| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Reagens Ltd. | Commercial: Cov2Quant™ SARS-CoV-2 Quantification Kit | Device ID: 2367 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Laipac Technology Inc. | Commercial: LooK SPOT 2 | Device ID: 2368 | Method: Immunoassay | Target: Antigen | Format: Automated, Other | Go to details |
| CE Marking: Yes | Manufacturer: CerTest Biotec S.L | Commercial: VIASURE SARS-CoV-2 & UK Variant (S UK, ORF1ab and N genes) Real Time PCR Detection Kit | Device ID: 2369 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: CerTest Biotec S.L | Commercial: VIASURE SARS-CoV-2 Variant I Real Time PCR Detection Kit | Device ID: 2370 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: CerTest Biotec S.L | Commercial: VIASURE SARS-CoV-2 Variant II Real Time PCR Detection Kit | Device ID: 2371 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Reagens Ltd. | Commercial: Inf-Cov2Quant™ Influenza A/B + SARS-CoV-2 Quantification Kit | Device ID: 2372 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nal von minden GmbH | Commercial: dedicio® COVID-19 Ag pro Test | Device ID: 2373 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Abioteq GmbH | Commercial: Cora Gentest-19 | Device ID: 2374 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Anhui Hua Pei Biotechnology Co. Ltd. | Commercial: COVID-19 Virus Antigen Detection Kit（Fluorescence Immunochromatography Assay） | Device ID: 2375 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Neomedica d.o.o. | Commercial: NAISSA SARS-COV-2 S1/S2/RBD Neutralizing antibodies | Device ID: 2377 | Method: ELISA | Target: Antibody, IgG | Format: 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: BioSpeedia International | Commercial: BioSpeedia COVID19 Non-Invasive Antigen Test BSD_504 | Device ID: 2379 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioSpeedia International | Commercial: COVID19Speed-Antigen Test BSD_0503 | Device ID: 2380 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioSpeedia International | Commercial: BioSpeedia COVID19 Nasal Antigen Test BSD_506 | Device ID: 2381 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc. | Commercial: Dia Sure COVID-19 Antigen Rapid Test Device | Device ID: 2382 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MedMira Laboratories Inc. | Commercial: REVEALCOVID-19(TM) Total Antibody Test | Device ID: 2383 | Method: Immunoassay | Target: Antibody, IgA, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 Antigen Rapid Test (Oral Fluid) | Device ID: 2386 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 Antigen Rapid Test(Nasopharyngeal Swab) | Device ID: 2387 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 Antigen Test Cassette (Nasopharyngeal Swab)(FIA) | Device ID: 2388 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) | Device ID: 2389 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 2390 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 2391 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 2392 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2393 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2394 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2395 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 2396 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 2397 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: ichroma™ COVID-19 nAb | Device ID: 2398 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: AFIAS COVID-19 nAb | Device ID: 2399 | Method: Immunoassay | Target: Antibody | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2400 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 2401 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test (Swab)(NP) | Device ID: 2402 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2403 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2404 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoDetect COVID-19 Qualitative PCR Kit (Compatible with the Automated Extraction System- COMPACT X/XL) | Device ID: 2406 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: mosaiques diagnostics GmbH | Commercial: DiaPat-CoV-50 | Device ID: 2407 | Method: Other | Target: | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Antigen Lateral Flow Test Device | Device ID: 2408 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 2409 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 2410 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 2411 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2412 | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: Boditech Quick™ COIVD-19 Ag | Device ID: 2413 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Huian Biosci Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2414 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Dymind Biotechnology Co. Ltd. | Commercial: Sars-CoV-2 antigen test kit (colloidal gold) | Device ID: 2415 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2416 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) | Device ID: 2417 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Dymind Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 antigen test kit (Saliva sample) | Device ID: 2418 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: Rapid SARS-CoV-2 Antigen Test (nasopharyngeal specimen) | Device ID: 2419 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 and M.pneumoniae IgG Combo Rapid Test (Whole Blood/Serum/Plasma) Package Insert | Device ID: 2420 | Method: Immunoassay | Target: Antibody, IgG | 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