| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Surge Medical Inc. | Commercial: COVID-19 Antigen Test Kit | Method: Immunoassay | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Vazyme | Commercial: COVID-19/Influenza A virus/Influenza B virus test kit (Rare Earth Nano Fluorescence Immunochromatography) | Method: | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: OPTOLANE Technologies, Inc. | Commercial: Direct Dr. PCR™ SARS-CoV-2 Detection kit | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Coyote Bioscience Co., Ltd. | Commercial: DirectDetect SARS-CoV-2 Detection Kit (PCR-Fluorescence Probe) | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: STAB VIDA | Commercial: Dr Vida pocket for COVID-19 | Method: LAMP | Target: | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: OPTOLANE Technologies, Inc. | Commercial: Dr. PCR™ Di20K COVID-19 Detection kit | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Green Cross Medical Science Corp | Commercial: GENEDIA W COVID-19 Ag | Method: Immunoassay | Target: | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genrui Biotech Inc. | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co., Ltd. | Commercial: Nucleic Acid Extraction or Purification Kit | Method: | Target: | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: ELITechGroup S.p.A. | Commercial: SARS-CoV-2 ELITe MGB® Kit | Method: | Target: | Format: Automated, Fully automated (robot), Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co., Ltd. | Commercial: SARS-CoV-2 Fluorescent PCR Kit | Method: RT-PCR | Target: | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Tellgen Corporation | Commercial: SARS-CoV-2 Nucleic acid detection kit based on Cartridge Real-Time PCR platform | Method: RT-PCR | Target: | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Foregene Co., Ltd | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit(Multiplex PCR Fluorescent Probe Method) | Method: RT-PCR | Target: | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: CAMP MEDICA DISTRIBUTION | Commercial: See Now Coronavirus nCoV antigen test | Method: Immunochromatography | Target: | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: LLC EMG- Evotech Mirai Genomics | Commercial: SmartAmp SARS-CoV-2 RNA detection test kit | Method: LAMP | Target: | Format: Manual, Other, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Nantong Diagnos Biotechnology | Commercial: (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Natejah | Commercial: (COVID-19) IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: JinHuan Medical Instrument Co., Ltd | Commercial: (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shandong ThinkLab Biotechnology Co., Ltd | Commercial: 09-nCOV IgM/IgG antibody test kits (Colloidal-gold Assay) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd | Commercial: 2019 nCOV IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Singclean Medical Products Co., Ltd (CN); Sungo Europe B. V. (NL) | Commercial: 2019-nCoV Ab Test (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovita Biological Technology | Commercial: 2019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/Serum/Plasma Combo) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd | Commercial: 2019-nCoV IgG Antibody Determination Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: 2019-nCoV IgG Control | Method: Immunoassay | Target: Antibody | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Biolidics | Commercial: 2019-nCoV IgG/IgM Antibody Detection Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd | Commercial: 2019-nCoV IgG/IgM Device | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co., Ltd | Commercial: 2019-nCoV IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOMAXIMA S.A. | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ACRO BIOTECH, Inc. | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Safecare Biotech (Hangzhou) Co. Ltd | Commercial: 2019-nCoV IgG/IgM Rapid Test Device | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vazyme | Commercial: 2019-nCoV IgG/IgM Rapid Testing Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: U2USystems (India) Pvt. Ltd | Commercial: 2019-ncoV IgG/IgM Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prometheus Bio Inc | Commercial: 2019-nCOV IgG/IgM Test Cassette (Whole blood/Serum/Plasma) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd | Commercial: 2019-nCoV IgM Antibody Determination Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd | Commercial: 2019-nCoV IgM Antibody Diagnostic Kit (Colloidal gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: 2019-nCoV IgM Control | Method: Immunoassay | Target: Antibody | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Shijiazhuang Hipro Biotechnology Co.,Ltd | Commercial: 2019-nCoV IgMIgG Antibody Test Kit (Nephelometry immunoassay method) Automatic ImmunoAssay System - HP-AFS/1 | Method: Nephelometry | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shijiazhuang Hipro Biotechnology Co.,Ltd | Commercial: 2019-nCoV IgMIgG Antibody Test Kit POCT Immunoassay System - HP-083/4 | Method: Nephelometry | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: 2019-nCoV NAb Control (CLIA) | Method: Other | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd. | Commercial: 2019-nCoV Neutralizing Antibody Test Kit (Colloid Gold Immunoassay) | Method: | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV Neutralizing Antibody Test Kit (colloidal gold method) | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV Neutralizing Antibody Test Kit (Fluorescent immunochromatography) | Method: Immunochromatography | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Neo Nostics (Suzhou) Bioingeneering Co. LTD | Commercial: 2019-nCoV(COVID-19) IgG&IgM Rapid Test Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: 2019-nCoV-IgG Assay Reagent Kit (CMIA) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Akralab | Commercial: 2019nCoV IgG/IgM Rapid test Device | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: A&B Professional | Commercial: A&B RAPID TEST COVID-19 IGG/IGM CASSETTA | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AB Dianostic Systems GmbH | Commercial: abia SARS-CoV- IgG/IgM | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Absology Co., Ltd | Commercial: Absoludy COVID-19 IgM/IgG Rapid | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Aesku.Diagnostics | Commercial: AESKULISA SARS-CoV-2 NP IgG | Method: Immunoassay | Target: Antibody | Format: Automated, 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