| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: 3D Biomedicine Science & Technology Co., Limited | Commercial: 96A Viral RNA Auto Extraction & Purification Kit | Device ID: 2254 | Method: | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Avacta Life Sciences Ltd | Commercial: AffiDX SARS-CoV-2 Antigen Lateral Flow Test | Device ID: 2426 | Method: | Target: Antigen | Format: | 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: Neo-nostics (Suzhou) Bioengineering Co., Ltd. | Commercial: COVID 19 Antigen Test Kit (Colloidal Gold Method) | Device ID: 2608 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Beijing O&D Biotech Co., Ltd. | Commercial: COVID-19 Antigen Rapid Test | Device ID: 2494 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Beier Bioengineering Co.,Ltd | Commercial: Covid-19 Antigen Rapid Test Kit | Device ID: 2653 | Method: | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Surge Medical Inc. | Commercial: COVID-19 Antigen Test Kit | Device ID: 1942 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Surge Medical Inc. | Commercial: COVID-19 IgG/IgM Antibody Assay Kit(Colloidal Gold Method) | Device ID: 1932 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Vircell, s.l. | Commercial: COVID-19 SPIKE QUANTITATIVE VIRCLIA® IgG MONOTEST | Device ID: 2081 | Method: Immunoassay | Target: Antibody, IgG | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Singclean Medical Products Co., Ltd. | Commercial: COVID-19 Test Kit (Colloidal Gold Method) (Nasal Swab) | Device ID: 2609 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Surge Medical Inc. | Commercial: COVID-19/Influenza A+ B Antigen Test Kit | Device ID: 1943 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Diasia Biomedical Technology Co., Ltd. | Commercial: Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay) | Device ID: 2096 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: No | Manufacturer: Diasia Biomedical Technology Co., Ltd. | Commercial: Diagnostic Kit for SARS-CoV-2 Nucleic Acid(RT-PCR) | Device ID: 2140 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Diasia Biomedical Technology Co., Ltd. | Commercial: Diasia | Device ID: 1977 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Vircell, s.l. | Commercial: DIRECT SARS-COV-2 REALTIME PCR KIT | Device ID: 2082 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc., | Commercial: GenSure COVID-19 Neutralizing Antibody Test (Latex) | Device ID: 2112 | Method: Immunoassay | Target: Antibody | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Bionaire Biotech Co., Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test (Colloidal Gold) | Device ID: 2577 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Realy Tech | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 2298 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd. | Commercial: Novel Coronavirus 2019-nCOV Nucleic Acid Typing Test Kit (Real-Time PCR) | Device ID: 1971 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc. | Commercial: PCL COVID19 Ag Gold | Device ID: 2243 | Method: Immunochromatography | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Polonord Adeste Srl | Commercial: POLOFLUOR 2 | Device ID: 2583 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: No | Manufacturer: Healgen Scientific | Commercial: Rapid COVID-19 AntigenTest | Device ID: 1612 | Method: CLIA | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: 3D Biomedicine Science & Technology Co., Limited | Commercial: Sample Transport Medium | Device ID: 2255 | Method: | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Diasia Biomedical Technology Co., Ltd. | Commercial: SARA-CoV-2 Antigen Rapid Test Kit | Device ID: 1986 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 & Influenza A/B Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) | Device ID: 2221 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: BN Santé | Commercial: SARS-CoV-2 Antigen Rapid test | Device ID: 1964 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: POLY-DETECH RAPIDTECH | Commercial: SARS-CoV-2 antigen rapid test | Device ID: 2483 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: ACON Biotech (Hangzhou) Co., Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Self-Testing) | Device ID: 2451 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories, Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test (Self-Testing) | Device ID: 2452 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Diasia Biomedical Technology Co., Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 2203 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 1888 | Method: Immunoassay | Target: Antigen | Format: | 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: Shenzhen Microprofit Biotech Co., Ltd | Commercial: SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay) | Device ID: 1228 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Vircell, s.l. | Commercial: SARS-COV-2 VARIANTS REALTIME PCR KIT | Device ID: 2084 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Vector-Best | Commercial: SARS-CoV-2-IgM-EIA-BEST | Device ID: 1464 | Method: Immunoassay | Target: Antibody, IgM | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Vircell, s.l. | Commercial: SARS-CoV-2/FLU/RSV REALTIME PCR KIT | Device ID: 2083 | Method: RT-PCR | Target: Nucleic acid | Format: | 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: | Go to details |
| CE Marking: Yes | Manufacturer: BOME TRIVITRON | Commercial: TRIMARIS SARS-CoV-2 RT-qPCR Kit | Device ID: 2259 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd, China | Commercial: VivaDiag SARS-CoV-2 Ag Rapid Test | Device ID: 2471 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd | Commercial: VivaDiag SARS-CoV-2 Ag Saliva Rapid Test | Device ID: 1980 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Addbio Meditek Co. | Commercial: AddMedi SARS-CoV-2 RT-qPCR Kit | Device ID: 2020 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: AFIAS COVID-19 Ab, IgM/IgG | Device ID: 836 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: AFIAS COVID-19, Viral Antigen | Device ID: 105 | Method: Immunoassay | Target: Antigen | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Alphadia | Commercial: Alphadia | Device ID: 1803 | Method: Immunoassay | Target: IgG | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: 3D Biomedicine Science & Technology Co., Limited | Commercial: ANDiS Viral RNA Auto Extraction & Purification Kit | Device ID: 2253 | Method: | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS., LTD. | Commercial: Anti-SARS-CoV-2 RBD CLIA Microparticles | Device ID: 2429 | Method: CLIA | Target: Antibody | Format: Automated | 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: Mylab Discovery Solutions Pvt. Ltd. | Commercial: COMPACT X/COMPACT XL- Nucleic Acid Sample Extraction and Preparation Instrument | Device ID: 2344 | Method: RT-PCR | Target: | Format: Automated | 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: NanoEntek | Commercial: FREND COVID-19 Ag | Device ID: 1420 | Method: Immunoassay | Target: Antigen | Format: Automated | 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