| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Ag Lateral Flow Test Device | Device ID: 2320 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Antigen Fluorescence Immunoassay Kit | Device ID: 2422 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Antigen Lateral Flow Test Device | Device ID: 2408 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Neutralizing Antibody ELISA Kit | Device ID: 2424 | Method: ELISA | Target: Antibody | Format: Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Neutralizing Antibody Lateral Flow Test Kit | Device ID: 2425 | Method: Immunoassay | Target: Antibody | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoDetect COVID-19 Ag Qualitative PCR Kit | Device ID: 2358 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoDetect COVID-19 Ag Qualitative PCR Kit (Compatible with the Automated Extraction System- COMPACT X/XL) | Device ID: 2357 | Method: RT-PCR | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoDetect COVID-19 Qualitative PCR Kit | Device ID: 288 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoDetect COVID-19 Qualitative PCR Kit (Compatible with the Automated Extraction System- COMPACT X/XL) | Device ID: 2406 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: ViroTrap- Molecular Transport Medium | Device ID: 2346 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: ViroTrap- Viral Transport Medium | Device ID: 2345 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nal von minden GmbH | Commercial: dedicio® COVID-19 Ag plus Test | Device ID: 2914 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nal von minden GmbH | Commercial: dedicio® COVID-19 Ag pro Test | Device ID: 2373 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nal von minden GmbH | Commercial: NADAL COVID-19 Ag + Influenza A/B Test | Device ID: 2104 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nal von minden GmbH | Commercial: NADAL COVID-19 Ag Test | Device ID: 1162 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nal von minden GmbH | Commercial: NADAL COVID-19 IgG/IgM Test (243003N-25 and 243001N-10) | Device ID: 289 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nal von minden GmbH | Commercial: NADAL® COVID-19 Ag Test (self-testing) | Device ID: 2848 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nal von minden GmbH | Commercial: NADAL® GX COVID-19 Ag Test | Device ID: 4062 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Nanjing BioPoint Diagnostics | Commercial: BioPoint SARS-CoV-2 dIgA/total antibody rapid test | Device ID: 290 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Bioworld Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) | Device ID: 3088 | Method: Chromatography | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Bioworld Biotech Co. Ltd. | Commercial: SARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography )-Lollipop style | Device ID: 3090 | Method: Chromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Bioworld Biotech Co. Ltd. | Commercial: SARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography) | Device ID: 3089 | Method: Chromatography | Target: Antigen | Format: | Go to details |
| CE Marking: No | Manufacturer: Nanjing Liming BioProducts Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Device | Device ID: 681 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Nanjing Liming BioProducts Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit | Device ID: 680 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Liming BioProducts Co. Ltd. | Commercial: StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detection for three genes) | Device ID: 1224 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Liming BioProducts Co. Ltd. | Commercial: StrongStep® SARS-CoV-2 Antigen Rapid Test | Device ID: 2301 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Norman Biological Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold) | Device ID: 2506 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Norman Biological Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Immunochromatography) | Device ID: 3178 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Norman Biological Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) IgG / IgM Antibody Testing Kit (Colloidal Gold) | Device ID: 2515 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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: Nanjing Synthgene Medical Technology Co. Ltd. | Commercial: COVID-19 IgM/IgG Antibody Rapid Detection Kit(colloidal gold method) | Device ID: 2823 | Method: Immunoassay | Target: IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Synthgene Medical Technology Co. Ltd. | Commercial: COVID-19/Influenza A+B Antigen Combo Rapid Test Kit (Colloidal gold method) | Device ID: 3525 | Method: | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Synthgene Medical Technology Co. Ltd. | Commercial: Nanjing Synthgene Medical Technology Co., Ltd. | Device ID: 3693 | Method: | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Synthgene Medical Technology Co. Ltd. | Commercial: SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method) | Device ID: 2164 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Synthgene Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Virus Neutralization Test Kit (Colloidal gold method) | Device ID: 2822 | Method: Immunoassay | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Synthgene Medical Technology Co.， Ltd. | Commercial: SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method) | Device ID: 4067 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Vazyme Medical Technology Co. Ltd. | Commercial: 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit | Device ID: 291 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Vazyme Medical Technology Co. Ltd. | Commercial: Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit | Device ID: 1864 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Vazyme Medical Technology Co. Ltd. | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) | Device ID: 1849 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Vazyme Medical Technology Co. Ltd. | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) - Nasal swab | Device ID: 3107 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Vazyme Medical Technology Co. Ltd. | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) - self-testing | Device ID: 2983 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nano-Ditech Corporation | Commercial: Nano-Check COVID-9 IgG/IgM Antibody Test | Device ID: 938 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: NanoBio Lab A*STAR Research Entities | Commercial: Isothermal Exponential Amplification for COVID-19 Detection | Device ID: 292 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: NanoEntek | Commercial: FREND COVID-19 Ag | Device ID: 1420 | Method: Immunoassay | Target: Antigen | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: NanoEntek | Commercial: FREND COVID-19 IgG/IgM Duo | Device ID: 585 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: NanoEntek | Commercial: FREND COVID-19 SP | Device ID: 1411 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: NanoEntek | Commercial: FREND COVID-19 total Ab | Device ID: 1418 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NanoRepro AG | Commercial: NanoRepro SARS-CoV-2 Antigen Rapid Test | Device ID: 2200 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: NanoResearch | Commercial: NanoMedicina SARS-CoV-2 IgM/IgG Antibody Rapid Test | Device ID: 683 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nantong Diagnos Biotechnology Co. Ltd. | Commercial: (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold) | Device ID: 1355 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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