| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience Co. Ltd. | Commercial: A Rapid IgM-IgG Combined Antibody Test Kit for SARS-Cov-2-(ICA) | Device ID: 1645 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: A&B Professional | Commercial: A&B RAPID TEST COVID-19 IGG/IGM CASSETTA | Device ID: 1004 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: A*ccelerate | Commercial: A*STAR Fortitude Kit 2.0 | Device ID: 504 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: A*ccelerate | Commercial: A*STAR Fortitude Kit 2.0 (Singapore HSA) – PCR kit | Device ID: 13 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Abbott | Commercial: Abbott ID NOW COVID-19 | Device ID: 496 | Method: Other | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Abbott Molecular Inc. | Commercial: Abbott RealTime SARS-CoV-2 | Device ID: 1041 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Abbott | Commercial: ABBOTT REALTIME SARS-COV-2 ASSAY | Device ID: 876 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Abbott | Commercial: Abbott RealTime SARS-CoV-2 EUA test | Device ID: 8 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Abingdon Health Plc | Commercial: AbC-19 Rapid Test | Device ID: 1992 | Method: Immunoassay | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Abingdon Health Plc | Commercial: AbC-19 Semi-Q Rapid Test | Device ID: 2879 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: abCyclerQd Realâ€time PCR System | Commercial: abCyclerQd Real‐time PCR System | Device ID: 3132 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: AB Dianostic Systems GmbH | Commercial: abia SARS-CoV- IgG/IgM | Device ID: 913 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: AB Dianostic Systems GmbH | Commercial: abia SARS-CoV-2 Ab | Device ID: 505 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 Ag | Device ID: 1982 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 Ag Rapid | Device ID: 1981 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 IgM/IgG Combo | Device ID: 1302 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 IgM/IgG Rapid | Device ID: 1151 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 NAb | Device ID: 1983 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: No | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 NAb & TAb | Device ID: 1984 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: No | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 NAb Rapid | Device ID: 1985 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AITbiotech | Commercial: abTES COVID-19 qPCR I Kit | Device ID: 468 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: AITBIOTECH PTE Ltd. | Commercial: abTES COVID-19 Variant qPCR I Kit | Device ID: 3119 | Method: RT-PCR | Target: | Format: Automated, Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: AITBIOTECH PTE Ltd. | Commercial: abTES Qd Sample Preparation Kit | Device ID: 3130 | Method: RT-PCR | Target: Other | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AITBIOTECH PTE Ltd. | Commercial: abTES™ Flu/COVID-19 qPCR I Kit | Device ID: 3129 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: AITbiotech | Commercial: abTES™ Qd COVID‐19 qPCR I Kit | Device ID: 3131 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: JIAXING WISETEST BIO-TECH Co. Ltd. | Commercial: ABtex AG | Device ID: 2528 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: AcouSort | Commercial: AB Blood plasma separation using ultrasound | Device ID: 649 | Method: Other | Target: Other | Format: Other | 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: Beckman Coulter | Commercial: ACCESS SARS-CoV-2 IgG | Device ID: 2996 | Method: CLIA | Target: IgG | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Beckman Coulter | Commercial: ACCESS SARS-CoV-2 IgG (1st IS) | Device ID: 2994 | Method: CLIA | Target: IgG | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Beckman Coulter | Commercial: ACCESS SARS-CoV-2 IgG II | Device ID: 2995 | Method: CLIA | Target: IgG | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Beckman Coulter | Commercial: ACCESS SARS-CoV-2 IgM | Device ID: 2997 | Method: CLIA | Target: IgM | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: Accu-Tell COVID-19 Antigen Cassette (Nasal Swab) | Device ID: 2578 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: Accu-Tell COVID-19 Antigen Cassette (Saliva) | Device ID: 2580 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: Accu-Tell COVID-19 IgG/IgM Cassette | Device ID: 14 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: Accu-Tell SARS-CoV-2 Ag Cassette | Device ID: 2579 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: ACCU-TELL® SARS-CoV-2 Neutralizing Antibody Cassette | Device ID: 2581 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Diagnostic Automation/Cortez Diagnostics Inc. | Commercial: Accudiag SCoV-2 IgG ELISA | Device ID: 1307 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diagnostic Automation/Cortez Diagnostics Inc. | Commercial: Accudiag SCoV-2 IgM ELISA Kit | Device ID: 1193 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Mesa Biotech | Commercial: Accula SARS-CoV-2 test | Device ID: 736 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BIONEER Corporation | Commercial: AccuPower COVID-19 Real-Time RT-PCR kit (lab-based automated kit: NCV-1111) | Device ID: 527 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BIONEER Corporation | Commercial: AccuPower SARS-CoV-2 Real-Time RT-PCR kit (manual kit: SCV-2122) | Device ID: 528 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Eachy Biopharmaceuticals | Commercial: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) | Device ID: 671 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genomictree Inc. | Commercial: AccuraTect RT-qPCR SARS-CoV-2 | Device ID: 187 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Accuster Technologies Pvt Ltd. | Commercial: Accuster SARS-COV2-RT-PCR test kit | Device ID: 763 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: ACE2 antibody [N1N2], N-term (GTX101395) | Device ID: 557 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: ACE2-RBD Neutralization Assay | Device ID: 2462 | Method: ELISA | Target: IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories Inc. | Commercial: ACON SARS-CoV-2 IgG/IgM Rapid Test | Device ID: 1675 | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AIDIAN | Commercial: Acro 2019-nCoV IgG/IgM pikatesti | Device ID: 994 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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