| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Bionote, Inc | Commercial: NowCheck COVID-19 Ag Test | Device ID: 1242 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mobidiag | Commercial: Novodiag COVID-19 | Device ID: 936 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Apollo Biomedical LLC | Commercial: Novel SARS-CoV-2 Coronavirus Spike Glycoprotein Detection Kit (S Protein-ACE2 receptor) | Device ID: 1289 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TBG BIOTECHNOLOGY XIAMEN Inc | Commercial: Novel Coronavirus(SARS-CoV-2) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Device ID: 1339 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Yuno Diagnostics Co., Ltd | Commercial: Novel coronavirus(SARS-CoV-2) IgG/IgM Antibody Combined Test Kits | Device ID: 444 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MR Healthcare | Commercial: Novel Coronavirus(COVID-19) Test | Device ID: 1021 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd | Commercial: Novel Coronavirus(2019-nCov)RT-PCR Kit | Device ID: 151 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Deangel Biological Engineering Co., Ltd | Commercial: Novel Coronavirus S Glycoprotein Detection Kit | Device ID: 1259 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech, Inc | Commercial: Novel Coronavirus Real Time PCR Kit | Device ID: 892 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sensing Self Pte. Ltd. | Commercial: Novel Coronavirus Neutralizing Antibody Rapid Test Kit | Device ID: 2040 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: Novel coronavirus neutralizing antibody Rapid Test Device | Device ID: 1896 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: Novel Coronavirus Neutralizing Antibody Assay Reagent Kit | Device ID: 1802 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Easydiagnosis Biomedicine Co., Ltd | Commercial: Novel Coronavirus IgM antibody test kit (colloidal gold method) | Device ID: 430 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Easydiagnosis Biomedicine Co., Ltd | Commercial: Novel Coronavirus IgG antibody test kit (colloidal gold method) | Device ID: 432 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biocomma limited | Commercial: Novel Coronavirus COVID-19 IgM/IgG Test Kit | Device ID: 1686 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd. | Commercial: Novel Coronavirus 2019-nCOV Nucleic Acid Typing Test Kit (Real-Time PCR) | Device ID: 1971 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: OACP IE LTD | Commercial: Novel Coronavirus 2019-nCOV Nucleic Acid Typing Test Kit (Real-Time PCR Method) | Device ID: 2443 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovation Biotechnology | Commercial: Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Microfluidic Chip) | Device ID: 61 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co., Ltd | Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) - Saliva | Device ID: 1798 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co., Ltd | Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) | Device ID: 1870 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioteke Taizhou Biotechnology Co., Ltd | Commercial: Novel Coronavirus (SARS-CoV-2) nucleic acid detection kit (Fluorescence PCR method) | Device ID: 1486 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co., Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody Detection Kit (Competitive ELISA) | Device ID: 2045 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co., Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Quantum Dots Fluorescence Immunoassay) | Device ID: 2047 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co., Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Double Antigen Sandwich Colloidal Gold Immunochromatography) | Device ID: 2048 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co., Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold) | Device ID: 2044 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Jinwofu Bioengineering Technology Co.,Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit | Device ID: 2072 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva) | Device ID: 1796 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) | Device ID: 2018 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Realy Tech | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 2298 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing)Co.ltd | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 2284 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co.,ltd | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 2331 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech (Beijing) Co.,ltd | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 2278 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 1220 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Fanttest Biotech Co.,Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette | Device ID: 2153 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen rapid test | Device ID: 1743 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Avioq Bio-Tech Co., Ltd | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit(Colloidal Gold) | Device ID: 1972 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vacure Prelab Medical Technology Co., Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit (Immunochromatography) | Device ID: 2041 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Outdo Biotech Co., Ltd | Commercial: Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test (Colloidal Gold) | Device ID: 614 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shaanxi Lifegen Co., Ltd | Commercial: Novel coronavirus (COVID-19) nucleic acid detection kit (fluorescent PCR method) | Device ID: 355 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Norman Biological Technology Co.,Ltd | Commercial: Novel Coronavirus (COVID-19) Neutralizing Antibody Testing Kit (Colloidal Gold) | Device ID: 2514 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Laihe Biotech Co., Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Testkit (Colloidal Gold | Device ID: 2224 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Medakit Ltd | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) | Device ID: 1784 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BN Santé | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) | Device ID: 1828 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chuangkun Biotech Inc. | Commercial: Novel Coronavirus (2019-nCoV）RT-PCR Detection Kit (Lyophilized) | Device ID: 2421 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Fosun Long March Medical Science Co., Ltd | Commercial: Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit | Device ID: 975 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech, Inc | Commercial: Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit | Device ID: 189 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Fosun Long March Medical Science Co., Ltd | Commercial: Novel Coronavirus (2019-nCoV) Real-time Isothermal Amplification kit | Device ID: 976 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: DAAN Gene Co., Ltd of Sun Yat-sen University | Commercial: Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR kit | Device ID: 144 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sansure Biotech, Inc | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Device ID: 342 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genrui Biotech Inc | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) | Device ID: 1925 | Method: RT-PCR | 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