| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: 3D Biomedicine Science & Technology Co., Limited | Commercial: 96A Viral RNA Auto Extraction & Purification Kit | Device ID: 2254 | Method: | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co.,Ltd | Commercial: ACCU-TELL® SARS-CoV-2 Neutralizing Antibody Cassette | Device ID: 2581 | Method: | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Avacta Life Sciences Ltd | Commercial: AffiDX SARS-CoV-2 Antigen Lateral Flow Test | Device ID: 2426 | Method: | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: 3D Biomedicine Science & Technology Co., Limited | Commercial: ANDiS Viral RNA Auto Extraction & Purification Kit | Device ID: 2253 | Method: | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. | Commercial: COVID-19 & Influenza A/B Antigen Nasal Test Kit | Device ID: 2280 | Method: | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Beier Bioengineering Co.,Ltd | Commercial: Covid-19 Antigen Rapid Test Kit | Device ID: 2653 | Method: | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing)Co.ltd | Commercial: COVID-19 Neutralizing Antibody Rapid Test Device | Device ID: 2287 | Method: | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mologic Ltd | Commercial: COVIOS Ag COVID-19 Antigen Rapid Diagnostic Test | Device ID: 2640 | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DS Bio and Nano Technology Product Tracking Verification Corp. | Commercial: DS AntijenX | Device ID: 2551 | Method: | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: Maverick- Nucleic Acid Extraction Kit (Magnetic Bead Based) | Device ID: 2355 | Method: | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: MEDICE Arzneimittel Pütter GmbH & Co. KG | Commercial: Medicovid-AG SARS-CoV-2 Antigen Selbsttest-Nase | Device ID: 2318 | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co., Ltd. | Commercial: Novel Coronavirus(SARS-CoV-2) Nucleic Acid Detection Kit (Isothermal Amplification) | Device ID: 2625 | Method: | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: simin.chen@lifotronic.com | Commercial: Nucleic Acid Extraction Reagent | Device ID: 2614 | Method: | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing)Co.ltd | Commercial: RAPID 2019-NCOV IGG/IGM COMBO TEST CARD | Device ID: 2286 | Method: | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: 3D Biomedicine Science & Technology Co., Limited | Commercial: Sample Transport Medium | Device ID: 2255 | Method: | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Biocomma limited | Commercial: biocomma®COVID-19 Antigen Test Kit | Device ID: 1687 | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CORMAY | Commercial: Cormay Rapid SARS-CoV-2 IgG/IgM Ab | Device ID: 1074 | Method: Chromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VEDALAB | Commercial: COVID-19-CHECK-1 test | Device ID: 1069 | 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 | Device ID: 1775 | 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 | Device ID: 1162 | 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 | Device ID: 616 | Method: Chromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan NanoDiagnosis for Health Biotechnology Co., Ltd | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette ( Colloidal Gold Method) | Device ID: 1757 | Method: Chromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ningbo Home Test Bio-echnology Co.,Ltd. | Commercial: SARS-oV- Antigen Rapid Test kit (Saliva Test) | Device ID: 2021 | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS., LTD. | Commercial: Anti-SARS-CoV-2 RBD CLIA Microparticles | Device ID: 2429 | Method: CLIA | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: DIA.CHEMILUX SARS-CoV-2 ACE2-RBD NEUTRALIZATION | Device ID: 2479 | Method: CLIA | Target: IgG | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: DIA.CHEMILUX SARS-CoV-2 NCP IgA | Device ID: 2477 | Method: CLIA | Target: IgA | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: DIA.CHEMILUX SARS-CoV-2 NCP IgG | Device ID: 2463 | Method: CLIA | Target: Antibody, IgG | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: DIA.CHEMILUX SARS-CoV-2 NCP IgM | Device ID: 2464 | Method: CLIA | Target: IgM | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: DIA.CHEMILUX SARS-CoV-2 Spike/RBD Ab | Device ID: 2478 | Method: CLIA | Target: IgG | Format: Fully automated (robot) | Go to details |
| CE Marking: No | Manufacturer: Diazyme Laboratories | Commercial: Diazyme DZ-LITE SARS-CoV-2 IgM CLIA kit | Device ID: 1416 | Method: CLIA | Target: Antibody, IgM | 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: Fujirebio Inc. | Commercial: Lumipulse G SARS-CoV-2 Ag | Device ID: 2124 | Method: CLIA | Target: Antigen | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd. | Commercial: MAGLUMI SARS-CoV-2 Ag (CLIA) | Device ID: 2187 | Method: CLIA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co., Ltd | Commercial: MAGLUMI SARS-CoV-2 Neutralizing Antibody (CLIA) | Device ID: 1491 | 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) | Device ID: 1299 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Healgen Scientific | Commercial: Rapid COVID-19 AntigenTest | Device ID: 1612 | Method: CLIA | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Antibody Assay (CLIA) | Device ID: 2213 | Method: CLIA | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Suzhou Hybiome Biomedical Engineering Co., Ltd. | Commercial: SARS-CoV-2 IgG (Chemiluminescent Immunoassay) | Device ID: 2042 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. | Commercial: SARS-CoV-2 IgG (CLIA) | Device ID: 1709 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Manual | 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 |
| CE Marking: Yes | Manufacturer: Suzhou Hybiome Biomedical Engineering Co., Ltd. | Commercial: SARS-CoV-2 IgM (Chemiluminescent Immunoassay) | Device ID: 2043 | Method: CLIA | Target: Antibody, IgM | Format: Automated, Lab-based | 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: AUTOBIO DIAGNOSTICS., LTD. | Commercial: SARS-CoV-2 NAb Q CLIA Microparticles | Device ID: 2232 | Method: CLIA | Target: Antibody | Format: Automated | 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: Zybio Inc. | Commercial: SARS-CoV-2 Neutralizing Antibody Assay (CLIA) | Device ID: 2212 | Method: CLIA | Target: Antibody | Format: Automated | 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: No | Manufacturer: MGI Tech Co., Ltd | Commercial: Fast SARS-CoV-2 NAT with CRISPR assay by digital microfluidics automation | Device ID: 483 | Method: CRISPR | Target: Nucleic acid | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Caspr Biotech | Commercial: Phantom 1.0 Dx (near POC) | Device ID: 115 | Method: CRISPR | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Sherlock Biosciences | Commercial: Rapid CRISPR-based tests for SARS-CoV-2 and other pathogens | Device ID: 645 | Method: CRISPR | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Mammoth Biosciences | Commercial: SARS-CoV-2 DETECTR | Device ID: 273 | Method: CRISPR | Target: Nucleic acid | Format: 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