| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: NanoBio Lab A*STAR Research Entities | Commercial: Isothermal Exponential Amplification for COVID-19 Detection | Device ID: 292 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Kephera Diagnostics | Commercial: KDx COVID-19 Antigen Detection Rapid Test | Device ID: 244 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Kephera Diagnostics | Commercial: KDx COVID-19 IgG and IgM ELISA (manual) | Device ID: 243 | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Kephera Diagnostics | Commercial: KDx COVID-19 IgG/IgM Rapid Detection Test Kit | Device ID: 242 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Laboratory Corporation of America | Commercial: LabCorp 2019 Novel Coronavirus test | Device ID: 255 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Hangzhou Bigfish Bio-tech Co. Ltd. | Commercial: LAMP kit for qualitative detection of SARS-CoV-2 | Device ID: 210 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Institute of Chemical Biology and Fundamental Medicine | Commercial: LAMP kit for qualitative detection of SARS-CoV-2 | Device ID: 223 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Leadgene Biomedical Inc. | Commercial: Leadgene SARS/SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 257 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Leadgene Biomedical Inc. | Commercial: Leadgene SARS/SARS-CoV-2 IgG/IgM Rapid Test Kit | Device ID: 258 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Sultan lab | Commercial: Leucia immune | Device ID: 2931 | Method: Other | Target: Antibody, Antigen, IgA, IgG, IgM | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: LightMix Modular SARS-CoV-2 (COVID19) E-gene | Device ID: 409 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: LightMix Modular SARS-CoV-2 (COVID19) N-gene | Device ID: 408 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: LightMix Modular SARS-CoV-2 (COVID19) RdRP-gene | Device ID: 410 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Lucira Health | Commercial: Lucira COVID-19 All-In-One Test Kit | Device ID: 1374 | Method: LAMP | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: SignalDT Biotechnologies (SZ) Inc. | Commercial: LyoDx A Freeze-Dried Real-Time RT-PCR Detection Reagent for SARS-CoV-2 | Device ID: 373 | Method: RT-PCR | Target: Other | 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: IVDbio Inc. | Commercial: Machine-Free, Fast and Accurate Nucleic Acid Diagnoses System for COVID-19 | Device ID: 232 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Diazyme Laboratories | Commercial: Macurra SARS-CoV-2 PCR Kit | Device ID: 1417 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Genes2life SAPI de CV | Commercial: Master Mut | Device ID: 4138 | Method: RT-PCR | Target: cDNA, DNA, Nucleic acid, RNA | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Genalyte | Commercial: Maverick SARS-CoV-2 Multi-Antigen Serology Panel | Device ID: 721 | Method: Immunoassay | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Lumex Instruments | Commercial: Microchip RT-PCR COVID-19 detection system | Device ID: 580 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Mologic Ltd. | Commercial: Mologic COVID-19 Rapid Test | Device ID: 287 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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: Tetracore Inc. | Commercial: Multiplex detection and differentiation SARS-Cov-2 Serology Assay (manual) | Device ID: 401 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Medigen Vaccine Biologics Corp. | Commercial: MVC SARS-CoV-2 Convective PCR Diagnostic Device/Kit | Device ID: 581 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: NanoResearch | Commercial: NanoMedicina SARS-CoV-2 IgM/IgG Antibody Rapid Test | Device ID: 683 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Module Innovations Private Ltd. | Commercial: nCoVSENSe: IgM/ IgG test for spike and N-protein of SARS-CoV 2 (manual) | Device ID: 284 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: NEMHESIS LAB. SÄ°S. MED. PLAS. ENJEK. Ä°ML. Ä°TH. Ä°HR. SAN. TÄ°C. Ltd. ÅžTÄ°. | Commercial: NEMI COVID-19 RAPID ANTIGEN TEST KIT | Device ID: 3155 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Hangzhou Testsea Biotechnology Co. Ltd. | Commercial: New Coronavirus COVID-19 Nucleic Acid Detection Kit (Fluorescent PCR Method) | Device ID: 215 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Chinese National Institute for Viral Disease Control and Prevention | Commercial: New coronavirus nucleic acid assay | Device ID: 127 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: NY State Department of Health | Commercial: New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel | Device ID: 302 | Method: RT-PCR | Target: IgA, IgG, IgM, Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Twist Bioscience | Commercial: NGS-based target capture for SARS-CoV-2 detection and screening | Device ID: 412 | Method: Sequencing | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: ISIA | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Test Kit (Colloidal Gold Immunochromatography) | Device ID: 1639 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: ISIA | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Test Kit (Quantum Dots Immunofluorescence) | Device ID: 1640 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: INNOVITA (Tangshan) Biological Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit (Multiple Fluorescence PCR) | Device ID: 226 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Zhuhai Haitai Biological Pharmaceutical Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV)/Flu A/Flu B Real-time Multiplex RT-PCR Kit (manual & automated lab-based) | Device ID: 455 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Elabscience | Commercial: Novel Coronavirus (SARS-CoV-2) Nucleic Acid Assay Kit (RT-PCR) | Device ID: 546 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based | Go to details |
| CE Marking: No | Manufacturer: TargetingOne | Commercial: Novel Coronavirus (SARS-CoV-2) nucleic acid detection kit (Digital PCR method) | Device ID: 398 | Method: Digital-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Shandong Shtars Biological Industry Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Real Time Multiplex RT-PCR Kit User Manual | Device ID: 356 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Darui Biotechnology Co. Ltd. | Commercial: Novel Coronavirus 2019-nCoV IgG Antibody Detection Kit (Colloidal Gold Method) | Device ID: 198 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Darui Biotechnology Co. Ltd. | Commercial: Novel Coronavirus 2019-nCoV IgM Antibody Detection Kit (Colloidal Gold Method) | Device ID: 197 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Shanghai GeneoDx Biotechnology Co. Ltd. | Commercial: Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method) | Device ID: 359 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Microdiag Biomedicine Technology Co. Ltd. | Commercial: Novel coronavirus 2019-nCoV nucleic acid detection kit (rRT- PCR method) | Device ID: 238 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: BioReference Laboratories | Commercial: Novel Coronavirus COVID-19 | Device ID: 100 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: H-Guard | Commercial: Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold) | Device ID: 1636 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Beijing Decombio Biotechnology | Commercial: Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette | Device ID: 666 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Shanghai Igenetec Diagnostics Co. Ltd. | Commercial: Novel Coronavirus SARS-CoV-2 Nucleic Acid Detection Kit (Isothermal Amplification on Microfluidic Chip) | Device ID: 360 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: NorthShore University HealthSystem | Commercial: Novel Coronavirus test | Device ID: 299 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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 |
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