| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Mikrogen Diagnostik | Commercial: ampliCube Coronavirus Panel | Device ID: 282 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mokobio Biotechnology R&D Center | Commercial: SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay | Device ID: 285 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd | Commercial: PathoCatch COVID-19 Qualitative PCR Kit | Device ID: 288 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nal von minden GmbH | Commercial: NADAL COVID-19 IgG/IgM Test (243003N-25 and 243001N-10) | Device ID: 289 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Vazyme Medical Technology Co., Ltd | Commercial: 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit | Device ID: 291 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Next Pharma Inc | Commercial: DiaCarta's QuantiVirusTMSARS-CoV-2 Test | Device ID: 295 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genesig | Commercial: genesig Real-Time PCR COVID-19 | Device ID: 301 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: OSANG Healthcare Co., Ltd | Commercial: GeneFinder COVID-19 RealAmp Kit | Device ID: 304 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc | Commercial: PCL COVID19 IgG/IgM Rapid Gold | Device ID: 307 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc | Commercial: PCL COVID19 Ag Rapid FIA | Device ID: 308 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PEPperPRINT GmbH | Commercial: PEPperCHIP SARS-CoV-2 Proteome Microarray (manual) | Device ID: 309 | Method: Other | Target: Other | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: PerGrande BioTech Development Co., Ltd | Commercial: SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay) | Device ID: 310 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PerkinElmer Inc | Commercial: PerkinElmer SARS-CoV-2 Realtime RT-PCR Assay | Device ID: 311 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PRIMA Lab | Commercial: PRIMA COVID-19 IgG/IgM Rapid Test (For Professional Use) | Device ID: 318 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Progenie Molecular S.L.U. | Commercial: RealCycler CORO | Device ID: 322 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: QIAGEN GmbH | Commercial: QIAstat-Dx Respiratory Panel 2019-nCoV | Device ID: 324 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co., Ltd | Commercial: Hightop COVID-19 IgM/IgG Ab Rapid Test Kit | Device ID: 325 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Quidel Corporation | Commercial: Lyra SARS-CoV-2 Assay | Device ID: 331 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BioVendor | Commercial: BIOCREDIT COVID-19 Ag | Device ID: 335 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RapiGEN Inc | Commercial: BIOCREDIT COVID-19 IgG+IgM Duo | Device ID: 336 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RayBiotech | Commercial: Coronavirus (SARS-CoV-2) IgM/IgG Test Kit (Colloidal Gold) | Device ID: 337 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ROCHE Diagnostics | Commercial: cobas SARS-CoV-2 (for use on the cobas 6800/8800 Systems) | Device ID: 339 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Sansure Biotech, Inc | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Device ID: 342 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc | Commercial: STANDARD M nCoV Real-Time Detection Kit | Device ID: 343 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc | Commercial: STANDARD F COVID-19 Ag FIA | Device ID: 344 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc | Commercial: STANDARD Q COVID-19 Ag Test | Device ID: 345 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc | Commercial: STANDARD Q COVID-19 IgM/IgG Duo Test | Device ID: 346 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SEASUN BIOMATERIALS | Commercial: U-TOP COVID-19 Detection Kit | Device ID: 347 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Seegene, Inc | Commercial: Allplex 2019-nCoV assay | Device ID: 348 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sensing Self Pte., Ltd | Commercial: EDR COVID 19 Rapid Test Kit (IgM/IgG) | Device ID: 351 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sente Biolab | Commercial: Senteligo Covid-19 qRT PCR Detection Kit | Device ID: 352 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sentinel CH | Commercial: STAT-NAT Covid-19 HK | Device ID: 353 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: servoprax GmbH | Commercial: Cleartest Corona, Covid-19 | Device ID: 354 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shaanxi Lifegen Co., Ltd | Commercial: Novel coronavirus (COVID-19) nucleic acid detection kit (fluorescent PCR method) | Device ID: 355 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd | Commercial: 2019-nCoV IgM Antibody Diagnostic Kit (Colloidal gold) | Device ID: 357 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Rendu Biotechnology Co., Ltd | Commercial: AmpSure 2019-nCov RNA Assay | Device ID: 362 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Bioeasy Biotechnology Co., Ltd | Commercial: Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence) | Device ID: 365 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co., Ltd | Commercial: MAGLUMI 2019-nCoV IgG (CLIA) | Device ID: 374 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co., Ltd | Commercial: MAGLUMI 2019-nCoV IgM (CLIA) | Device ID: 375 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Solgent Co., Ltd | Commercial: DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit | Device ID: 376 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Sugentech, Inc | Commercial: SGTi-flex COVID-19 IgM/IgG (RDT) | Device ID: 388 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co., Ltd | Commercial: SARS-CoV-2 IgM/IgG Ab Rapid Test | Device ID: 390 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co., Ltd | Commercial: SARS-CoV-2 IgM Ab Rapid Test | Device ID: 391 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co., Ltd | Commercial: SARS-CoV-2 IgG Ab Rapid Test | Device ID: 392 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Systaaq Diagnostic Prouducts | Commercial: 2019-Novel Coronavirus (COVID-19) Real Time PCR Kit | Device ID: 395 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tianjin MNCHIP Technologies Co., Ltd | Commercial: Anti-COVID-19 virus IgM/IgG rapid test kit (Colloidal gold assay) | Device ID: 404 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: SARS-CoV-2 E, RdRP or N gene CE-IVD 7 virus Respiratory Panel multiplex RT-PCR | Device ID: 406 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd | Commercial: EasyNAT Integrated, Automated Molecular Diagnostic Assay for COVID-19 RNA | Device ID: 418 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Veredus Laboratories Pte Ltd | Commercial: VereCoV OneMix Detection Kit for VerePLEX Biosystem | Device ID: 419 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Vircell S.L. | Commercial: COVID-19 VIRCLIA IgG MONOTEST | Device ID: 422 | Method: Immunoassay | Target: Antibody, IgG | 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