| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: GeneFirst Ltd. | Commercial: Respiratory Pathogen Panel | Device ID: 176 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: geneOmbio Technologies Pvt. Ltd. | Commercial: geneOmbio COVID-19 rt-LAMP test | Device ID: 178 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: General Biologicals Corporation | Commercial: GB SARS-CoV-2 Real Time RT-PCR | Device ID: 179 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: GeneReach Biotechnology Corporation | Commercial: POCKIT Central SARS-CoV-2 (orf 1ab) Premix Reagent | Device ID: 180 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | 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: Genesystem Co. Ltd. | Commercial: SMARTCHECK SARS-CoV2 Detection Kit | Device ID: 181 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: ACE2 antibody [N1N2], N-term (GTX101395) | Device ID: 557 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV / SARS-CoV-2 (COVID-19) nucleocapsid antibody [6H3] (GTX632269)_ELISA | Device ID: 558 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV / SARS-CoV-2 (COVID-19) spike antibody [1A9] (GTX632604) | Device ID: 559 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV-2 (COVID-19) nucleocapsid antibody (GTX135357)_ELISA | Device ID: 560 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV-2 (COVID-19) nucleocapsid protein (GTX135357-pro) | Device ID: 561 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: SARS-CoV-2 (COVID-19) spike antibody (GTX135360)_ELISA | Device ID: 562 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Genetic PCR Solutions | Commercial: GPS 2019-nCoV qPCR kit | Device ID: 896 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Genetic Signatures Limited | Commercial: EasyScreen Pan-Coronavirus/SARS-CoV-2 Detection Kit | Device ID: 182 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: GenMark Diagnostics | Commercial: ePlex SARS-CoV-2 Test | Device ID: 184 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: GenoSensor | Commercial: GS COVID-19 RT-PCR Kit | Device ID: 723 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: GenScript | Commercial: 2019-nCoV qRT-PCR Detection Assay | Device ID: 188 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: GenScript | Commercial: SARS-CoV-2 Spike S1-RBD IgG&IgM ELISA Detection Kit | Device ID: 1620 | Method: ELISA | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: GFE | Commercial: SARS-CoV-2 PCR Reagent Kit | Device ID: 822 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: GNA Biosolutions GmbH | Commercial: Sars-CoV-2 Detection Kit on portable PCA Analyzer | Device ID: 191 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Gnomegen | Commercial: Gnomegen COVID-19 RT-Digital PCR Detection Kit | Device ID: 724 | Method: Digital-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Guangdong Huayin Medicine Science Co. Ltd. | Commercial: Detection Kit for 2019-nCoV RNA (RT-PCR Fluorescence Probing) (Lyophilised) | Device ID: 194 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Guangdong Longsee Biomedical Co. Ltd. | Commercial: 2019-nCoV Ag & Influenza A/B Rapid Co-DetectionKit (Immuno-Chromatography) | Device ID: 1342 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangdong Longsee Biomedical Co. Ltd. | Commercial: 2019-nCoV Ag & Influenza AB Ag RapidCo-Detection Kit (Immuno-Chromatography) | Device ID: 1323 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangdong Longsee Biomedical Co. Ltd. | Commercial: 2019-nCoV Nucleic Acid Detection Kit (Q-PCR Method) | Device ID: 1057 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | 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: 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: Guangzhou Fenghua Bioengineering Co. Ltd. | Commercial: Combined Detection Kit for Novel Coronavirus (2019-nCoV) IgM/IgG Antibody | Device ID: 199 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangzhou FulenGen Co. Ltd. | Commercial: RT-qPCR based SARS-CoV-2 detection kit with SPRS (Spike-in Reference Standard) | Device ID: 200 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Guangzhou HEAS BioTech Co. Ltd. | Commercial: 2019 Novel Coronavirus (2019-nCoV) RNA ASSAY (PCR Fluorescent Probe Method) | Device ID: 201 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Hybribio Medicine Technology Ltd. | Commercial: Respiratory Virus (IFVa/b + COVID-19) Real-Time PCR Kit | Device ID: 202 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Supbio Biotechnologies Inc. | Commercial: Supbio SARS-CoV-2 (ORF1ab/N) (Nucleic Acid Detection Kit / PCR-Fluorescent) | Device ID: 203 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Tebsun Bio-Tech Development Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Test (LAMP) | Device ID: 204 | Method: LAMP | Target: Nucleic acid | Format: Automated, Lab-based, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Wondfo SARS-CoV-2 Nucleic Acid Detection Kit | Device ID: 205 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Hackensack Meridian Health CDI | Commercial: SARS-COV-2 test | Device ID: 207 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory | Commercial: CDI Enhanced COVID-19 Test | Device ID: 726 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Hain Lifescience a Bruker company | Commercial: FluoroType® SARS-CoV-2 evo | Device ID: 2972 | Method: RT-PCR | Target: | Format: Semi-automated | 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: 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: Hangzhou Bigfish Bio-tech Co. Ltd. | Commercial: The golden standard of SARS-CoV-2 viral nucleic acid detection | Device ID: 211 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Hangzhou Dan Wei Biotechnology Co. Ltd. | Commercial: 2019-nCoV Direct RT-qPCR Kit | Device ID: 213 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Hangzhou Singclean Medical Products Co. Ltd. | Commercial: COVID-19 IgG/IgM Combined Test kit(Colloidal Gold Method) | Device ID: 995 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: 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: Hangzhou Testsea Biotechnology Co. Ltd. | Commercial: One Step SARS-nCoV2 (COVID-19) IgG/IgM test | Device ID: 676 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Healgen Scientific | Commercial: Rapid COVID-19 AntigenTest | Device ID: 1612 | Method: CLIA | Target: Antigen | Format: | Go to details |
| CE Marking: No | Manufacturer: Hologic | Commercial: Panther Fusion SARS-CoV-2 assay | Device ID: 217 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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