| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd. | Commercial: 2019- nCoV Antigen Rapid Test | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd. | Commercial: 2019-nCoV Neutralizing Antibody Test Kit (Colloid Gold Immunoassay) | Method: | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Advanced Molecular Diagnostics | Commercial: AMD Human SARS-CoV-2 detection kit | Method: | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: Anti-SARS-CoV-2-NCP ELISA (IgG) | Method: | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical CO., LTD | Commercial: Asan Easy Test COVID-19 Ag | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioeksen R&D Technologies Ltd | Commercial: Bio-Speedy Direct RT-qPCR SARS-CoV-2 | Method: | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co., Ltd | Commercial: COVID-19 Antibody Rapid Test Kit | Method: | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DIAsource ImmunoAssays S.A. | Commercial: COVID-19 Antigen Rapid Test | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co., Ltd. | Commercial: COVID-19 Antigen Rapid Test Cassette (Nasal Swab) | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc | Commercial: COVID-19 Antigen Rapid Test Device | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co., Ltd | Commercial: COVID-19 Antigen Rapid Test Kit(Swab) | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nantong Diagnos Biotechnology Co., Ltd | Commercial: COVID-19 Antigen Saliva Test Kit (Colloidal Gold) | Method: | Target: Antigen | Format: Manual, 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: | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Genmark Saglik Urunleri Ith. Ihr. ve Tic. Ltd Sti. | Commercial: geneMAP Respiratory Viral PCR Panel 2 (2019-nCoV, Inf A/B, RSV A/B) | Method: | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: GLINE-2019-nCoV Ag | Method: | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: GLINE-2019-nCoV Ag Saliva | Method: | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: iFlash-SARS-CoV-2 IgG | Method: | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: AniCon Labor GmbH | Commercial: Kylt SARS-CoV-2 Screening RTU RT-qPCR | Method: | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co., Ltd. | Commercial: Nucleic Acid Extraction or Purification Kit | Method: | Target: | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc | Commercial: PCL COVID19 Ag Gold | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd. | Commercial: Rapid COVID-19 Antigen Test(Colloidal Gold) | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Spindiag GmbH | Commercial: Rhonda Corona test | Method: | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MultiplexDX | Commercial: rTest COVID-19 qPCR ALLPLEX Kit | Method: | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech(Hangzhou) Co. Ltd | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva) | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Method: | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: ELITechGroup S.p.A. | Commercial: SARS-CoV-2 ELITe MGB® Kit | Method: | Target: | Format: Automated, Fully automated (robot), Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co., Ltd. | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) Antigen Assay Kit by Colloidal Gold Method | Method: | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd | Commercial: Wantai SARS-CoV-2 IgM ELISA | Method: | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wizbio Solutions | Commercial: WizDx COVID-9 CrystalMix PCR Kit | Method: | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: biocomma limited | Commercial: biocomma®COVID-19 Antigen Test Kit | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PZ CORMAY S.A. | Commercial: Cormay Rapid SARS-CoV-2 IgG/IgM Ab | Method: Chromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co., Ltd | Commercial: COVID-19 Antigen Detection Kit | Method: Chromatography | Target: Antigen | Format: Near POC / POC | 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: MEXACARE GmbH | Commercial: MEXACARE COVID-19 Antigen Rapid Test | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nal von minden GmbH | Commercial: NADAL COVID-19 Ag Test | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co., Ltd | Commercial: SARS-CoV-2 Antigen Rapid Test | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sichuan Xincheng Biological Co., LTD | Commercial: SARS-Cov-2 IgG/IgM Antibody Assay Kit by Immunofluorescence Chromatography Method | Method: Chromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Nano Diagnosis of Health Biotechnology Co., Limited | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette ( Colloidal Gold Method) | Method: Chromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DIASORIN S.P.A. | Commercial: LIAISON® SARS-CoV-2 Ag (311490) | Method: CLIA | Target: Antigen | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co., Ltd | Commercial: MAGLUMI SARS-CoV-2 Neutralizing Antibody (CLIA) | Method: CLIA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co., Ltd | Commercial: MAGLUMI SARS-CoV-2 S-RBD IgG (CLIA) | Method: CLIA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. | Commercial: SARS-CoV-2 IgG (CLIA) | Method: CLIA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. | Commercial: SARS-CoV-2 IgM (CLIA) | Method: CLIA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. | Commercial: SARS-CoV-2 NAbs (CLIA) | 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 IgG (CLIA) | Method: CLIA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd | Commercial: 2019-nCOV IgG Antibody kit (ELISA) | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd | Commercial: 2019-nCOV IgM Antibody kit (ELISA) | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diagnostic Automation/Cortez Diagnostics, Inc | Commercial: Accudiag SCoV-2 IgG ELISA | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diagnostic Automation/Cortez Diagnostics, Inc | Commercial: Accudiag SCoV-2 IgM ELISA Kit | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: Anti-SARS-CoV-2 ELISA (IgA) | Method: ELISA | Target: Antibody, IgA | Format: Automated, Manual | 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