| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag Pro SARS-CoV-2 Ag | Device ID: 2768 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GeneReach Biotechnology Corporation | Commercial: POCKIT™ Central SARS CoV 2 ( orf 1ab ) Premix Reagent | Device ID: 2767 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Changzhou Biowin Pharmaceutical Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) (For Nasal) | Device ID: 2766 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Lomina Superbio a.s. | Commercial: Lomina SARS-CoV-2 Antigen LTX test (saliva) | Device ID: 2765 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GeneReach Biotechnology Corporation | Commercial: taco™ Sample Storage Solution (For DNA/RNA use) | Device ID: 2764 | Method: | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: ScheBo Biotech | Commercial: ScheBo SARS CoV-2 Quick ANTIGEN (Colloidal Gold Method) | Device ID: 2763 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Surge Medical Inc. | Commercial: COVID-19 Neutralizing Antibody Test Kit | Device ID: 2762 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: ROCHE Diagnostics | Commercial: cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System | Device ID: 2761 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ROCHE Diagnostics | Commercial: cobas SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas Liat System | Device ID: 2760 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: Verino Pro SARS CoV 2 Ag Rapid Test （self test） | Device ID: 2759 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag Pro SARS-CoV-2 Ag Rapid Test (self-test) | Device ID: 2758 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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: DNA Diagnostic | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 2756 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: COVID-19 (SARS-CoV-2) Antigen Test Kit | Device ID: 2755 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test | Device ID: 2754 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lifotronic Technology Co. Ltd. | Commercial: SARS-CoV-2 IgG (Electrochemiluminescence Immunoassay) | Device ID: 2753 | Method: CLIA | Target: IgG | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: Genobio Pharmaceutical Co. Ltd. | Commercial: Virusee® SARS-CoV-2 Molecular Detection Kit (Real-time RT-PCR) | Device ID: 2752 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: SARS-CoV-2 NeutraLISA | Device ID: 2751 | Method: ELISA | Target: Antibody, IgA, IgG, IgM | Format: Automated, Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Deep Blue Medical Technology Co. Ltd. | Commercial: COVID-19 (SARS-CoV-2) Antigen Test Kit (self-testing) | Device ID: 2750 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Changzhou Biowin Pharmaceutical Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)（For Saliva)） | Device ID: 2749 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Institut VirionSerion GmbH | Commercial: SERION ELISA agile SARS-COV-2 IgM | Device ID: 2748 | Method: ELISA | Target: IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Institut VirionSerion GmbH | Commercial: SERION ELISA agile SARS-COV-2 IgA | Device ID: 2747 | Method: ELISA | Target: IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. | Commercial: CHECK UP SARS-COV-2 NASOPHARYNGEAL ANTIGEN TEST | Device ID: 2746 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Institut VirionSerion GmbH | Commercial: SERION ELISA agile SARS-COV-2 IgG | Device ID: 2745 | Method: ELISA | Target: IgG | Format: Automated, Manual | 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: EUROIMMUN AG | Commercial: Anti-SARS-CoV-2 QuantiVac ELISA (IgG) | Device ID: 2743 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan HealthCare Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2742 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: OSANG Healthcare Co. Ltd. | Commercial: GeneFinder™ COVID-19 Ag Plus Rapid Test | Device ID: 2741 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: SARS-CoV-2 Antigen Saliva Lolly Test | Device ID: 2740 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hibergene | Commercial: PCR Adapt COVID-19 | Device ID: 2739 | Method: RT-PCR | Target: | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Baicare(Tianjin) Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Real Time RT-PCR Kit | Device ID: 2738 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Healgen Scientific | Commercial: CLINITEST® Rapid COVID-19 Antigen Test | Device ID: 2737 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: ADTech Co. Ltd. | Commercial: ADTech COVID-19 Ag RAPID KIT | Device ID: 2736 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vision Biyoteknoloji Araştırma Geliştirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited Şirketi | Commercial: VISION COVID-19 AG RAPID TEST KIT | Device ID: 2734 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing North Institute of Biotechnology Co. Ltd. | Commercial: COVID-19 TEST RAPIDO ANTIGENE RICOV4 | Device ID: 2733 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: iRAPID SARS-CoV-2 QUANT “NEUTRALIZING” Ab | Device ID: 2732 | Method: Immunochromatography | Target: IgG | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: CHORUS SARS-CoV-2 SCREEN SERUM | Device ID: 2731 | Method: ELISA | Target: | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SARS-CoV-2 Neutralization Antibody Detection Kit | Device ID: 2730 | Method: | Target: Antibody | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun Instant COVID-19 Ag | Device ID: 2729 | Method: | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun Covid-19 Ag Test | Device ID: 2728 | Method: | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SARS-CoV-2 Neutralization Antibody Rapid (Immunofluorescence) | Device ID: 2727 | Method: Immunoassay | Target: Antibody | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SARS-CoV-2 Neutralization Antibody Rapid | Device ID: 2726 | Method: | Target: Antibody | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun Anti-SARS-CoV-2 S-RBD | Device ID: 2725 | Method: | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun Covid-19 Ag CARD | Device ID: 2724 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SC2 Ag Rapid | Device ID: 2723 | Method: | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SC2 qPCR Rapid | Device ID: 2722 | Method: | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SC2 qPCR | Device ID: 2721 | Method: | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun Flu/SC2 qPCR | Device ID: 2720 | Method: | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun FluA/FluB/SC2 qPCR | Device ID: 2719 | Method: | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun Covid-19 Ab CARD | Device ID: 2718 | Method: | Target: | Format: | 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