| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Guangzhou Hybribio Medicine Technology Ltd | Commercial: Respiratory Virus (IFVa/b + COVID-19) Real-Time PCR Kit | 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) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Fenghua Bioengineering , Co. LTD | Commercial: Combined Detection Kit for Novel Coronavirus (2019-nCoV) IgM/IgG Antibody | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: V-CHEK, 2019-nCoV Ag Rapid Test Kit (Immunochromatography) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: V-CHEK, 2019-nCoV Ag Rapid Test Kit (Fluorescence Immunochromatographic Assay) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: V-CHEK, 2019-nCoV Ag Rapid Test Card (Immunochromatography) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: V-CHEK, 2019-nCoV Ag & FLU A/B Combo Rapid | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: V-CHEK SARS-CoV-2 Ag Rapid Test Kit | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: V-CHEK 2019-nCoV Ag Rapid Test Kit | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: V-CHEK 2019-nCoV Ag & FLU A/B Combo Rapid Test | Method: Immunoassay | Target: Antigen | 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) | 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 IgG Antibody Detection Kit (Colloidal Gold Method) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Darui Biotechnology Co.,Ltd | Commercial: 2019 Novel Coronavirus (2019-nCoV) IgM Antibody Detection Kit (ELISA Method) | 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) IgG Antibody Detection Kit (ELISA Method) | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co., Ltd. | Commercial: COVID-19 Neutralizing Antibody Test Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co., Ltd | Commercial: Flu+COVID-19 Ag Test Kit | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co., Ltd | Commercial: COVID-19 Ag Test Kit | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co., Ltd | Commercial: Coronavirus COVID-19 lgM/IgG Test Kit (colloidal) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co., Ltd | Commercial: Coronavirus COVID-19 IgM/IgG Test Kit | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Longsee Biomedical Co., Ltd | Commercial: COVID-19 Ag Rapid Test Kit (Immuno-Chromatography) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Longsee Biomedical Co., Ltd | Commercial: 2019-nCoV Nucleic Acid Detection Kit (RT-IMSA Method) | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Guangdong Longsee Biomedical Co., Ltd | Commercial: 2019-nCoV Nucleic Acid Detection Kit (Q-PCR Method) | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Guangdong Longsee Biomedical Co., Ltd | Commercial: 2019-nCoV Ag & Influenza AB Ag RapidCo-Detection Kit (Immuno-Chromatography) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangdong Longsee Biomedical Co., Ltd | Commercial: 2019-nCoV Ag & Influenza A/B Rapid Co-DetectionKit (Immuno-Chromatography) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: COVID-19 IgG Antibody Test Kit (colloidal gold method) | Method: Immunoassay | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV/IAV/IBV Nucleic Acid Test Kit (PCR- fluorescence probe method) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV/IAV/IBV Antigen Test Kit (colloidal gold method) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV Nucleic Acid Test Kit (PCR- fluorescence probe method) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: 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 IgM/IgG Antibody Test Kit (colloidal gold method) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV Antigen Test Kit (colloidal gold method) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Green Cross Medical Science Corp. | Commercial: GENEDIA W ONE COVID 19 IgM&IgG | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Green Cross Medical Science Corp. | Commercial: GENEDIA W COVID-19 Real Time RT-PCR kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Green Cross Medical Science Corp. | Commercial: GENEDIA W COVID-19 Colorimetric LAMP premix kit | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Green Cross Medical Science Corp. | Commercial: GENEDIA W COVID-19 Ag | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Great Basin – Vela Operations | Commercial: SARS-CoV-2 Direct Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Goldsite Diagnostics Inc. | Commercial: SARS-CoV-2 Real-time RT-PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Goldsite Diagnostics Inc | Commercial: SARS-CoV-2 IgG/IgM Kit (manual) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Goldsite Diagnostics Inc | Commercial: SARS-CoV-2 Antigen Kit (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Gnomegen | Commercial: Gnomegen COVID-19 RT-Digital PCR Detection Kit | Method: Digital-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 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: GFE | Commercial: SARS-CoV-2 PCR Reagent Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech, Inc. | Commercial: SARS-CoV-2 Antigen (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech, Inc | Commercial: One Step Test for Novel Coronavirus(2019-nCoV) IgM/IgG antibody (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech, Inc | Commercial: Novel Coronavirus Real Time PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech, Inc | Commercial: Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: gerbion GmbH & Co., | Commercial: KG virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0 | 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