| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Anhui Formaster Biosci Co. Ltd. | Commercial: New Coronavirus (COVID-19) Antigen Rapid Test | Device ID: 2089 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Delta Chemie Biotechnology SAS | Commercial: OneCheck Covid-19 Ag | Device ID: 2088 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lifotronic Technology Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Gene Mutation) | Device ID: 2087 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lifotronic Technology Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Freeze-Dried) | Device ID: 2086 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou GENESIS Biodetection and Biocontrol Co. Ltd. | Commercial: KaiBiLi COVID-19 Antigen | Device ID: 2085 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Vircell s.l. | Commercial: SARS-COV-2 VARIANTS REALTIME PCR KIT | Device ID: 2084 | Method: RT-PCR | Target: Nucleic acid, RNA | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: SARS-CoV-2/FLU/RSV REALTIME PCR KIT | Device ID: 2083 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: DIRECT SARS-COV-2 REALTIME PCR KIT | Device ID: 2082 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: COVID-19 SPIKE QUANTITATIVE VIRCLIA® IgG MONOTEST | Device ID: 2081 | Method: Immunoassay | Target: Antibody, IgG | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Procomcure Biotech GmbH | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 2080 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: ArcDia International Ltd. | Commercial: mariPOC Quick Flu+ | Device ID: 2079 | Method: Immunoassay | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ArcDia International Ltd. | Commercial: mariPOC Respi+ | Device ID: 2078 | Method: Immunoassay | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioneovan Co. Ltd. | Commercial: Bioneovan COVID-19 Antigen Test Kit (Colloidal Gold) | Device ID: 2077 | 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 (Nasal Swab) | Device ID: 2076 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Amazing Biotech (Shanghai) Co. Ltd. | Commercial: COVID-19 Antigen Sealing Tube Test Strip (Colloidal Gold) | Device ID: 2075 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Triplex International Biosciences (China) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 2074 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: VIDIA spol. s r.o. | Commercial: Rapid-VIDITEST SARS-CoV-2 Antigen | Device ID: 2073 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Jinwofu Bioengineering Technology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit | Device ID: 2072 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Foregene Co. Ltd. | Commercial: SARS-CoV-2 Variant Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method) | Device ID: 2071 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: No | Manufacturer: Vision Biyoteknoloji AraÅŸtırma GeliÅŸtirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited Åžirketi | Commercial: VISION® COVID-19 AG RAPID TEST | Device ID: 2070 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: intron biotechnology | Commercial: LiliF GBN Covid-19 Ag Rapid kit | Device ID: 2069 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (colloidal gold method) nasal swab | Device ID: 2068 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (colloidal gold method) | Device ID: 2067 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: EXPERTEAM SRL | Commercial: EXPERT COVID-19 VRT KIT 2-RQ | Device ID: 2065 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: EXPERTEAM SRL | Commercial: EXPERT COVID-19 KIT 1-RQ | Device ID: 2064 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test Cassette | Device ID: 2063 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette | Device ID: 2062 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VIDIA spol. s r.o. | Commercial: SARS-CoV-2 Antigen | Device ID: 2061 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc. | Commercial: Dia Sure COVID-19 Antigen Rapid Test Device | Device ID: 2060 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Bioer Technology Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG Antibody Test Kit (colloidal gold method) | Device ID: 2059 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Bioer Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (colloidal gold method) | Device ID: 2058 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Jiqing Biomedical Technology Co. Ltd. | Commercial: Gruenbanka SARS-CoV-2 Antigen Testkit | Device ID: 2057 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: iSIA | Device ID: 2056 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovation Biotechnology Co. Ltd. | Commercial: COVlD-19 IgM/IgG Antibodies Rapid Test(Colloidal GoId Method) | Device ID: 2055 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: TODA PHARMA | Commercial: TODA Autotest Nasal Covid-19 | Device ID: 2054 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: FAGO MEDÄ°KAL SANAYÄ° TÄ°CARET Ltd. ÅžTÄ°. | Commercial: FAMEX Coronavirus (2019-nCoV) Antigentest | Device ID: 2053 | Method: Immunochromatography | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc. | Commercial: STANDARD Q COVID-19 Ag Test Nasal | Device ID: 2052 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MedicalSystem Biotechnology Co. Ltd. | Commercial: Coronavirus Disease 2019 Real Time PCR Kit | Device ID: 2051 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MedicalSystem Biotechnology Co. Ltd. | Commercial: Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit | Device ID: 2050 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: MedicalSystem Biotechnology Co. Ltd. | Commercial: COVID-19 Ag Rapid Test Cassette | Device ID: 2049 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Double Antigen Sandwich Colloidal Gold Immunochromatography) | Device ID: 2048 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Quantum Dots Fluorescence Immunoassay) | Device ID: 2047 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit | Device ID: 2046 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody Detection Kit (Competitive ELISA) | Device ID: 2045 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold) | Device ID: 2044 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Suzhou Hybiome Biomedical Engineering Co. Ltd. | Commercial: SARS-CoV-2 IgM (Chemiluminescent Immunoassay) | Device ID: 2043 | Method: CLIA | Target: Antibody, IgM | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Suzhou Hybiome Biomedical Engineering Co. Ltd. | Commercial: SARS-CoV-2 IgG (Chemiluminescent Immunoassay) | Device ID: 2042 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Vacure Prelab Medical Technology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit (Immunochromatography) | Device ID: 2041 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sensing Self Pte. Ltd. | Commercial: Novel Coronavirus Neutralizing Antibody Rapid Test Kit | Device ID: 2040 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sensing Self Pte. Ltd. | Commercial: S2 Covid-19 Rapid Antigen Test Kit | Device ID: 2039 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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