| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Pishtaz Teb Diagnostics | Commercial: SARS-CoV-2 IgG ELISA | Device ID: 596 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pishtaz Teb Diagnostics | Commercial: SARS-CoV-2 IgM ELISA Kit | Device ID: 597 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: PlexBio Co. Ltd. | Commercial: IntelliPlex SARS-CoV-2 Detection Kit | Device ID: 1408 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: PlexBio Co. Ltd. | Commercial: PlexBio CoVid19/SARS/Influenza A, B Detection kit | Device ID: 313 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Plexense Inc. | Commercial: ACCEL ELISA COVID-19 kit | Device ID: 2005 | Method: ELISA | Target: Antibody, IgA, IgG, IgM | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Plexense Inc. | Commercial: ACCEL ELISA COVID-19 Saliva Antigen Kit | Device ID: 2378 | Method: ELISA | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Polonord Adeste Srl | Commercial: POLOFLUOR 2 | Device ID: 2583 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: POLY-DETECH RAPIDTECH | Commercial: SARS-CoV-2 antigen rapid test | Device ID: 2483 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: No | Manufacturer: Prantae Solutions Pte Ltd. | Commercial: EyeRa-Covid | Device ID: 314 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Precision Biomonitoring Inc. | Commercial: TripleLock SARS-CoV-2 Test | Device ID: 2618 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Precision Biosensor | Commercial: Exdia COVID-19 Ag | Device ID: 1271 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Precision Biosensor | Commercial: PBCheck COVID-19 Ag | Device ID: 2467 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Predigen Inc. | Commercial: HR-PreV | Device ID: 315 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PREMIER MEDICAL CORPORATION PRIVATE LIMITED | Commercial: SURE STATUS COVID-19 ANTIGEN CARD TEST | Device ID: 2299 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: PREMIER MEDICAL CORPORATION PRIVATE LIMITED | Commercial: SureStatus COVID-19 (SARS-CoV-2) Card Test | Device ID: 317 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: PREMIER MEDICAL CORPORATION PRIVATE LIMITED | Commercial: SureStatus COVID-19 (SARS-CoV-2) EIA Test | Device ID: 316 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics UK Ltd. | Commercial: 2019-nCoV Antigen Device | Device ID: 1202 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics UK Ltd. | Commercial: 2019-nCoV Antigen Device (Anterior Nasal Swab) | Device ID: 2570 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics UK Ltd. | Commercial: 2019-nCoV IgG/IgM Rapid Test | Device ID: 1070 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics UK Ltd. | Commercial: 2019-nCoV Neutralising Antibody | Device ID: 2227 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics UK Ltd. | Commercial: COVID-19 Lyophilised Nucleic Acid Kit | Device ID: 1075 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: PRIMA Lab SA | Commercial: COVID-19 Antigen Professional Rapid Test | Device ID: 2686 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PRIMA Lab SA | Commercial: COVID-19 Antigen Rapid Test | Device ID: 2685 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PRIMA Lab SA | Commercial: COVID-19 IgG Spike Self Test | Device ID: 1975 | Method: Immunochromatography | Target: IgG | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PRIMA Lab SA | Commercial: COVID-19 NEUTRALISING Ab RAPID TEST | Device ID: 1875 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PRIMA Lab SA | 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: PRIME4DIA Co. Ltd. | Commercial: P4DETECT COVID-19 Ag | Device ID: 321 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: PRIME4DIA Co. Ltd. | Commercial: P4DETECT COVID-19 IgM/IgG | Device ID: 320 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: PRIME4DIA Co. Ltd. | Commercial: P4DETECT COVID-19 SAg | Device ID: 319 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PRIME4DIA Co. Ltd. | Commercial: Q-Sens® COVID-19 Ag | Device ID: 3103 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Primer Design Limited | Commercial: PathFlow™ COVID-19 Rapid Antigen PRO | Device ID: 25543 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Primer Design Limited | Commercial: PathFlow™ COVID-19 Rapid Antigen PRO | Device ID: 2782 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Primerdesign Novacyt | Commercial: genesig(R) Coronavirus (COVID-19) Rt-PCR assay | Device ID: 1156 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pro-med (Beijing) Technology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Detection Kit (Colloidal Gold) | Device ID: 2482 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pro-med (Beijing) Technology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Detection Kit (Colloidal Gold) | Device ID: 2636 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pro-med (Beijing) Technology Co. Ltd. | Commercial: COVID-19 IgM/IgG Antibody Rapid Detection Kit（Colloidal Gold） | Device ID: 2486 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pro-med (Beijing) Technology Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Rapid Detection Kit（Colloidal Gold） | Device ID: 2485 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Procomcure Biotech GmbH | Commercial: PhoenixDx SARS-Cov-2 IVD | Device ID: 971 | Method: RT-PCR | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Procomcure Biotech GmbH | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 2080 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Proel Biotech Ltd. | Commercial: SARS-CoV-2 IgG antibody detection kit (ELISA) | Device ID: 1482 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Lab-based, Manual, Semi-automated | 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: Prognosis Biotech | Commercial: Bio-Shield 2019-nCoV IgG | Device ID: 1499 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Bio-Shield 2019-nCov IgM | Device ID: 1500 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Bio-Shield 2019-nCov Total Ig | Device ID: 1498 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Home Test COVID-19 Ag | Device ID: 3615 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Rapid test 2019-nCoV Total Ig | Device ID: 1496 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Rapid Test Ag 2019-nCov | Device ID: 1495 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prometheus Bio Inc. | Commercial: 2019-nCOV IgG/IgM Test Cassette (Whole blood/Serum/Plasma) | Device ID: 868 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Promis Diagnostics | Commercial: SensDtect RT-qPCR SARS CoV-2 | Device ID: 323 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Promoitalia Group SpA | Commercial: DROP-TECH | Device ID: 1733 | 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