| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: UPMC | Commercial: COVID-19 test | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Willi Fox GmbH | Commercial: COVID-19 Test IgM/ IgG | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Camtech Biomedical PTE, LTD; Obelis S.A. (BE) | Commercial: COVID-19 Viral Antigen Test Kit | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Abace Biology Co., Ltd | Commercial: COVID-19 Viral Antigen Test Kit (Colloidal Gold Immunochromatography) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Abace Biology Co., Ltd | Commercial: COVID-19 Viral Antigen Test Kit (ELISA) | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vircell S.L. | Commercial: COVID-19 VIRCLIA IgG MONOTEST | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vircell S.L. | Commercial: COVID-19 VIRCLIA IgM+IgA MONOTEST | Method: Immunoassay | Target: Antibody, IgM, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mabsky Bio-Tech Co., Ltd | Commercial: COVID-19 virus (2019-nCoV) Dual-Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mabsky Bio-Tech Co., Ltd | Commercial: COVID-19 virus (2019-nCOV) Triple-Detection Kit (Real-Time PCR Method) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: VEDALAB | Commercial: COVID-19-CHECK-1 test | Method: Chromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc | Commercial: COVID-19/Flu A/B Antigen Combo Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AmonMed Biotechnology Co., Ltd | Commercial: COVID-19/Influenza A virus/Influenza B virus test kit (Rare Earth Nano Fluorescence Immunochromatography) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vazyme | Commercial: COVID-19/Influenza A virus/Influenza B virus test kit (Rare Earth Nano Fluorescence Immunochromatography) | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co., Ltd | Commercial: COVID-19/Influenza A+B Antigen Combo Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DIAsource ImmunoAssays | Commercial: COVID-19 IgG ELISA KAPCOVID19G | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: JOYSBIO (Tianjin) Biotechnology Co., Ltd | Commercial: COVID-9 IgG/IgM Rapid Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COVID-PRESTO | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COVID-VIRO | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: COVID19 Antigen Rapid Test Kit | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Pharmatech | Commercial: COVID19 IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Novus Biologicals LLC, Bio-techne brand | Commercial: COVID19 IgG/IgM Rapid Test Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Norgen Biotek Corp. | Commercial: COVID19 TaqMan RT-PCR Kit Dx (E-RdRP genes) (DxTM67200) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: D-tek s.a. | Commercial: COVID5GDIV-24 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: CovidAg | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd | Commercial: COVIDscreen Plus ELISA Kit | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd | Commercial: COVIDsure Multiplex Realtime RT-PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd | Commercial: COVIDsure Pro Multiplex RT PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co., Ltd | Commercial: COVIDTECH One Step SARS-CoV-2 IgM/IgG Antibody Rapid Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Eternal Materials Co., Ltd | Commercial: COVIDual COVID-19 IgM/IgG Rapid Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd | Commercial: CoviDx | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zephyr Biomedicals-Tulip Group | Commercial: COVISCREEN test for detection of IgM/IgG/IgA antibodies | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: LINEAR CHEMICALS, S.L.U. | Commercial: Cromatest COVID-19 Antigen Cassette | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Oncosem Onkolojik Sistemler San. ve Tic. A.S. | Commercial: CRT (COVID 19 RAPID TEST) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Curative Inc (in conjunction with KorvaLabs, Inc) | Commercial: Curative-Korva SARS-Cov-2 Assay | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Dablood pharmaceutical | Commercial: DABLOOD COVID-19 IgM/IgG Rapid Antibody Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ALLUM SRL | Commercial: DAILY TAMPON | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: DART Diagnostics | Commercial: DART COVID-19 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Appolon Bioteck | Commercial: Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Anlong Gene Technology Co., Ltd | Commercial: Detection Kit for 2019-nCov nucleic acid (Fluorescence PCR) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Guangdong Huayin Medicine Science Co.,. Ltd | Commercial: Detection Kit for 2019-nCoV RNA (RT-PCR Fluorescence Probing) (Lyophilised) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genetron | Commercial: Detection Kit for Novel Coronavirus (SARS-CoV-2) RNA (PCR-Fluorescence Probing) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: EMG | Commercial: Detection Kit for the SARS-CoV-2 RNA Presence in Biological Material Using Real-Time (RUO) | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Microdiag Biomedicine Technology Co., Ltd | Commercial: Detection of 2019 novel coronavirus (2019-nCoV) by LFD RT-RAA | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Diagen Biotechnologic Systems Inc | Commercial: Dia-CV19-1 SARS-CoV-2 OneStep RT-PCR Kit (S-Gene) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diagen Biotechnologic Systems Inc | Commercial: Dia-CV19-2 SARS-CoV-2 OneStep RT-PCR Kit (S-/ORF1ab-Gene) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diagen Biotechnologic Systems Inc | Commercial: Dia-CV19-3 SARS-CoV-2 Direct OneStep RT-PCR Kit (S-/ORF1ab-Gene) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Next Pharma Inc | Commercial: DiaCarta's QuantiVirusTMSARS-CoV-2 Test | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diagnostics Automation | Commercial: Diagnostic Automation, Inc. SARS-CoV-2 RT-PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genesprint Group Limited | Commercial: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV- 2 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Novatech Tıbbi Cihaz Ürünleri Sanayi ve Ticaret A.Ş. | Commercial: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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