| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Labgenomics Co. Ltd. | Commercial: LabGun COVID-19 Assay plus | Device ID: 2353 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Labgenomics Co. Ltd. | Commercial: LabGun COVID-19 RT-PCR Kit | Device ID: 2352 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Labgenomics Co. Ltd. | Commercial: LabGun COVID-19 ExoFast RT-PCR Kit | Device ID: 2351 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: ECOTEST COVID-19 Antigen Rapid Test Device (Nasopharyngeal swab, Oropharyngeal swab) | Device ID: 2350 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NATRIX S.R.L. | Commercial: KIT REVOLUTION COVID-19 RAPID SALIVARY TEST FOR SARS-COV-2 | Device ID: 2349 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NATRIX S.R.L. | Commercial: KIT REVOLUTION COVID-19 ANTIGENIC TEST FOR SARS-COV-2 | Device ID: 2348 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | 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: 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: 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: Mylab Discovery Solutions Pvt. Ltd. | Commercial: CoviSelf COVID-19 Antigen Lateral Flow Test Device OTC Home Test | Device ID: 2343 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: LumiraDx UK Ltd. | Commercial: LumiraDx SARS-COV-2 Antigen Pool Test | Device ID: 2342 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience Co. Ltd. | Commercial: SARS-CoV-2 Neutralization Antibody Rapid Test Kit | Device ID: 2341 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience Co. Ltd. | Commercial: Flu A/B + COVID-19 Antigen Combo Test Cassette Kit | Device ID: 2340 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience Co. Ltd. | Commercial: SARS-CoV-2 Total Antibody Rapid Test Kit | Device ID: 2339 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience Co. Ltd. | Commercial: SARS-CoV-2 Neutralization Antibody Test Kit (ELISA) | Device ID: 2338 | Method: ELISA | Target: Antibody | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience Co. Ltd. | Commercial: SARS-CoV-2 Total Antibody Test Kit (ELISA) | Device ID: 2337 | Method: ELISA | Target: Antibody | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: VIDIA spol. s r.o. | Commercial: Rapid-VIDITEST anti- SARS-CoV-2 IgG/IgM | Device ID: 2336 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Attana AB | Commercial: Attana AVA SARS-CoV-2 IgG Immunoassay | Device ID: 2335 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: VIDIA spol. s r.o. | Commercial: Rapid-VIDITEST anti- SARS-CoV-2 (RBD) IgG | Device ID: 2334 | Method: Immunochromatography | Target: IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Yilifang Biotech Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Colloidal Gold) | Device ID: 2333 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co. Ltd. | Commercial: Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva) | Device ID: 2332 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co. Ltd. | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 2331 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19/Influenza A/Influenza B Detection Kit | Device ID: 2330 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience Co. Ltd. | Commercial: SARS-CoV-2 IgM-IgG-IgA Combined Antibody Rapid Test Kit | Device ID: 2329 | Method: Immunochromatography | Target: Antibody, IgA, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Sigmed Sp. z o.o. | Commercial: Redtest SARS-CoV-2 Antigen Rapid Test (Covid-19 Ag) | Device ID: 2328 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 S-RBD IgG Antibody Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2327 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Beier Bioengineering Co. Ltd. | Commercial: COVID-19 ANTIGEN RAPID TEST KIT | Device ID: 2326 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab) | Device ID: 2325 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: GSD NovaLisa® SARS-CoV-2 (COVID-19) quantitative IgG | Device ID: 2324 | Method: Immunoassay | Target: IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Roche (SD BIOSENSOR) | Commercial: SARS-CoV-2 Antigen Self Test Nasal | Device ID: 2323 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: 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: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Ag Lateral Flow Test Device | Device ID: 2320 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: CVAG4080A – GSD NovaGen SARS-CoV-2 Ag Rapid Test (NP Swab) | Device ID: 2319 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEDICE Arzneimittel Pütter GmbH & Co. KG | Commercial: Medicovid-AG SARS-CoV-2 Antigen Selbsttest-Nase | Device ID: 2318 | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Immuno Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 2317 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab) | Device ID: 2316 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BBB Inc. | Commercial: MARK-B COVID-19 Ag | Device ID: 2315 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19/Influenza A+B Ag Combo Rapid Test (Colloidal Gold) | Device ID: 2314 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19 Ag Rapid Test (Colloidal Gold) | Device ID: 2313 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19 (SARS-CoV-2) IgM/IgG Antibody Rapid Test Kit (Colloidal Gold) | Device ID: 2312 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Diagnostic Kit (Colloidal Gold) | Device ID: 2311 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Hongyu Medical Commodity Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Multiple Detection Kit | Device ID: 2310 | Method: Immunochromatography | Target: Antibody, IgG | Format: Manual, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Hongyu Medical Commodity Co. Ltd. | Commercial: SARS-CoV-2 Ag Rapid Test Kit | Device ID: 2309 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19/Influenza A+B/RSV/ADV Antigen Combo Rapid Test (Colloidal Gold) | Device ID: 2308 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19/Influenza A+B/RSV Antigen Combo Rapid Test (Colloidal Gold) | Device ID: 2307 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19 Antibody Detection Kit | Device ID: 2306 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Detection Kit | Device ID: 2305 | Method: Immunoassay | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Lituo Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit (Colloidal Gold) | Device ID: 2304 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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