| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: 1drop Inc | Commercial: 1copy COVID-19 qPCR Kit | Device ID: 1 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: 3D Medicines | Commercial: 2019-nCoV RT-qPCR | Device ID: 2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: 3B BlackBio Biotech India Ltd | Commercial: TRUPCR SARS-CoV-2 RT qPCR Kit | Device ID: 3 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: 3D Medicines | Commercial: 3DMed 2019-nCoV RT-qPCR Detection Kit | Device ID: 4 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AB ANALITICA Srl | Commercial: REALQUALITY RQ-2019-nCoV | Device ID: 5 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Abacus Diagnostica | Commercial: GenomEra SARS-CoV-2 | Device ID: 7 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Abbott | Commercial: Abbott RealTime SARS-CoV-2 EUA test | Device ID: 8 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Absea Biotechnology Ltd | Commercial: The non-invasive MEGA test of SARS-CoV-2 | Device ID: 9 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Abwiz Bio | Commercial: RabWiz Ultra Sensitive COIV-19 Viral Antigen Test Kit (ELISA) | Device ID: 10 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Academia Sinica | Commercial: Anti-SARS-CoV-2 nucleocapsid protein human IgM/IgG rapid detection kit | Device ID: 11 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Academia Sinica | Commercial: SARS-CoV-2 Nucleocapsid Protein Rapid Detection Kit | Device ID: 12 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: A*ccelerate | Commercial: A*STAR Fortitude Kit 2.0 (Singapore HSA) – PCR kit | Device ID: 13 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: No | Manufacturer: Acumen Research Laboratories Pte Ltd | Commercial: Acu-Corona 2.0 | Device ID: 15 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Acumen Research Laboratories Pte Ltd | Commercial: Acu-Corona | Device ID: 16 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: ADT Biotech | Commercial: LyteStar 2019-nCoV RT-PCR Kit 1.0 | Device ID: 17 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: AIVD Biotech Inc | Commercial: COVID-19 IgG/IgM Rapid Test (colloidal gold-based) | Device ID: 18 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Advanced Molecular Diagnostics | Commercial: AMD Human SARS-CoV-2 detection kit | Device ID: 19 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Aldatu Biosciences | Commercial: PANDAA qDx SARS-CoV-2 | Device ID: 20 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Alfa Scientific Designs Inc | Commercial: DrivenFlow COVID-19 | Device ID: 21 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Altona Diagnostics | Commercial: RealStar SARS-CoV-2 RT-PCR Kit | Device ID: 22 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vazyme | Commercial: COVID-19/Influenza A virus/Influenza B virus test kit (Rare Earth Nano Fluorescence Immunochromatography) | Device ID: 28 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Amoy Diagnostics Co., Ltd | Commercial: AmoyDx Novel Coronavirus (2019 nCoV) Detection Kit | Device ID: 29 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Anatolia Geneworks | Commercial: Bosphore Novel Coronavirus (2019-nCoV) Detection Kit | Device ID: 31 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Anbio (Xiamen) Biotechnology Co., Ltd | Commercial: COVID-19 Hybrid Capture Fluorescence Immunoassay Test | Device ID: 32 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anlong Gene | Commercial: Detection Kit for 2019-nCov nucleic acid (Fluorescence PCR) | Device ID: 33 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Anhui Deep Blue Medical Technology Co., Ltd | Commercial: Colloidal gold strip for SARS-CoV-2 IgG & IgM | Device ID: 34 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anlong Gene | Commercial: nConV-19 Nucleic Acid qPCR Kit | Device ID: 35 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Ativa Medical | Commercial: Ativa Enhanced Screen | Device ID: 42 | Method: Other | Target: Other | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Atila BioSystems, Inc | Commercial: Atila iAMP COVID-2019 Detection Kit | Device ID: 43 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Attomarker Ltd | Commercial: Quantitative Immuno-kinetic assay for Covid-19 IgG+IgM+IgA for a multiantigen panel with CRP | Device ID: 44 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Aurora Biomed Inc | Commercial: SARS-COV-2 Detection Kit for the VERSA Viral Detection workstation | Device ID: 45 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: AusDiagnostics | Commercial: SARS-CoV-2, Influenza and RSV 8-well | Device ID: 46 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Avioq Bio-Tech Co., Ltd | Commercial: Novel Coronavirus (2019-nCov)Antibody IgG/IgM Assay Kit (Colloidal Gold) | Device ID: 47 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Avellino Lab | Commercial: Avellino SARS-CoV-2/COVID-19 (AvellinoCoV2) | Device ID: 48 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Baiya Phytopharm, Co., Ltd | Commercial: Baiya Rapid COVID-19 IgM/IgG test kit | Device ID: 50 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Bao Ruiyuan Biotech (Beijing) Co., Ltd | Commercial: Novel Coronavivus(2019-nCov)Nucleic Acid Detection Kit-Multiple Fluorescence PCR | Device ID: 51 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co., Ltd | Commercial: Multiple Real-Time PCR Kit for Detection of 2019-nCoV (manual & automated lab-based) | Device ID: 57 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | Go to details |
| CE Marking: No | Manufacturer: Beijing Beier Bioengineering Co., Ltd | Commercial: Multiple Real-Time PCR Kit for Detection of 2019-nCoV | Device ID: 58 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Beijing Biochem Hengye Science & Technology Development Co., Ltd | Commercial: SARS-CoV-2 Real-Time RT-PCR Kit | Device ID: 59 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Beijing Bohui Innovation Biotechnology | Commercial: Fully Automated 26 Plex RES Panel Assay | Device ID: 60 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovation Biotechnology | Commercial: Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Microfluidic Chip) | Device ID: 61 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd | Commercial: 2019-nCoV IgM Antibody Determination Kit | Device ID: 62 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd | Commercial: 2019-nCoV IgG Antibody Determination Kit | Device ID: 63 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Beijing Genskey Medical Technology Co., Ltd | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (RT-qPCR with Taqman-Probe) | Device ID: 64 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Beijing Infervision Technology Co. Ltd | Commercial: InferRead CT Pneumonia | Device ID: 65 | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 IgM antibody ELISA Test Kit | Device ID: 67 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 IgG antibody ELISA Test Kit | Device ID: 69 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 Antigen Rapid Test Kit (FIA) | Device ID: 70 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 IgG/IgM antibody Rapid Test Kit (Colloidal Gold) | Device ID: 71 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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