| CE Marking | Detection Principle | Manufacturer | Commercial Name | Target | Format | Commercial Status | Navigate |
|---|---|---|---|---|---|---|---|
| No | ImmunoAssay-Antibody | Nantong Diagnos Biotechnology | (2019-n.CoV) New coronavirus Antibody Test (Colloidal Gold) | Antibody | Commercialized | Go to details | |
| Yes | ImmunoAssay-Antibody | Natejah | (COVID-19) IgG/IgM Rapid Test | IgG, IgM | Rapid diagnostic test | Commercialized | Go to details |
| Yes | ImmunoAssay-Antibody | JinHuan Medical Instrument Co., Ltd | (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) | IgG, IgM | Rapid diagnostic test | Commercialized | Go to details |
| No | NucleicAcid-PCR based | Spectrum for Diagnostic Industries | (SDI) SARS-CoV-2 Qualitative Real Time PCR Kit | Nucleic acid | Manual NAT | Commercialized | Go to details |
| Yes | ImmunoAssay-Antibody | Shandong ThinkLab Biotechnology Co., Ltd | 09-nCOV IgM/IgG antibody test kits (Colloidal-gold Assay) | IgG, IgM | Manual or automated | Commercialized | Go to details |
| No | ImmunoAssay-Antibody | Biomeme | 10 Minutes COVID-19 IgG/IgM Rapid Test | IgG, IgM | Rapid diagnostic test | Commercialized | Go to details |
| Yes | NucleicAcid-PCR based | 1drop Inc. | 1copy™ COVID-19 qPCR Kit | Nucleic acid | Manual NAT | Commercialized | Go to details |
| Yes | ImmunoAssay-Antibody | Dynamiker Biotechnology (Tianjin) Co., Ltd. | 2019 nCOV IgG/IgM Rapid Test | IgG, IgM | Rapid diagnostic test | Commercialized | Go to details |
| No | ImmunoAssay-Antibody | Microtrace Diagnostici SRL | 2019 NCOV IGG/IGM TEST | IgG, IgM | Commercialized | Go to details | |
| Yes | ImmunoAssay-Antibody | Edinburgh Genetics Limited | 2019 nCoV novel coronavirus antibody detection reagent (Colloidal gold) | IgG, IgM | Rapid diagnostic test | Commercialized | Go to details |
| No | NucleicAcid-PCR based | Centers for Disease Control and Prevention | 2019 nCoV Real-Time RT-PCR Diagnostic Panel | Nucleic acid | Manual NAT | Commercialized | Go to details |
| No | NucleicAcid-PCR based | Anitoa | 2019 New Coronavirus (2019-nCoV) Test Kit | Nucleic acid | Manual or automated | Commercialized | Go to details |
| No | ImmunoAssay-Antibody | Guangzhou Darui Biotechnology Co.,Ltd | 2019 Novel Coronavirus (2019-nCoV) IgG Antibody Detection Kit (ELISA Method) | IgG | Manual or automated | Commercialized | Go to details |
| No | ImmunoAssay-Antibody | Guangzhou Darui Biotechnology Co.,Ltd | 2019 Novel Coronavirus (2019-nCoV) IgM Antibody Detection Kit (ELISA Method) | IgM | Manual or automated | Commercialized | Go to details |
| No | NucleicAcid-PCR based | Guangzhou HEAS BioTech Co., Ltd | 2019 Novel Coronavirus (2019-nCoV) RNA ASSAY (PCR Fluorescent Probe Method) | Nucleic acid | Manual NAT | Commercialized | Go to details |
| No | NucleicAcid-PCR based | Northwell Health | 2019 Novel Coronavirus PCR | Nucleic acid | N.A. | In development | Go to details |
| Yes | NucleicAcid-PCR based | Kogene Biotech | 2019 Novel Coronavirus Real-time PCR Kit | Nucleic acid | Manual NAT | Commercialized | Go to details |
| Yes | ImmunoAssay-Antibody | Hangzhou Singclean Medical Products Co., Ltd. (CN); Sungo Europe B. V. (NL) | 2019-nCoV Ab Test (Colloidal Gold) | IgG, IgM | Rapid diagnostic test | Commercialized | Go to details |
| Yes | ImmunoAssay-Antibody | Innovita Biological Technology | 2019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/Serum/Plasma Combo) | IgG, IgM | Rapid diagnostic test | Commercialized | Go to details |
| No | NucleicAcid-PCR based | Biosearch Technologies | 2019-nCoV CDC-qualified Probe and Primer Kits for SARS-CoV-2 | Nucleic acid | Commercialized | Go to details | |
| No | NucleicAcid-PCR based | Beijing Shengkun Kangru Medical Equipment Co., Ltd. | 2019-nCoV Detection kit (quantum dot immunofluorescence method) | Nucleic acid | Manual or automated | In development | Go to details |
| No | NucleicAcid-PCR based | Hangzhou Dan Wei Biotechnology Co.Ltd | 2019-nCoV Direct RT-qPCR Kit | Nucleic acid | Manual NAT | In development | Go to details |
| Yes | ImmunoAssay-Antibody | AmonMed Biotechnology Co., Ltd | 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) | Antibody | Rapid diagnostic test | Commercialized | Go to details |
| Yes | ImmunoAssay-Antibody | Beijing Diagreat Biotechnologies Co., Ltd | 2019-nCoV IgG Antibody Determination Kit | IgG | Rapid diagnostic test | Commercialized | Go to details |
| Yes | ImmunoAssay-Antibody | Dynamiker Biotechnology (Tianjin) Co., Ltd. | 2019-nCOV IgG Antibody kit (ELISA) | IgG | Manual or automated | Commercialized | 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