| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: 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 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 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: Yes | Manufacturer: Guangzhou Wondfo Biotech Co., Ltd | Commercial: Finecare SARS-CoV-2 Antibody Test | Device ID: 206 | 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: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Device ID: 208 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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: Yes | Manufacturer: Hangzhou Biotest Biotech Co., Ltd | Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 212 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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 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: Yes | Manufacturer: Hibergene | Commercial: Hibergene (lab-based or near-POC) | Device ID: 216 | Method: LAMP | Target: Nucleic acid | Format: Lab-based | 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 |
| CE Marking: Yes | Manufacturer: Hong Kong University of Science and Technology | Commercial: On-site rapid molecular diagnostic system based on Shenzhen Shineway Technology | Device ID: 218 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Humasis | Commercial: Humasis COVID-19 IgG/IgM Test | Device ID: 219 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Lituo Biotechnology Co., Ltd | Commercial: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Device ID: 220 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Hunan Yonghe-Sun Biotechnology Co., Ltd | Commercial: SARS-COV-2 specific antibody test kit (Immunochromatography) | Device ID: 221 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Huwel Lifesciences Pvt. Ltd | Commercial: Quantiplus CORONA Virus (2019nCoV) detection kit | Device ID: 222 | Method: RT-PCR | 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: InBios International | Commercial: InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit | Device ID: 224 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: InDevR Inc | Commercial: COVID Serology Kit: Multiplexed Immunoassay | Device ID: 225 | Method: Immunoassay | Target: Antibody | 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: Yes | Manufacturer: INNOVITA (Tangshan) Biological Technology Co., Ltd. | Commercial: 2019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/Serum/Plasma Combo) | Device ID: 227 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products, Inc | Commercial: Rapid SARS-CoV-2 Antibody Test | Device ID: 228 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products, Inc | Commercial: Rapid SARS-CoV-2 Antibody (IgM/IgG) | Device ID: 229 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Integrated DNA Technologies/Danaher | Commercial: SARS-CoV-2 (2019-nCoV) CDC qPCR Probe Assay | Device ID: 231 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: Jiangsu Bioperfectus Technologies Co. Ltd | Commercial: PerfectQ COVID-19 Coronavirus Real Time PCR Kit | Device ID: 234 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd | Commercial: Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit | Device ID: 236 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Microdiag Biomedicine Technology Co., Ltd | Commercial: Detection of 2019 novel coronavirus (2019-nCoV) by LFD RT-RAA | Device ID: 237 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: Jiangsu Qitian Gene Biotechnology Co., Ltd | Commercial: Fluorescent RAA Detection for 2019-nCoV | Device ID: 239 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Superbio Biomedical Technology (Nanjing) Co., Ltd | Commercial: Fast SARS-CoV-2 lgM/lgG Antibody Detection Kit (Colloidal Gold) | Device ID: 240 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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: 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 Antigen Detection Rapid Test | Device ID: 244 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: KH Medical Co. Ltd | Commercial: RADI COVID-19 Detection Kit and RADI COVID-19 Triple Detection Kit | Device ID: 245 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Kogene Biotech | Commercial: PowerChek 2019-nCoV Real-time PCR Kit | Device ID: 246 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) IgM Rapid Test | Device ID: 247 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) IgG/IgM Rapid Test | Device ID: 248 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) Nucleocapsid Protein IgG ELISA (manual) | Device ID: 249 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: KRISHGEN BioSystems | Commercial: SARS-CoV-2 (Covid-19) Real-Time PCR Kit (as per CDC Atlanta guidelines) | Device ID: 250 | 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