| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Laipac Technology Inc. | Commercial: LooK SPOT 2 | Device ID: 2368 | Method: Immunoassay | Target: Antigen | Format: Automated, Other | Go to details |
| CE Marking: Yes | Manufacturer: Laipac Technology Inc. | Commercial: LooK SPOT | Device ID: 1667 | Method: Immunoassay | Target: Antigen | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Lomina Superbio a.s. | Commercial: LOMINA SARS-CoV-2 N-Protein Antigen Rapid Test | Device ID: 2158 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Zonka Biotech Co., Ltd | Commercial: LollyTest 2019-nCoV IgG&IgM Antibody Rapid Test Kit | Device ID: 2474 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Zonka Biotech Co., Ltd | Commercial: LollyTest 2019-nCoV Ag Rapid Test Kit | Device ID: 2473 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Zonka Biotech Co., Ltd | Commercial: LollyTest 2019-CoV Ag Saliva Rapid Test Card | Device ID: 2470 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Co-diagnostics | Commercial: Logix Smart Coronavirus disease 2019 (COVID-19) | Device ID: 130 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Livzon Diagnostics Inc | Commercial: Livzon Test for SARS-CoV-2 Antigen (Fluorescence Immunochromatographic Assay) | Device ID: 1442 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Livzon Diagnostics Inc | Commercial: Livzon Rapid Test for SARS-CoV-2 Antigen (Lateral Flow) | Device ID: 1441 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Liangrun Biomedicine Technology Co., Ltd. | Commercial: LionRun™️SARS-CoV-2 Antigen Rapid Test Kit (Lateral Flow Immunoassay) | Device ID: 1863 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Liangrun Biomedicine Technology Co.,Ltd. | Commercial: LionRunTM SARS-CoV-2 Antigen Rapid Test (Lateral Flow Immunoassay) | Device ID: 2155 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: intron biotechnology | Commercial: LiliF GBN Covid-19 Ag Rapid kit | Device ID: 2069 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: iNtRON Biotechnology Inc | Commercial: LiliF COVID-19 Real-time RT-PCR Kit | Device ID: 480 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Redcliffebio | Commercial: LightPower iVASARS-CoV-2 1st RT-rPCR Kit | Device ID: 824 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Liferiver | Commercial: Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCRT kit | Device ID: 260 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: DiaSorin S.p.A | Commercial: LIAISON® SARS-CoV-2 TrimericS IgG (Ref.311510) | Device ID: 1900 | Method: Immunoassay | Target: IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: DiaSorin S.p.A | Commercial: LIAISON® SARS-CoV-2 Ag | Device ID: 1960 | Method: CLIA | Target: Antigen | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Rapid Pathogen Screening, Inc. | Commercial: LIAISON® Quick Detect Covid Ag Assay | Device ID: 2290 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DiaSorin S.p.A | Commercial: LIAISON SARS-CoV-2 S1/S2 IgG | Device ID: 911 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Spartacus-Biomed | Commercial: LFA COVID-19 IgG & IgM Rapid Test Device | Device ID: 2186 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pharmaline AS | Commercial: LAMPIGEN COVID19 RT-LAMP PCR KIT | Device ID: 1825 | Method: LAMP | Target: Nucleic acid | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Labgenomics Co.Ltd | Commercial: LabGun COVID-19 RT-PCR Kit | Device ID: 2352 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Labgenomics Co.Ltd | Commercial: LabGun COVID-19 ExoFast RT-PCR Kit | Device ID: 2351 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Labgenomics Co.Ltd | Commercial: LabGun COVID-19 Assay plus | Device ID: 2353 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Labgenomics Co.Ltd | Commercial: LabGun COVID-19 Assay | Device ID: 2354 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BMT Diagnostics | Commercial: Lab-On-Time COVID-19 Antigen Rapid Test Device (Integrated Throat Swab) | Device ID: 1605 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BMT Diagnostics | Commercial: Lab-On-Time 2019-nCoV IgG/IgM Rapid Test | Device ID: 1168 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AniCon Labor GmbH | Commercial: Kylt SARS-CoV-2 Screening RTU RT-qPCR | Device ID: 512 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AniCon Labor GmbH | Commercial: Kylt SARS-CoV-2 Confirmation RT-Qpcr | Device ID: 511 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Quark Biotechnology Co., Ltd | Commercial: Kwork Covid-19 Ag Rapid Test Device(Saliva/Sputum/Feces) | Device ID: 1322 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AVALUN SAS | Commercial: Ksmart® SARS-COV2 Antigen Rapid Test | Device ID: 1800 | Method: Immunochromatography | Target: Antigen | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Krosgen Biotech | Commercial: KrosQuanT SARS-COV- 2 (2019 nCOV) Realtime PCR Kit | Device ID: 576 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Vatic Health Ltd. | Commercial: KnowNow SARS-CoV-2 Rapid Antigen Test | Device ID: 2508 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: KNAX Ltd. | Commercial: KNAX-SMART SARS-CoV2 Influenza A&B Ag combo | Device ID: 2536 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: KNAX Ltd. | Commercial: KNAX-SMART SARS-CoV-2 IgM/IgG | Device ID: 2537 | Method: Immunoassay | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: KNAX Ltd. | Commercial: KNAX-SMART SARS-CoV-2 Ag | Device ID: 2535 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NATRIX S.R.L. | Commercial: KIT REVOLUTION COVID-19 RAPID SALIVARY TEST FOR SARS-COV-2 | Device ID: 2349 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NATRIX S.R.L. | Commercial: KIT REVOLUTION COVID-19 ANTIGENIC TEST FOR SARS-COV-2 | Device ID: 2348 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: gerbion GmbH & Co., | Commercial: KG virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0 | Device ID: 567 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 total antibody rapid test | Device ID: 1112 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 total antibody ELISA Test Kit | Device ID: 1111 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 RT-PCR Test Kit | Device ID: 832 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 IgM antibody ELISA Test Kit | Device ID: 67 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 IgG/IgM antibody Rapid Test Kit (Colloidal Gold) | Device ID: 71 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 IgG antibody ELISA Test Kit | Device ID: 69 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence) | Device ID: 1285 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 Antigen Rapid Test Kit (FIA) | Device ID: 70 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 1284 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: OPTOLANE Technologies, Inc. | Commercial: Kaira 2019-nCoV Detection kit | Device ID: 794 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou GENESIS Biodetection and Biocontrol CO.,LTD | Commercial: KaiBiLi COVID-19 Antigen | Device ID: 2085 | Method: Immunochromatography | 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