| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: BioGnost Ltd. | Commercial: CoviGnost AG Test Device 1x20 | Device ID: 2247 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SPESERA SAĞLIK ÜRÜNLERİ İÇ VE DIŞ Ltd. ŞTİ. | Commercial: Covid-19 Antigen Rapid Test Cassette | Device ID: 2246 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Actim Oy | Commercial: Actim SARS-CoV-2 | Device ID: 2245 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co. Ltd. | Commercial: V-Chek 2019-nCoV Ag Speichel Schnelltestkarte HGH | Device ID: 2244 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc. | Commercial: PCL COVID19 Ag Gold | Device ID: 2243 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DNA Diagnostic | Commercial: COVID-19 Antigen Detection Kit | Device ID: 2242 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NESAPOR EUROPA SL | Commercial: MARESKIT | Device ID: 2241 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Salofa Oy | Commercial: Salocor SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 2240 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anbio (Xiamen) Biotechnology Co. Ltd. | Commercial: Rapid COVID-19 Antigen Test（Colloidal Gold） | Device ID: 2239 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Healgen Scientific | Commercial: Clinitest Rapid Covid-19 Antigen Self Test | Device ID: 2238 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Neomedica d.o.o. | Commercial: SARS-COV-2 Ag NeoMedica | Device ID: 2236 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Neomedica d.o.o. | Commercial: SARS-COV-2 Ag NeoMedica (R2703Ag) | Device ID: 2234 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 2233 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Method) | Device ID: 2230 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Roche (SD BIOSENSOR) | Commercial: SARS-CoV-2 Rapid Antigen Test Nasal | Device ID: 2228 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics UK Ltd. | Commercial: 2019-nCoV Neutralising Antibody | Device ID: 2227 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ZET medikal tekstil dis tic Ltd. sti | Commercial: SOFTEC SARS COV-2 COVID-19 ANTIGEN TEST KIT | Device ID: 2226 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV Neutralising Antibody | Device ID: 2225 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual, 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: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: Seinofy COVID-19 Antigen Rapid Test | Device ID: 2223 | Method: Immunoassay | Target: Antigen | Format: Lab-based, Manual | 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: 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: 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: iXensor | Commercial: PixoTest® POCT COVID-19 Antigen Test | Device ID: 2217 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-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: Thyrolytics AB | Commercial: Viraspec SARS-CoV-2 Antigen Rapid Test | Device ID: 2215 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: R-Biopharm AG | Commercial: RIDA®QUICK SARS-CoV-2 Antigen | Device ID: 2214 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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 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 & 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: Hangzhou Singclean Medical Products Co. Ltd. | Commercial: COVID-19 Test Kit (Colloidal Gold Method) | Device ID: 2210 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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: Bioneovan Co. Ltd. | Commercial: COVID-19 IgM Antibody Test Kit (Colloidal Gold) | Device ID: 2208 | Method: Immunochromatography | Target: IgM | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioneovan Co. Ltd. | Commercial: COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold) | Device ID: 2207 | Method: Immunochromatography | Target: IgG, IgM | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioneovan Co. Ltd. | Commercial: COVID-19 IgG Antibody Test Kit (Colloidal Gold) | Device ID: 2206 | Method: Immunochromatography | Target: IgG | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioneovan Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Test Kit (Colloidal Gold) | Device ID: 2205 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Near POC / POC | 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: Diasia Biomedical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 2203 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: No | Manufacturer: OFM Medical | Commercial: OFM GmbH | Device ID: 2202 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: 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: Yes | Manufacturer: Safecare Biotech (Hangzhou) Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Rapid Test Kit( Whole blood/Serum/Plasma) | Device ID: 2199 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Deep Blue Medical Technology Co. Ltd. | Commercial: COVID-19 (SARS-CoV-2) Neutralizing Antibody IgG Test Kit (Colloidal Gold) | Device ID: 2198 | Method: Immunochromatography | Target: IgG | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pierenkemper GmbH | Commercial: (SARS-CoV-2) Antigen Rapid Test COVIDENT COVID-19 / Saliva | Device ID: 2197 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ASSUT EUROPE SPA | Commercial: COVID-19 N.A.T. Neutralizing Antibodies Test | Device ID: 2195 | Method: Other | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BN Santé | Commercial: SARS-CoV-2 IgG/IgM Rapid Test | Device ID: 2194 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Devidia GmbH | Commercial: Dediatest IgG-Spike | Device ID: 2193 | Method: Immunochromatography | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Devidia GmbH | Commercial: Dediatest Frontnasal SARS-CoV Antigen Schnelltest | Device ID: 2192 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Immunochromatography) | Device ID: 2191 | Method: Immunochromatography | Target: Antigen | 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