| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Beijing Beier Bioengineering Co. Ltd. | Commercial: Covid-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 2667 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins GeneScan Technologies GmbH | Commercial: GSD NovaPrime IVD RNA Extraction AE2 | Device ID: 2666 | Method: Other | Target: | Format: Automated, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins GeneScan Technologies GmbH | Commercial: IFU NovaPrime IVD RNA Extraction AE1 RTU | Device ID: 2665 | Method: Other | Target: | Format: Automated, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins GeneScan Technologies GmbH | Commercial: NovaPrime IVD RNA Extraction AE1 | Device ID: 2664 | Method: Other | Target: | Format: Automated, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Biocartis | Commercial: IdyllaTM SARS-COV-2/FLU/RSV Panel | Device ID: 2663 | Method: RT-PCR | Target: | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: Biocartis | Commercial: IdyllaTM SARS-COV-2 Test | Device ID: 2662 | Method: RT-PCR | Target: Nucleic acid | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: WIZCHEM Co. Ltd. | Commercial: COVICHEK COVID-19 Ag KIT | Device ID: 2661 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Shenzhen Kisshealth Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (GICA)-Nasal(Anterioar) Swab | Device ID: 2660 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Shenzhen Kisshealth Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (GICA)-Saliva | Device ID: 2659 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co. Ltd. | Commercial: SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasal (self-test) | Device ID: 2658 | Method: Immunochromatography | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC SRL | Commercial: Kit Multiplex (q)RT-PCR(X) for detection of SARS-CoV-2 | Device ID: 2657 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genes Laboratories | Commercial: GCdia™ COVID-19 Fast Detection Kit | Device ID: 2656 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: cue health Inc. | Commercial: cue health | Device ID: 2655 | Method: Digital-PCR | Target: | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: LUCA AICELL Inc. | Commercial: LUCA NK COVID-19 Ag LLB | Device ID: 2654 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: WIZCHEM Co. Ltd. | Commercial: COVICHEK COVID-19 Ag Saliva HT | Device ID: 2652 | Method: Immunochromatography | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Deep Blue Medical Technology Co. Ltd. | Commercial: COVID-19 (SARS-CoV-2) Antigen Test Midstream — Saliva | Device ID: 2651 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vision Biotechnology | Commercial: Vision Biyoteknoloji Araştırma Geliştirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited Şirketi | Device ID: 2650 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Taizhou ZECEN Biotech Co. Ltd. | Commercial: SARS-CoV-2 IgG/IGM Rapid t | Device ID: 2649 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Coris BioConcept | Commercial: Covid-19 Ag K-SeT | Device ID: 2648 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Dräger Safety AG & Co. KGaA | Commercial: Dräger COVID-19 Home Test | Device ID: 2647 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: QuantuMDx Group Ltd. | Commercial: Q-POC | Device ID: 2646 | Method: RT-PCR | Target: | Format: Automated, Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: LumiraDx UK Ltd. | Commercial: LumiraDx SARS-CoV-2 RNA STAR Complete | Device ID: 2645 | Method: RT-PCR | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Dixion Vertrieb medizinischer Geräte GmbH and Shenzhen Dymind Biotechnology Co. Ltd. | Commercial: Dixion Sars-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2644 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genobio Pharmaceutical Co. Ltd. | Commercial: Virusee® SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) | Device ID: 2642 | Method: Immunoassay | 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 Nasal) | Device ID: 2641 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mologic Ltd. | Commercial: COVIOS Ag COVID-19 Antigen Rapid Diagnostic Test | Device ID: 2640 | Method: | Target: Antigen | 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: Delta Chemie Biotechnology SAS | Commercial: OneCheck Covid-19 IgG Spike RBD | Device ID: 2638 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Delta Chemie Biotechnology SAS | Commercial: OneCheck Covid-19 Ag Saliva | Device ID: 2637 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: Humasis Co. Ltd. | Commercial: Celltrion DiaTrust ™– Covid-19 Ag Rapid Test | Device ID: 2635 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Laihe Biotech Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) - (saliva, sputum) | Device ID: 2634 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Aripa Biotec GmbH | Commercial: Anti-SARS-CoV-2-Multi-Antikörper IgG/Nab-Test (IgG-Antikörper/neutralisierende Antikörper) (LFIA) | Device ID: 2633 | Method: Immunochromatography | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Cofoe Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit(Colloidal Gold Method) | Device ID: 2632 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SLSBio Co. Ltd. | Commercial: SSmarTest COVID19 Spike Protein Ab(IgM/IgG) Test | Device ID: 2631 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SLSBio Co. Ltd. | Commercial: SsmarTest COVID-19 Ag Detection Kit | Device ID: 2630 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Dian Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Test Cassette | Device ID: 2629 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hipro Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) - Saliva | Device ID: 2628 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Blue Cross Bio-Medical（Beijing） Co. Ltd. | Commercial: COVID-19 Antigen Test | Device ID: 2627 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: Mutation of SARS-CoV-2 nucleic acid Detection Kit（Real Time PCR） | Device ID: 2626 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: Novel Coronavirus(SARS-CoV-2) Nucleic Acid Detection Kit (Isothermal Amplification) | Device ID: 2625 | Method: | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: 2019-nCoV Nucleic acid Detection Kit (Real Time PCR) | Device ID: 2624 | 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 Test | Device ID: 2623 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: LoopDeeScience | Commercial: LoopDeetect COVID 19 IC | Device ID: 2622 | Method: LAMP | Target: | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Detection Kit(Fluorescence Immunoassay) | Device ID: 2621 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 2620 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: CapitalBio Technology | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Integrated Isothermal Amplification Chip Method) | Device ID: 2619 | Method: LAMP | Target: Nucleic acid | Format: Automated, Lab-based, 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: SPESERA SAĞLIK ÜRÜNLERİ İÇ VE DIŞ Ltd. ŞTİ. | Commercial: SPESERA Covid-19 AG/Influenza A&B Combo Rapid Test Cassette | Device ID: 2617 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SPESERA SAĞLIK ÜRÜNLERİ İÇ VE DIŞ Ltd. ŞTİ. | Commercial: SPESERA Covid-19 Antibody IgG-IgM Rapid Test Cassette | Device ID: 2616 | Method: Immunochromatography | 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