CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COVID-PRESTO | Device ID: 1835 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COVID-VIRO | Device ID: 1833 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COVID-VIRO ALL IN | Device ID: 3037 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COVID-VIRO ALL IN TRIPLEX | Device ID: 3975 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Abbott Rapid Diagnostics | Commercial: Panbio Covid-19 Ag Rapid Test | Device ID: 1232 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Abingdon Health Plc | Commercial: AbC-19 Semi-Q Rapid Test | Device ID: 2879 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 Ag Rapid | Device ID: 1981 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 NAb Rapid | Device ID: 1985 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Access Bio Inc. | Commercial: CareStart(TM) COVID-19 Antigen | Device ID: 2572 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Access Bio Inc. | Commercial: CareStart(TM) COVID-19 IgM/IgG | Device ID: 2573 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: Accu-Tell COVID-19 Antigen Cassette (Nasal Swab) | Device ID: 2578 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: Accu-Tell COVID-19 Antigen Cassette (Saliva) | Device ID: 2580 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: Accu-Tell COVID-19 IgG/IgM Cassette | Device ID: 14 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: Accu-Tell SARS-CoV-2 Ag Cassette | Device ID: 2579 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: ACCU-TELL® SARS-CoV-2 Neutralizing Antibody Cassette | Device ID: 2581 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex Anti-SARS-CoV-2 S Antibody Rapid Test | Device ID: 2951 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 & Flu A/B & RSV & Adenovirus Antigen Combo Rapid Test | Device ID: 4054 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test | Device ID: 1457 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Nasopharyngeal/Saliva) | Device ID: 4057 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva) | Device ID: 1865 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test Lollipop (Saliva) | Device ID: 4050 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test Slim | Device ID: 4053 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test Slim(Self-Testing) | Device ID: 4052 | Method: Immunochromatography | Target: Antigen | Format: Other | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Saliva Rapid Test Lollipop (Self-Testing) | Device ID: 4051 | Method: Immunochromatography | Target: Antigen | Format: Other | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 & Influenza A/B Ag Combo Rapid Test | Device ID: 2594 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Self-Testing) | Device ID: 2451 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Strip | Device ID: 4045 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test | Device ID: 2603 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACON Laboratories Inc. | Commercial: FIAflex SARS-CoV-2 Antigen FIA | Device ID: 1670 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACON Laboratories Inc. | Commercial: Flowflex SARS-CoV-2 Antigen rapid test | Device ID: 1468 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ACON Laboratories Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test (Self-Testing) | Device ID: 2452 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: ACON Laboratories Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test Strip | Device ID: 1907 | 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: Actim Oy | Commercial: Actim SARS-CoV-2 + Actim Influenza A&B | Device ID: 2969 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acura Kliniken Baden-Baden GmbH | Commercial: Acura Speichel-Test Diagnos COVID-19 Antigen Saliva Test Kit | Device ID: 2459 | Method: Immunochromatography | Target: Antibody, Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: ADALTIS srl | Commercial: RAPiDgen SARS-CoV-2 Ag Test | Device ID: 2896 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ADS Biotec Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography) | Device ID: 2448 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: No | Manufacturer: ADTech Co. Ltd. | Commercial: ADTech COVID-19 Ag RAPID KIT | Device ID: 2736 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: InfectCheck® - COVID-19 IgG/IgM Test | Device ID: 2136 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: InfectCheck® COVID-19 NAb Test | Device ID: 2137 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: TestNOW® - COVID-19 Antigen Test | Device ID: 2130 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: TestNOW® - COVID-19 IgG/IgM Test | Device ID: 2132 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: TestNOW® - COVID-19 NAb Quantitative Test | Device ID: 2134 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AIETech Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Detection Kit (AIE Fluorescence Immunochromatography) | Device ID: 3036 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 3022 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Immunochromatography) | Device ID: 3016 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Saliva) | Device ID: 3023 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Test Kit(Immunochromatography) | Device ID: 3017 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Test Kit(Nasal/Nasopharyngeal/Oropharyngeal/Saliva) | Device ID: 3024 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Alphagen Bio-Technology Co.,Ltd | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 3965 | Method: Immunochromatography | Target: Antigen | 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