology | Commercial: SARTS-CoV2 IgM/IgG antibody test | Device ID: 1015 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai BioGerm Medical Technology Co. Ltd. | Commercial: Diagnostic Kit for 2019-nCoV IgM/IgG Antibody (Colloidal Gold) | Device ID: 2178 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19 (SARS-CoV-2) IgM/IgG Antibody Rapid Test Kit (Colloidal Gold) | Device ID: 2312 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® Novel Coronavirus(2019-nCoV) IgG Antibody Diagnostic Kit (Colloidal Gold) | Device ID: 2516 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® Novel Coronavirus(2019-nCoV) IgM Antibody Diagnostic Kit （Colloidal Gold) | Device ID: 357 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Diagnostic Kit (Colloidal Gold) | Device ID: 2311 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: nCoV IgG/IgM combo test | Device ID: 1023 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai International Holding Corp. GmbH(Europe) (DE) | Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 987 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Kehua Bio-engineering Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG Antibody (Colloidal Gold) | Device ID: 871 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Outdo Biotech Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test (Colloidal Gold) | Device ID: 614 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Detection Kit(Fluorescence Immunoassay) | Device ID: 2621 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Detection Kit (Colloidal Gold) | Device ID: 2558 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Dakewe Bio-engineering Co. Ltd. | Commercial: COVID-19 IgM/IgG Rapid Test Kit | Device ID: 1998 | Method: Immunochromatography | Target: Antibody | 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 | 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 | Format: Automated, 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 | Format: Near POC / POC | 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 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 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: SARS-CoV-2 IgG & IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 808 | Method: Immunoassay | Target: Antibody | 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 | 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 Mindray Bio-Medical Electronics Co. Ltd. | Commercial: SARS-CoV-2 IgG assay | Device ID: 1076 | Method: Immunoassay | Target: Antibody | 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 | 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 | Format: Automated, Manual | 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 | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: 2019-nCoV IgG Control | Device ID: 1084 | Method: Immunoassay | Target: Antibody | 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 | 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 IgA | Device ID: 1083 | Method: Immunoassay | 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