| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Zhejiang Orient Gene Biotech Co. Ltd. | Commercial: Sars_Cov_2 NEUTRALIZING ANTIBODY Rapid Test Cassette GCCOV(NAb)-402b | Device ID: 2497 | Method: Immunochromatography | Target: Antibody, IgG | Format: Manual, Near POC / POC, Other, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Orient Gene Biotech Co.,LTD | Commercial: COVID-19 /Flu A&B /RSV Ag Rapid Test Cassette (Swab) | Device ID: 25624 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Quark Biotechnology Co. Ltd. | Commercial: Kwork Covid-19 Ag Rapid Test Device(Saliva/Sputum/Feces) | Device ID: 1322 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhengzhou Fortune Bioscience Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Cassette (Swab) | Device ID: 1827 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhengzhou Fortune Bioscience Co. Ltd. | Commercial: COVISTIX COVID-19 VIRUS Rapid Antigen Detection Test | Device ID: 2009 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Zhengzhou Fortune Bioscience Co. Ltd. | Commercial: IgG/IgM Antibody Rapid Test Kits (Colloidal Gold Immunochromatography method) | Device ID: 699 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhengzhou Humanwell Biocell Biotechnology Co. Ltd. | Commercial: BIOCELL COVID-19 IgG ELISA test | Device ID: 453 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhengzhou Humanwell Biocell Biotechnology Co. Ltd. | Commercial: BIOCELL COVID-19 IgM ELISA test | Device ID: 454 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Encode Medical Engineering Co. Ltd. | Commercial: ENCODE SARS-COV-2 Antigen rapid Test Device | Device ID: 1902 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Encode Medical Engineering Co. Ltd. | Commercial: ENCODE SARS-COV-2 Antigen rapid Test Device | Device ID: 2587 | 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 (Saliva) | Device ID: 1616 | 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 IgG/IgM Rapid Test Device | Device ID: 985 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Zhuhai Haitai Biological Pharmaceutical Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV)/Flu A/Flu B Real-time Multiplex RT-PCR Kit (manual & automated lab-based) | Device ID: 455 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Lituo Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit (Colloidal Gold) | Device ID: 1957 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Lituo Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit (Colloidal Gold) | Device ID: 2304 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Lituo Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit (Immunofluorescence Assay) | Device ID: 1187 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Lituo Biotechnology Co. Ltd. | Commercial: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Device ID: 1186 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Lituo Biotechnology Co. Ltd. | Commercial: COVID-19/FluA/FluB Antigen Detection Kit (Colloidal Gold) | Device ID: 5792 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Livzon Diagnostics Inc. | Commercial: Diagnostic Kit for IgM / IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow) | Device ID: 879 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Zhuhai Livzon Diagnostics Inc. | Commercial: Diagnostic Kit for Nucleic Acid to nCoV-2019 (PCR- Fluorescence Probe) | Device ID: 457 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Livzon Diagnostics Inc. | Commercial: Livzon Rapid Test for SARS-CoV-2 Antigen (Lateral Flow) | Device ID: 1441 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Livzon Diagnostics Inc. | Commercial: Livzon Test for SARS-CoV-2 Antigen (Fluorescence Immunochromatographic Assay) | Device ID: 1442 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Zugotech Labs Ltd. | Commercial: Zugotech COVID-19 IgM/IgG Rapid Test | Device ID: 458 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: 2019-nCoV Neutralizing Antibody Assay (Colloidal Gold) | Device ID: 2220 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: Molaccu COVID-19 Detection Kit | Device ID: 2219 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 & Influenza A/B Antigen Assay Kit (Colloidal Gold Method) | Device ID: 2211 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 & Influenza A/B Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) | Device ID: 2221 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Antibody Assay (CLIA) | Device ID: 2213 | Method: CLIA | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Antigen Assay Kit (Colloidal Gold Method) | Device ID: 2201 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Antigen Assay Kit (Colloidal Gold Method) (self-test) | Device ID: 2987 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 IgM and IgG Antibody Assay Kit | Device ID: 637 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 IgM IgG Antibody Assay Kit (Colloidal Gold Method) | Device ID: 2209 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Neutralizing Antibody Assay (CLIA) | Device ID: 2212 | Method: CLIA | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Neutralizing Antibody Assay (ELISA) | Device ID: 2216 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) | Device ID: 2204 | Method: RT-PCR | Target: Nucleic acid | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) | Device ID: 638 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: Zybio SARS-CoV-2 Assay Kit | Device ID: 2218 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Zymo Research Corp | Commercial: Quick SARS-CoV-2 Multiplex Kit | Device ID: 1438 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, 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