| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd | Commercial: 2019-nCoV IgG Antibody Determination Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AmonMed Biotechnology Co., Ltd | Commercial: 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Hangzhou Dan Wei Biotechnology Co.Ltd | Commercial: 2019-nCoV Direct RT-qPCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Beijing Shengkun Kangru Medical Equipment Co., Ltd | Commercial: 2019-nCoV Detection kit (quantum dot immunofluorescence method) | Method: | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Biosearch Technologies | Commercial: 2019-nCoV CDC-qualified Probe and Primer Kits for SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV Antigen Test Kit (colloidal gold method) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing M&D Biotechnology Co. Ltd. | Commercial: 2019-nCoV Antigen Test Kit | Method: Immunoassay | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co., Ltd | Commercial: 2019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) | Method: Immunochromatography | Target: Antigen | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd | Commercial: 2019-nCoV Antigen Rapid Test Kit (colloidal gold assay) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co., Ltd | Commercial: 2019-nCoV Antigen Rapid Test (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics UK | Commercial: 2019-nCoV Antigen Device | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd | Commercial: 2019-nCoV Antigen Device | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: 2019-nCoV Antigen Control (IFA) | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: 2019-nCoV Antigen Control (CLIA) | Method: Immunoassay | Target: Antigen | 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: Innovita Biological Technology | Commercial: 2019-nCoV Ag Test (Latex Chromatography Assay) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Huachenyang (Shenzhen) Technology Co., Ltd. | Commercial: 2019-nCoV Ag Rapid Test Kit - REF: CY-F006-AG25 | Method: Immunochromatography | Target: Antigen | Format: Other | Go to details |
| CE Marking: No | Manufacturer: Guangdong Longsee Biomedical Co., Ltd | Commercial: 2019-nCoV Ag & Influenza AB Ag RapidCo-Detection Kit (Immuno-Chromatography) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangdong Longsee Biomedical Co., Ltd | Commercial: 2019-nCoV Ag & Influenza A/B Rapid Co-DetectionKit (Immuno-Chromatography) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovita Biological Technology | Commercial: 2019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/Serum/Plasma Combo) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Singclean Medical Products Co., Ltd (CN); Sungo Europe B. V. (NL) | Commercial: 2019-nCoV Ab Test (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| 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 and Flu A/B Antigen Combo Rapid Test Kit (Colloid Gold Immunoassay) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Kogene Biotech | Commercial: 2019 Novel Coronavirus Real-time PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Northwell Health | Commercial: 2019 Novel Coronavirus PCR | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Guangzhou HEAS BioTech Co., Ltd | Commercial: 2019 Novel Coronavirus (2019-nCoV) RNA ASSAY (PCR Fluorescent Probe Method) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Darui Biotechnology Co.,Ltd | Commercial: 2019 Novel Coronavirus (2019-nCoV) IgM Antibody Detection Kit (ELISA Method) | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Darui Biotechnology Co.,Ltd | Commercial: 2019 Novel Coronavirus (2019-nCoV) IgG Antibody Detection Kit (ELISA Method) | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Anitoa | Commercial: 2019 New Coronavirus (2019-nCoV) Test Kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Centers for Disease Control and Prevention | Commercial: 2019 nCoV Real-Time RT-PCR Diagnostic Panel | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: 2019 nCoV novel coronavirus antibody detection reagent (Colloidal gold) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Microtrace Diagnostici SRL | Commercial: 2019 NCOV IGG/IGM TEST | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd | Commercial: 2019 nCOV IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: 1drop Inc | Commercial: 1copy COVID-19 qPCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Biomeme | Commercial: 10 Minutes COVID-19 IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shandong ThinkLab Biotechnology Co., Ltd | Commercial: 09-nCOV IgM/IgG antibody test kits (Colloidal-gold Assay) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Spectrum for Diagnostic Industries | Commercial: (SDI) SARS-CoV-2 Qualitative Real Time PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Lansion Biotechnology Co., Ltd. | Commercial: (COVID-19) IgM/IgG Test Kit (Dry Fluorescence Immunoassay) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: JinHuan Medical Instrument Co., Ltd | Commercial: (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Natejah | Commercial: (COVID-19) IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nantong Diagnos Biotechnology | Commercial: (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold) | Method: Immunoassay | 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