| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Shanghai Fosun Long March Medical Science Co. Ltd. | Commercial: 2019-Novel Coronavirus (2019 - nCoV) RT-PCR Detection Kit | Device ID: 358 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Fosun Long March Medical Science Co. Ltd. | Commercial: Fosun 2019-nCoV qPCR | Device ID: 975 | 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: Fosun Covid-19 Ag CARD | Device ID: 2894 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Shanghai Fosun Long March Medical Science Co. Ltd. | Commercial: Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit | Device ID: 820 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Shanghai Fosun Long March Medical Science Co. Ltd. | Commercial: Fosun COVID-19 RT-PCR Detection Kit | Device ID: 720 | 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) Real-time Isothermal Amplification kit | Device ID: 976 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Shanghai GeneoDx Biotechnology Co. Ltd. | Commercial: Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method) | Device ID: 359 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Shanghai Igenetec Diagnostics Co. Ltd. | Commercial: Novel Coronavirus SARS-CoV-2 Nucleic Acid Detection Kit (Isothermal Amplification on Microfluidic Chip) | Device ID: 360 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai International Holding Corp. GmbH(Europe) (DE) | Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 987 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Kehua Bio-engineering Co. Ltd. | Commercial: Diagnostic kit for SARS-CoV-2 Nucleic Acid (Real-time PCR) | Device ID: 2487 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Kehua Bio-engineering Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG Antibody (Colloidal Gold) | Device ID: 871 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Shanghai Kehua Bio-engineering Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Test | Device ID: 361 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Liangrun Biomedicine Technology Co. Ltd. | Commercial: LionRunTM SARS-CoV-2 Antigen Rapid Test (Lateral Flow Immunoassay) | Device ID: 2155 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Liangrun Biomedicine Technology Co. Ltd. | Commercial: LionRun™️SARS-CoV-2 Antigen Rapid Test Kit (Lateral Flow Immunoassay) | Device ID: 1863 | Method: Immunoassay | 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: Shanghai Rendu Biotechnology Co. Ltd. | Commercial: AmpSure 2019-nCov RNA Assay | Device ID: 362 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: ShanXi Medical University | Commercial: SARS-COV-2 IgM/IgG antibody test (Colloidal Gold) | Device ID: 364 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: 2019-nCoV Nucleic acid Detection Kit (Real Time PCR) | Device ID: 2624 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: Mutation of SARS-CoV-2 nucleic acid Detection Kit（Real Time PCR） | Device ID: 2626 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit (Lateral Flow Method) (Nasal swab) | Device ID: 3104 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Detection Kit(Fluorescence Immunoassay) | Device ID: 2621 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Detection Kit (Colloidal Gold) | Device ID: 2558 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: SARS-CoV-2（ COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method) | Device ID: 2491 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method) | Device ID: 2145 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN AEHEALTH TECHNOLOGY Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 2677 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen AIVD Biotech Inc. | Commercial: COVID-19/ FluA/ FluB Antigen Combo Rapid Test Kit (Colloidal Gold Method) | Device ID: 3087 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Aivd Biotechnology Co.LTD. | Commercial: SARS-CoV-2 Antigen Detection Kit (Latex Lateral Flow Assay) | Device ID: 2834 | Method: Other | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Biocup Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Detection Kit (Latex Lateral Flow Assay) | Device ID: 1950 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Bioeasy Biotechnology Co. Ltd. | Commercial: Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence) | Device ID: 365 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Bioeasy Biotechnology Co. Ltd. | Commercial: Bioeasy 2019-Novel Coronavirus (2019-nCoV) Ag GICA Rapid Test | Device ID: 689 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen CAS-Envision Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit | Device ID: 2152 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Dakewe Bio-engineering Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit | Device ID: 1995 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Dakewe Bio-engineering Co. Ltd. | Commercial: COVID-19 IgM/IgG Rapid Test Kit | Device ID: 1998 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Dymind Biotechnology Co. Ltd. | Commercial: Sars-CoV-2 antigen test kit (colloidal gold) | Device ID: 2415 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Dymind Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 antigen test kit (Saliva sample) | Device ID: 2418 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Dymind Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG Duo Test (Colloidal Gold) | Device ID: 1161 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Everbest Machinery lndustry Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test | Device ID: 3125 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen GeneBioHealth Co. Ltd. | Commercial: SARS-CoV- IgM IgG Test Kit (Colloidal Gold) | Device ID: 946 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen GeneBioHealth Co. Ltd. | Commercial: SARS-CoV- Nucleic Acid Test Kit (RT-PCR) | Device ID: 947 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Shenzhen GeneBioHealth Co. Ltd. | Commercial: SARS-CoV-2 IgM IgG Test Kit (Colloidal Gold) | Device ID: 806 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Highcreation Technology Co. Ltd. | Commercial: Novel Corona- virus IgM/IgG Combo Rapid Test | Device ID: 1345 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Huaree Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) | Device ID: 2812 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Huian Biosci Technology Co. Ltd. | Commercial: Rapid nCoV & Flu A/B Ag Test Kit (Colloidal Gold) | Device ID: 4098 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Huian Biosci Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 3356 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Huian Biosci Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2414 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Lateral Flow Assay) | Device ID: 2166 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Kingfocus Biomedical Engineering Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit(Quantum Dots-Based Immunofluorescence Chromatography) | Device ID: 2941 | Method: Immunochromatography | Target: Antigen, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Kisshealth Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antibodies Test Kit (Latex particle-enhanced turbidimetric immunoassay) | Device ID: 1817 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Kisshealth Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (GICA) | Device ID: 1813 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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