| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Mokobio Biotechnology R&D Center | Commercial: SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay | Device ID: 285 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. | Commercial: SARS-CoV-2 IgM (CLIA) | Device ID: 1710 | Method: CLIA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pishtaz Teb Diagnostics | Commercial: SARS-CoV-2 IgM ELISA Kit | Device ID: 597 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ideal Tashkhis Atieh Co. | Commercial: SARS-CoV-2 IgM ELISA Kit | Device ID: 659 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | 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, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. | Commercial: SARS-CoV-2 NAbs (CLIA) | Device ID: 1708 | Method: CLIA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: HANGZHOU BIOER TECHNOLOGY CO., Ltd | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence RT-PCR) | Device ID: 1287 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co., Ltd | Commercial: SARS-CoV-2 Real-Time RT-PCR Assay | Device ID: 1131 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc | Commercial: SARS-COV-2 RT-qPCR Assay | Device ID: 1693 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: UAB Imunodiagnostika | Commercial: SARS-CoV-2 S IgG ELISA | Device ID: 1740 | Method: ELISA | Target: IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd | Commercial: SARS-CoV-2 Total Ab ELISA | Device ID: 833 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Immy | Commercial: SARS-CoV-2 Total Antibody EIA | Device ID: 660 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: LOMINA AG | Commercial: SARS-CoV-2(COVID19)IgM/IgG Antibody Fast Detection Kit | Device ID: 265 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tezted | Commercial: SARSPLEX: Anti-SARS-CoV-2 IgM / IgG / IgA ELISA (measure individual Ig easily) | Device ID: 874 | Method: ELISA | Target: Antibody, IgG, IgM, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: ScheBo Biotech AG | Commercial: ScheBo SARS-CoV-2 Quick | Device ID: 798 | 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, 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: Sugentech, Inc | Commercial: SGT anti-SARS-CoV-2 total Ab ELISA | Device ID: 1113 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Cell ID Pte Ltd | Commercial: Smart COVID-19 IgM/IgG RDT | Device ID: 838 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 NP IgA | Device ID: 1103 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 NP IgG | Device ID: 1104 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 NP IgM | Device ID: 1105 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 RBD IgA | Device ID: 1148 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 RBD IgG | Device ID: 1149 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 RBD IgM | Device ID: 1150 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | 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: Eset Ltd | Commercial: vDetect COVID-19 RT-qPCR diagnostic kit | Device ID: 956 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MultiplexDX | Commercial: vDetect COVID-19 RT-qPCR diagnostic kit | Device ID: 1077 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: bioMérieux SA | Commercial: VIDAS SARS-COV-2 IgG | Device ID: 881 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: bioMérieux SA | Commercial: VIDAS SARS-COV-2 IgM | Device ID: 957 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: VIROTECH Diagnostics GmbH | Commercial: VIROTECH SARS-CoV-2 IgA ELISA | Device ID: 1166 | Method: ELISA | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: VIROTECH Diagnostics GmbH | Commercial: VIROTECH SARS-CoV-2 IgG ELISA | Device ID: 1164 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: VIROTECH Diagnostics GmbH | Commercial: VIROTECH SARS-CoV-2 IgM ELISA | Device ID: 1165 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ortho Clinical Diagnostics | Commercial: VITROS Immunodiagnostic Products SARS-CoV-2 Antigen | Device ID: 1200 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd | Commercial: Wantai SARS-CoV-2 IgM ELISA | Device ID: 834 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Artron Laboratories Inc | Commercial: Artron COVID-19 IgM/IgG Antibody Test | Device ID: 1729 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: AFIAS COVID-19/Flu Ag Combo | Device ID: 1449 | Method: Immunochromatography | Target: Antigen | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: OACP IE LTD | Commercial: Corona Virus Disease 2019 (COVID-19) Nucleic Acid Detection Kit | Device ID: 2442 | Method: RT-PCR | Target: | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: Molaccu COVID-19 Detection Kit | Device ID: 2219 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: OACP IE LTD | Commercial: Novel Coronavirus 2019-nCOV Nucleic Acid Typing Test Kit (Real-Time PCR Method) | Device ID: 2443 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: AB ANALITICA | Commercial: REALQUALITY RQ-2019-nCoV | Device ID: 2093 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: AB ANALITICA | Commercial: REALQUALITY RQ-SARS-CoV-2 | Device ID: 2091 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: Zybio SARS-CoV-2 Assay Kit | Device ID: 2218 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: AFIAS COVID-19 nAb | Device ID: 2399 | Method: Immunoassay | Target: Antibody | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: STAB VIDA | Commercial: Dr Vida pocket for COVID-19 | Device ID: 1993 | Method: LAMP | Target: Nucleic acid | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qlife Aps | Commercial: Egoo System | Device ID: 2263 | Method: Other | Target: | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ArcDia International Oy Ltd | Commercial: mariPOC Quick Flu+ | Device ID: 2079 | Method: Immunoassay | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ArcDia International Oy Ltd | Commercial: mariPOC Respi+ | Device ID: 2078 | Method: Immunoassay | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Watmind Medical Co., Ltd | Commercial: SARS-CoV-2 Ag Diagnostic Test Kit (Immuno-fluorescence) | Device ID: 1768 | Method: Immunochromatography | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Autobio Diagnostics Co., Ltd | Commercial: SARS-CoV-2 IgG II CLIA Microparticles | Device ID: 919 | Method: CLIA | Target: Antibody, IgG | Format: Automated, 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