CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit - Nasal Swab (for Self-Test use) | Device ID: 2303 | Method: Immunoassay | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 Antigen Test Cassette (Nasopharyngeal Swab) | Device ID: 2302 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: PREMIER MEDICAL CORPORATION PRIVATE LIMITED | Commercial: SURE STATUS COVID-19 ANTIGEN CARD TEST | Device ID: 2299 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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: SureScreen Diagnostics | Commercial: SARS-CoV-2 Rapid Antigen Test Cassette | Device ID: 2297 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Nuclear Laser Medicine srl | Commercial: SArs-CoV-2 Real Time | Device ID: 2296 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Reagent Technology Co. Ltd. | Commercial: SARS-CoV-2 antigen IVD kit SALIVA | Device ID: 2295 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: No | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Coronavirus (2019-nCoV) -Antigentest-Speichel | Device ID: 2293 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Coronavirus (2019-nCoV) -Antigentest | Device ID: 2292 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Rapid Pathogen Screening Inc. | Commercial: LIAISON® Quick Detect Covid Ag Assay | Device ID: 2290 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: SARS-CoV-2 Antigen ELISA | Device ID: 2289 | Method: ELISA | Target: Antigen | Format: Automated, Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: Safecare Biotech (Hangzhou) Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit (Salivia) | Device ID: 2288 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Rapid Test Device | Device ID: 2287 | Method: | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co. Ltd. | Commercial: RAPID 2019-NCOV IGG/IGM COMBO TEST CARD | Device ID: 2286 | Method: | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co. Ltd. | Commercial: Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva) | Device ID: 2285 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Canary Global Inc. | Commercial: Pelican COVID-19 Ultra-Rapid Mobile Test | Device ID: 2283 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Becton Dickinson | Commercial: BD Kit For Rapid Detection of SARS-CoV-2 | Device ID: 2282 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: NG Biotech | Commercial: Ninonasal-Autotest | Device ID: 2281 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 & Influenza A/B Antigen Nasal Test Kit | Device ID: 2280 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Dewei Medical Equipment Co. Ltd. | Commercial: Covid-19 (2019-nCoV) Antigen Rapid Test Cassette | Device ID: 2279 | Method: Immunochromatography | Target: Antibody, Antigen, IgG | 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: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 Antigen Nasal Test Kit | Device ID: 2277 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Humasis Co. Ltd. | Commercial: Humasis COVID-19 Ag Home Test | Device ID: 2276 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Eurobio Scientific | Commercial: EurobioPlex SARS-CoV-2 SNPs | Device ID: 2275 | Method: RT-PCR | Target: | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Technogenetics SRL | Commercial: TGS Velox Ag COVID-19 POCT SALIVA (25 test) | Device ID: 2274 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Dräger Safety AG & Co. KGaA | Commercial: Dräger Antigen Test SARS-CoV-2 | Device ID: 2273 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: VITASSAY HEALTHCARE SL | Commercial: Vitassay SARS-CoV-2+Influenza A+B+RSV+Adenovirus Resp. | Device ID: 2272 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Pantest SA | Commercial: Pantest Coronavirus Ag (Nasopharyngeal Swab) | Device ID: 2271 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Device | Device ID: 2270 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Quidel Coorporation | Commercial: QuickVue SARS Antigen FIA | Device ID: 2269 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: VITASSAY HEALTHCARE SL | Commercial: Vitassay SARS-CoV-2 | Device ID: 2268 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) | Device ID: 2267 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co. Ltd. | Commercial: COVID-19 Ag Saliva Test Kit | Device ID: 2266 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ImmunoDiagnostics Limited | Commercial: COVID-19 Ag Detection Kit (Colloidal Gold Immunochromatography) | Device ID: 2265 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Xiamen Boson Biotech Co. Ltd. | Commercial: Rapid SARS-CoV-2 Antigen Test Card | Device ID: 2264 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Multi-G bvba | Commercial: Covid19Check-MG | Device ID: 2262 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Multi-G bvba | Commercial: Covid19Check-SAL | Device ID: 2261 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Multi-G bvba | Commercial: Covid19Check-NAS | Device ID: 2260 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: BOME TRIVITRON | Commercial: TRIMARIS SARS-CoV-2 RT-qPCR Kit | Device ID: 2259 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
CE Marking: Yes | Manufacturer: Multi-G bvba | Commercial: Covid19Check-GEN | Device ID: 2258 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) | Device ID: 2257 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Sigmed Sp. z o.o. | Commercial: Redtest Professional Sars-CoV-2 Antigen Rapid Test (Covid-19 Ag) | Device ID: 2256 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: 3D Biomedicine Science & Technology Co. Limited | Commercial: Sample Transport Medium | Device ID: 2255 | Method: | Target: Nucleic acid | Format: | Go to details |
CE Marking: Yes | Manufacturer: 3D Biomedicine Science & Technology Co. Limited | Commercial: 96A Viral RNA Auto Extraction & Purification Kit | Device ID: 2254 | Method: | Target: Nucleic acid | Format: | Go to details |
CE Marking: Yes | Manufacturer: 3D Biomedicine Science & Technology Co. Limited | Commercial: ANDiS Viral RNA Auto Extraction & Purification Kit | Device ID: 2253 | Method: | Target: Nucleic acid | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: 3D Biomedicine Science & Technology Co. Limited | Commercial: ANDiS FAST SARS-CoV-2 RT-qPCR Detection Kit | Device ID: 2252 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: Ningbo Beautiful Life Medical Biotechnology Development Co. Ltd. | Commercial: Saliva SARS-Cov-2(2019-nCoV) Antigen Combined Test Kit (Nanocarbon Assay) | Device ID: 2250 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Unioninvest Ltd. | Commercial: COVID-19 ANTIGEN RAPID TEST NASAL | Device ID: 2249 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: ASSUT EUROPE SPA | Commercial: SARS-CoV-2 Antigen Rapid Swab | Device ID: 2248 | Method: Immunoassay | 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