| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Quantitative Test (Fluorescence Immunochromatography)-Blood | Device ID: 2693 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Method) | Device ID: 2230 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography) | Device ID: 1286 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method) | Device ID: 87 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOLAN HEALTH S.L. | Commercial: COVID-19 Antigen Rapid Test (Colloidal Gold Method) | Device ID: 2519 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOLAN HEALTH S.L. | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 1829 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biolidics | Commercial: 2019-nCoV IgG/IgM Antibody Detection Kit | Device ID: 497 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BiologyWorks Inc. | Commercial: BiologyWorks | Device ID: 2744 | Method: LAMP | Target: | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioMARIC | Commercial: SARS-CoV-2 Total Ab ELISA | Device ID: 2639 | Method: ELISA | Target: Antibody | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: BioMaxima SA | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Device ID: 88 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioMaxima SA | Commercial: COVID-19 Antigen Rapid Test | Device ID: 2036 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioMaxima SA | Commercial: SARS-CoV-2 Ag Rapid Test | Device ID: 2035 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioMaxima SA | Commercial: SARS-CoV-2 Real Time PCR LAB-KIT | Device ID: 89 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: bioMérieux SA | Commercial: ARGENE COVID-19 R-GENE | Device ID: 2681 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: bioMérieux SA | Commercial: BIOFIRE Respiratory Panel 2.1 (RP2.1) | Device ID: 94 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: bioMérieux SA | Commercial: SARS-COV-2 R-GENE (ref 432720) | Device ID: 526 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: bioMérieux SA | Commercial: SARS-COV-2 RESPI R-GENE | Device ID: 2004 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: bioMérieux SA | Commercial: VIDAS SARS-COV-2 IgG | Device ID: 881 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: bioMérieux SA | Commercial: VIDAS SARS-COV-2 IgM | Device ID: 957 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: BioMedomics Inc. | Commercial: COVID-19 IgM/IgG Rapid Test | Device ID: 90 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioMedomics Inc. | Commercial: SARS-CoV-2 Antigen Test Kit (LFIA) | Device ID: 2520 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Biomeme | Commercial: 10 Minutes COVID-19 IgG/IgM Rapid Test | Device ID: 92 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Biomeme | Commercial: COVID-19 Go Strips | Device ID: 91 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Biomerica Inc. | Commercial: Biomerica COVID-19 Antigen Rapid Test (nasopharyngeal swab) | Device ID: 1599 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biomerica Inc. | Commercial: Biomerica COVID-19 IgG/IgM Rapid Strip Test (1507B) | Device ID: 1603 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biomerica Inc. | Commercial: Biomerica COVID-19 IgG/IgM Rapid Test (1507A) | Device ID: 1601 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: bioMerieux | Commercial: ARGENE COVID-19 R-GENE | Device ID: 2757 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: bioMerieux | Commercial: BioFire® Respiratory 2.1plus Panel | Device ID: 1804 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: BioMol Laboratories srl | Commercial: INFET-002-100 SARS-COV-2 RT-PCR KIT VIRAL 3 | Device ID: 2361 | Method: RT-PCR | Target: | Format: Lab-based, Manual, Semi-automated | 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: BIONEER Corporation | Commercial: SCVR-2122 AccuPower SARS-CoV-2 Real-Time RT-PCR Kit (50 tests) | Device ID: 529 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bioneovan Co. Ltd. | Commercial: Bioneovan COVID-19 Antigen Test Kit (Colloidal Gold) | Device ID: 2077 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioneovan Co. Ltd. | Commercial: COVID-19 IgG Antibody Test Kit (Colloidal Gold) | Device ID: 2206 | Method: Immunochromatography | Target: IgG | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioneovan Co. Ltd. | Commercial: COVID-19 IgM Antibody Test Kit (Colloidal Gold) | Device ID: 2208 | Method: Immunochromatography | Target: IgM | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioneovan Co. Ltd. | Commercial: COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold) | Device ID: 2207 | Method: Immunochromatography | Target: IgG, IgM | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioneovan Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Test Kit (Colloidal Gold) | Device ID: 2205 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bionote Inc. | Commercial: NowCheck COVID-19 Ag Test | Device ID: 1242 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biopanda Reagents | Commercial: COVID-19 Rapid Antibody Test | Device ID: 1016 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biopanda Reagents | Commercial: COVID-19 Rapid Antigen Test | Device ID: 2034 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioperfectus Technologies Co. Ltd. (Jiangsu) | Commercial: COVID-19 Coronavirus Real Time PCR Kit | Device ID: 962 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: BioRad | Commercial: COVID-19 Droplet Digital PCR (ddPCR) Assay | Device ID: 755 | Method: Digital-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: BioRad | Commercial: Reliance One-Step RT-qPCR Supermix | Device ID: 757 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: BioRad | Commercial: SARS-CoV-2 / COVID-19 Assa | Device ID: 99 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: BioRad | Commercial: SARS-CoV-2 Negative | Device ID: 98 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: BioRad | Commercial: standard for SARS-CoV-2 | Device ID: 97 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: BioReference Laboratories | Commercial: Novel Coronavirus COVID-19 | Device ID: 100 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BIORON Diagnostics GmbH | Commercial: RealLine SARS CoV-2 | Device ID: 1460 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BIORON Diagnostics GmbH | Commercial: RealLine SARS-CoV-2 lyo REF VBD5580 | Device ID: 1459 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bioscience(Tianjin) Diagnostic Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Rapid Detection kit | Device ID: 2858 | Method: RT-PCR | 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