| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: DNA Research Center Ltd. | Commercial: CBDNA RT-LAMP RAPID TEST | Device ID: 2607 | Method: LAMP | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: COMPACT X/COMPACT XL- Nucleic Acid Sample Extraction and Preparation Instrument | Device ID: 2344 | Method: RT-PCR | Target: | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: OACP IE LTD | Commercial: Corona Virus Disease 2019 (COVID-19) Nucleic Acid Detection Kit | Device ID: 2442 | Method: RT-PCR | Target: | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: genedrive | Commercial: COV19-ID Kit | Device ID: 2524 | Method: LAMP | Target: | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: WIZCHEM CO., LTD. | Commercial: COVICHEK COVID-19 Ag Saliva HT | Device ID: 2652 | Method: Immunochromatography | Target: | Format: | Go to details |
| CE Marking: No | Manufacturer: Dynamic Code AB | Commercial: Covid-19 PCR | Device ID: 2550 | Method: RT-PCR | Target: | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: cue health Inc. | Commercial: cue health | Device ID: 2655 | Method: Digital-PCR | Target: | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: mosaiques diagnostics GmbH | Commercial: DiaPat-CoV-50 | Device ID: 2407 | Method: Other | Target: | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: SolGent Co., Ltd. | Commercial: DiaPlexQ™ COVID-19 (N, ORF1a) Detection Kit | Device ID: 2493 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Eurobio Scientific | Commercial: EurobioPlex SARS-CoV-2 SNPs | Device ID: 2275 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: GVS S.p.A. | Commercial: Flame CoViD -19 VARIANTS qPCR Master Kit – CE-IVD | Device ID: 2445 | Method: RT-PCR | Target: | Format: Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Genes Laboratories | Commercial: GCdia™ COVID-19 Fast Detection Kit | Device ID: 2656 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: GSD NovaPrime® Plus SARS-CoV-2 | Device ID: 2321 | Method: RT-PCR | Target: | Format: Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: GSD NovaType II SARS-CoV-2 | Device ID: 2322 | Method: RT-PCR | Target: | Format: Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Biocartis | Commercial: IdyllaTM SARS-COV-2/FLU/RSV Panel | Device ID: 2663 | Method: RT-PCR | Target: | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: BioMol Laboratories srl | Commercial: INFET-002-100 SARS-COV-2 RT-PCR KIT VIRAL 3 | Device ID: 2361 | Method: RT-PCR | Target: | Format: Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC SRL | Commercial: Kit Multiplex (q)RT-PCR(X) for detection of SARS-CoV-2 | Device ID: 2657 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou LifeReal Biotechnology Co., Ltd. | Commercial: LifeReady 1000 automatic integrated gene detection system | Device ID: 2556 | Method: RT-PCR | Target: | Format: Automated, Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: LoopDeeScience | Commercial: LoopDeetect COVID 19 IC | Device ID: 2622 | Method: LAMP | Target: | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: Maverick- Nucleic Acid Extraction Kit (Magnetic Bead Based) | Device ID: 2355 | Method: | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: Maverick- Nucleic Acid Extraction Kit (Spin Column Based) | Device ID: 2347 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Rapid Diagnostic Systems Limited | Commercial: NaorCov19 | Device ID: 2548 | Method: LAMP | Target: | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins GeneScan Technologies GmbH | Commercial: NovaPrime IVD RNA Extraction AE1 | Device ID: 2664 | Method: Other | Target: | Format: Automated, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech, Inc | Commercial: One Step Test for SARS-CoV-2 Total Antibody /Neutralizing Antibody (Colloidal Gold) | Device ID: 2589 | Method: Immunoassay | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc. | Commercial: PCL COVID19 Ag Gold | Device ID: 2243 | Method: Immunochromatography | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: QuantuMDx Group Ltd | Commercial: Q-POC | Device ID: 2646 | Method: RT-PCR | Target: | Format: Automated, Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genomtec S.A. | Commercial: SARS-CoV-2 EvaGreen® Direct-RT-LAMP CE-IVD Kit | Device ID: 2446 | Method: LAMP | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lifotronic Technology Co.,Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method) | Device ID: 2613 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: ViennaLab Diagnostics GmbH | Commercial: SARS-CoV-2 RealFast™ Assay | Device ID: 2530 | Method: RT-PCR | Target: | Format: Automated, Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: ViroTrap- Molecular Transport Medium | Device ID: 2346 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: ViroTrap- Viral Transport Medium | Device ID: 2345 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genobio Pharmaceutical Co., Ltd. | Commercial: Virusee® SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) | Device ID: 2642 | Method: Immunoassay | Target: | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Microtrace Diagnostici SRL | Commercial: 2019 NCOV IGG/IGM TEST | Device ID: 1020 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Darui Biotechnology Co.,Ltd | Commercial: 2019 Novel Coronavirus (2019-nCoV) IgG Antibody Detection Kit (ELISA Method) | Device ID: 196 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Darui Biotechnology Co.,Ltd | Commercial: 2019 Novel Coronavirus (2019-nCoV) IgM Antibody Detection Kit (ELISA Method) | Device ID: 195 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Singclean Medical Products Co., Ltd | Commercial: 2019-nCoV Ab Test (Colloidal Gold) | Device ID: 1000 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Intermedical SRL | Commercial: 2019-NCOV IGG/IGM | Device ID: 1011 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Hangzhou AllTest Biotech Co., Ltd | Commercial: 2019-nCoV IgG/IgM Rapid Test Dipstick | Device ID: 674 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: 2019-nCoV NAb Control (CLIA) | Device ID: 1706 | Method: Other | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd | Commercial: 2019-nCoV Neutralising Antibody | Device ID: 2225 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics UK (NI) Ltd | Commercial: 2019-nCoV Neutralising Antibody | Device ID: 2227 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: 2019-nCoV Neutralizing Antibody Assay (Colloidal Gold) | Device ID: 2220 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: INNOVITA (Tangshan) Biological Technology Co., Ltd. | Commercial: 2019-nCoV Neutralizing Antibody Test (Quantum Dot Immunofluorescence Chromatography) | Device ID: 2531 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd | Commercial: 2019-nCoV Neutralizing Antibody Test Kit (Colloid Gold Immunoassay) | Device ID: 1879 | Method: Immunoassay | 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) | Device ID: 1811 | 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) | Device ID: 1812 | Method: Immunochromatography | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Hangzhou Matridx Biotechnology Co., Ltd | Commercial: 2019-nCov Rapid Test Kit | Device ID: 214 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd | Commercial: 39501-Recombinant SARS-CoV-2 Nucleocapsid Protein | Device ID: 605 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd | Commercial: 39502-Recombinant SARS-CoV-2 Spike Protein | Device ID: 606 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd | Commercial: 39503-Recombinant SARS-CoV-2 Spike (R682S) Protein | Device ID: 607 | 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