| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: BIOHIT HealthCare (Hefei) Co., Ltd | Commercial: AiroStotleCV19 (Breath VOCs) | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: AcouSort | Commercial: AB Blood plasma separation using ultrasound | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: 2019-nCoV NAb Control (CLIA) | Method: Other | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: 2019-nCoV Antigen Control (CGIA) | Method: Other | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shijiazhuang Hipro Biotechnology Co.,Ltd | Commercial: 2019-nCoV IgMIgG Antibody Test Kit POCT Immunoassay System - HP-083/4 | Method: Nephelometry | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shijiazhuang Hipro Biotechnology Co.,Ltd | Commercial: 2019-nCoV IgMIgG Antibody Test Kit (Nephelometry immunoassay method) Automatic ImmunoAssay System - HP-AFS/1 | Method: Nephelometry | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co.,Ltd. | Commercial: Nucleic Acid Extraction or Purification Kit (Manual method) | Method: N.A. | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: CellSafe | Commercial: UltrFast RT-qLAMP COVID19 Detection kit | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Tebsun Bio-Tech Development Co., Ltd | Commercial: SARS-CoV-2 Nucleic Acid Test (LAMP) | Method: LAMP | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Aura Biotechnologies Ltd | Commercial: Quick COVID-19 Colorimetric LAMP PCR | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: CellSafe | Commercial: Qplex COVID-19 RT-qLAMP Assay | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Lucira Health | Commercial: Lucira COVID-19 All-In-One Test Kit | Method: LAMP | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pharmaline AS | Commercial: LAMPIGEN COVID19 RT-LAMP PCR KIT | Method: LAMP | Target: Nucleic acid | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd | Commercial: LAMP kit for qualitative detection of SARS-CoV-2 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Institute of Chemical Biology and Fundamental Medicine | Commercial: LAMP kit for qualitative detection of SARS-CoV-2 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hayat Genetics Inc | Commercial: Hayat Rapid Colorimetric & Fluorimetric One Step LAMP SARS-CoV-2 Test Kit | Method: LAMP | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: geneOmbio Technologies Pvt. Ltd | Commercial: geneOmbio COVID-19 rt-LAMP test | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: OSANG Healthcare Co., Ltd. | Commercial: GeneFinder COVID-19 Fast RealAmp Kit | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Green Cross Medical Science Corp. | Commercial: GENEDIA W COVID-19 Colorimetric LAMP premix kit | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: zenum sarl | Commercial: Zekmed antigen rapid test cassette (colloidal gold) | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PANION AND BF BIOTECH INC | Commercial: Vstrip COVID-19 Antigen Rapid Test | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: V-CHEK, 2019-nCoV Ag Rapid Test Card (Immunochromatography) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd. | Commercial: The SARS-CoV-2 Antigen Assay Kit (Immunochromatography) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC | Commercial: Test Rapid IgG/IgM 2019-nCoV | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc | Commercial: STANDARD Q COVID-19 Ag Test | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co., Ltd. | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Senova Gesellschaft für Biowissenschaft und Technik mbH | Commercial: Senova Greenlight | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Screen Italia SRL | Commercial: SCREEN TEST COVID-19 SALIVA | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Screen Italia SRL | Commercial: SCREEN TEST COVID-19 IgG/IgM - 2019-nCoV IgG/IgM Rapid Test Cassette | Method: Immunochromatography | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: InBios International | Commercial: SCoV-2 Ag Detect Rapid Test | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ScheBo Biotech AG | Commercial: ScheBo SARS CoV-2 Quick Antigen | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co., Ltd | Commercial: SARS-COV-2/Influenza A&B Rapid Antigen Test | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| 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) | Method: Immunochromatography | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: SARS-Cov-2&Influenza A&B Combo Rapid Test Cassette (swab) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Hunan Yonghe-Sun Biotechnology Co., Ltd | Commercial: SARS-COV-2 specific antibody test kit (Immunochromatography) | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Assay Kit (Immunochromatography) | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Wiz Biotech Co., Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibodies Test | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd. | Commercial: SARS-CoV-2 IgM/IgG Antibody Assay Kit (Immunochromatography) | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Kisshealth Biotechnology Co., Ltd | Commercial: SARS-CoV-2 Antigen Test Kit (GICA) | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hubei Jinjian Biology Co., Ltd | Commercial: SARS-CoV-2 Antigen Test Kit | Method: Immunochromatography | Target: Antigen | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories, Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test Strip | Method: Immunochromatography | 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 Strip | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co., Ltd | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Encode Medical Engineering Co.,Ltd | Commercial: SARS-COV-2 Antigen Rapid Test Device | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Wiz Biotech Co., Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Sputum/Saliva/Stool) | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Wiz Biotech Co., Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Saliva) | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Wiz Biotech Co., Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Selfdiagnostics Deutschland GmbH | Commercial: SARS-CoV-2 Antigen Rapid Test | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Innova Medical Group, Inc. | Commercial: SARS-CoV-2 Antigen Rapid Qualitative Test | Method: Immunochromatography | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co., Ltd | Commercial: SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) | Method: Immunochromatography | Target: Antibody | 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