| 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: 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: CerTest Biotec | Commercial: CerTest SARS-CoV-2 | Device ID: 1173 | Method: | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CORETEST, INC. | Commercial: COVID-19 Ag Test | Device ID: 2967 | Method: | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: AEHEALTH LIMITED | Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 2676 | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Rapid Test Device | Device ID: 2287 | Method: | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SPAN BIOTECH Ltd. | Commercial: COVID-19(SARS-CoV-2) Antigen Test Kit (Nasal Swab) | Device ID: 2819 | Method: | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Synthgene Medical Technology Co. Ltd. | Commercial: COVID-19/Influenza A+B Antigen Combo Rapid Test Kit (Colloidal gold method) | Device ID: 3525 | Method: | 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: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun 2019-nCoV IgM/IgG rapid | Device ID: 2716 | Method: | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun 2019-nCoV qPCR | Device ID: 2713 | Method: | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun 2019-nCoV rapid | Device ID: 2715 | Method: | Target: | 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 Ab CARD | Device ID: 2718 | Method: | Target: | 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 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/2019-nCoV qPCR | Device ID: 2714 | 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 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 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 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 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 | Device ID: 2721 | Method: | Target: | 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: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: iFlash-SARS-CoV-2 IgG-S | Device ID: 2697 | Method: | Target: Antibody | Format: | Go to details |
| CE Marking: Yes | Manufacturer: InActiv Blue | Commercial: InActiv Blue Saliva Collection Kit | Device ID: 2680 | Method: | Target: | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: Maverick- Nucleic Acid Extraction Kit (Magnetic Bead Based) | Device ID: 2355 | Method: | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: MEDICE Arzneimittel Pütter GmbH & Co. KG | Commercial: Medicovid-AG SARS-CoV-2 Antigen Selbsttest-Nase | Device ID: 2318 | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Synthgene Medical Technology Co. Ltd. | Commercial: Nanjing Synthgene Medical Technology Co., Ltd. | Device ID: 3693 | Method: | Target: Antigen | 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: simin.chen@lifotronic.com | Commercial: Nucleic Acid Extraction Reagent | Device ID: 2614 | Method: | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co. Ltd. | Commercial: RAPID 2019-NCOV IGG/IGM COMBO TEST CARD | Device ID: 2286 | Method: | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Reszon Diagnostics International Sdn. Bhd. | Commercial: Reszon COVID-19 Rapid Antigen Test (Saliva) | Device ID: 3165 | Method: | Target: Antigen | Format: Manual | 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: Labnovation Technologies, Inc. | Commercial: SARS-CoV-2 Antigen & Influenza A/B Rapid Test Kit(Immunochromatography) | Device ID: 3928 | Method: | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: LLC EMG- Evotech Mirai Genomics | Commercial: SmartAmp SARS-CoV-2 RNA detection test kit | Device ID: 1951 | Method: | Target: Nucleic acid | Format: Manual, Other, Semi-automated | Go to details |
| CE Marking: No | Manufacturer: Solis Biodyne | Commercial: SOLIScript 1-step CoV Kit | Device ID: 886 | Method: | Target: | Format: | 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: HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd. | Commercial: The COVID-19 Antigen Rapid Test Device (Colloidal Gold) | Device ID: 3949 | Method: | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sense Biodetection Limited | Commercial: Veros™ COVID-19 | Device ID: 3067 | Method: | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: (COVID-19) IgM/IgG Antibody Rapid Test Kit | Device ID: 2703 | Method: Chromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biocomma limited | Commercial: biocomma®COVID-19 Antigen Test Kit | Device ID: 1687 | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CORMAY | Commercial: Cormay Rapid SARS-CoV-2 IgG/IgM Ab | Device ID: 1074 | Method: Chromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Bessie Biological Technology Co. ，Ltd. | Commercial: COVID- 19 Antigen Rapid Test Kit | Device ID: 4142 | Method: Chromatography | Target: Antigen, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: VEDALAB | Commercial: COVID-19-CHECK-1 test | Device ID: 1069 | Method: Chromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEXACARE GmbH | Commercial: MEXACARE COVID-19 Antigen Rapid Test | Device ID: 1775 | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidFor™ SARS-CoV-2 + FLU A/B + RSV+ADV Combo Test Kit | Device ID: 5816 | Method: Chromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidFor™ SARS-CoV-2 +FLUA/B + RSV + ADV + M. Pneumoniae Combo Test Kit | Device ID: 5834 | Method: Chromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Bioworld Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) | Device ID: 3088 | Method: Chromatography | Target: Antigen | Format: Lab-based | 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