| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: Shanghai Conlight Medical Lab Co., Ltd. | Commercial: SARS-CoV-2/FluA/FluB/RSV detection kit（PCR MALDI-TOF-MS） | Device ID: 1821 | Method: Other | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Vircell, s.l. | Commercial: SARS-CoV-2/FLU/RSV REALTIME PCR KIT | Device ID: 2083 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd | Commercial: SARS-CoV-2/ Flu A/ Flu Ag FIA Test | Device ID: 2120 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vector-Best | Commercial: SARS-CoV-2-IgM-EIA-BEST | Device ID: 1464 | Method: Immunoassay | Target: Antibody, IgM | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Vector-Best | Commercial: SARS-CoV-2-IgG-EIA-BEST | Device ID: 1463 | Method: Immunoassay | Target: Antibody, IgG | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Sansure Biotech Inc. | Commercial: SARS-CoV-2-Antigen-Schnelltest (Immunochromatographie) | Device ID: 2366 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: Hangzhou Realy Tech Co., Ltd | Commercial: SARS-Cov-2&Influenza A&B Combo Rapid Test Cassette (swab) | Device ID: 1789 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd | Commercial: SARS-CoV-2&Flu A& Flu B Ag Rapid Test | Device ID: 2119 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vircell, s.l. | Commercial: SARS-COV-2 VARIANTS REALTIME PCR KIT | Device ID: 2084 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Foregene Co., Ltd | Commercial: SARS-CoV-2 Variant Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method) | Device ID: 2071 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Canary Global Inc | Commercial: SARS-CoV-2 Ultra Rapid Mobile Antigen Test | Device ID: 2547 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Astra Biotech GmbH | Commercial: SARS-CoV-2 Triplex PCR kit | Device ID: 1132 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD. | Commercial: SARS-CoV-2 Total Antibody Test Kit (ELISA) | Device ID: 2337 | Method: ELISA | Target: Antibody | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD. | Commercial: SARS-CoV-2 Total Antibody Rapid Test Kit | Device ID: 2339 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | 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: 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: DIALAB GmbH | Commercial: SARS-CoV-2 Total Ab | Device ID: 1050 | Method: ELISA | Target: Antibody | Format: Lab-based | 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: Xiamen Zeesan Biotech Co., Ltd | Commercial: SARS-CoV-2 Test Kit | Device ID: 441 | Method: RT-PCR | Target: Nucleic acid | 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 Microprofit Biotech Co., Ltd | Commercial: SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 1178 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: 2501 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2400 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd. | Commercial: SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2404 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2395 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd. | Commercial: SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2403 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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: Hangzhou AllTest Biotech Co., Ltd | Commercial: SARS-COV-2 RT-qPCR Assay | Device ID: 1368 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: SARS-COV-2 RT-qPCR Assay | Device ID: 1388 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: Vitro SA | Commercial: SARS-CoV-2 RT-PCR | Device ID: 630 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: bioMérieux SA | Commercial: SARS-COV-2 RESPI R-GENE | Device ID: 2004 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vircell S.L. | Commercial: SARS-COV-2 REALTIME PCR KIT | Device ID: 426 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: ViennaLab Diagnostics GmbH | Commercial: SARS-CoV-2 RealFast™ Assay | Device ID: 2530 | Method: RT-PCR | Target: | Format: Automated, Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Sacace BIOTECNOLOGIES | Commercial: SARS-CoV-2 Real-TM | Device ID: 487 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Goldsite Diagnostics Inc | Commercial: SARS-CoV-2 Real-time RT-PCR Kit | Device ID: 1666 | Method: RT-PCR | Target: Nucleic acid | Format: 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: BIOMAXIMA S.A. | Commercial: SARS-CoV-2 Real Time PCR LAB-KIT | Device ID: 89 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: RTA | Commercial: SARS-CoV-2 Real Time PCR Kits | Device ID: 974 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Nuclear Laser Medicine srl | Commercial: SArs-CoV-2 Real Time | Device ID: 2296 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pharmact (Berlin) | Commercial: SARS-COV-2 Rapid Test | Device ID: 501 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pharmact (Berlin) | Commercial: SARS-CoV-2 Rapid TesIgM/IgG | Device ID: 485 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Medomics Medical Technologies | Commercial: SARS-CoV-2 rapid combined IgM/IgG antibody test kit | Device ID: 500 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Roche (SD BIOSENSOR) | Commercial: SARS-CoV-2 Rapid Antigen Test Nasal | Device ID: 2228 | Method: Immunochromatography | 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: Hangzhou AllTest Biotech Co., Ltd | Commercial: SARS-COV-2 rapid antigen test (Swab) | Device ID: 1946 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sansure Biotech Inc. | Commercial: SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) | Device ID: 2097 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Roche (SD BIOSENSOR) | Commercial: SARS-CoV-2 Rapid Antigen Test | Device ID: 1604 | Method: Immunoassay | Target: Antigen | 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