CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Laipac Technology Inc. | Commercial: LooK SPOT 2 | Device ID: 2368 | Method: Immunoassay | Target: Antigen | Format: Automated, Other | Go to details |
CE Marking: No | Manufacturer: Landcent Europe B.V. | Commercial: Real time RT-PCR Kit for the detection of SARS-CoV-2 | Device ID: 256 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Langfang Xinruikang Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Colloidal gold immunochromatographic assay) | Device ID: 3092 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Langfang Xinruikang Biotechnology Co. Ltd. | Commercial: COVID-19 Nucleic Acid Detection Kit (RT-LAMP) | Device ID: 3091 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Lansion Biotechnology Co. Ltd. | Commercial: (COVID-19) IgM/IgG Test Kit (Dry Fluorescence Immunoassay) | Device ID: 1649 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lansion Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Dry Color Latex Immunoassay) | Device ID: 2869 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lansion Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Dry Color Latex Immunoassay) for self-testing use | Device ID: 3123 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Lansion Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay) | Device ID: 1648 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lansion Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (DryColorLatex Immunoassay) | Device ID: 2818 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Leadgene Biomedical Inc. | Commercial: Leadgene SARS/SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 257 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Leadgene Biomedical Inc. | Commercial: Leadgene SARS/SARS-CoV-2 IgG/IgM Rapid Test Kit | Device ID: 258 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LiClear Biotech (Hangzhou) Co., Ltd | Commercial: SARS-COV-2 Nucleocapsid (N) Antigen Rapid Test Cassette | Device ID: 3973 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lifeassay Diagnostics Pty Ltd. | Commercial: LEPZI Qualitative COVID-19 Test | Device ID: 3151 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Lifeassay Diagnostics Pty Ltd. | Commercial: Test-it COVID-19 IgM/IgG Lateral Flow Assay | Device ID: 259 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lifecosm Biotech Limited | Commercial: COVID-19 Antigen Test Cassette | Device ID: 2866 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Liferiver | Commercial: Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCRT kit | Device ID: 260 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Lifotronic Technology Co. Ltd. | Commercial: Antigen Rapid Test Ag SARS-CoV-2 | Device ID: 1592 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Liming Bio-Products Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Device | Device ID: 263 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Liming Bio-Products Co. Ltd. | Commercial: COVID-19 IgG/IgM Combo Rapid Test Device | Device ID: 264 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Liming Bio-Products Co. Ltd. | Commercial: Rapid Test Antigen SARS- CoV-2 | Device ID: 1824 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Liming Bio-Products Co. Ltd. | Commercial: SrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit | Device ID: 262 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: LINEAR CHEMICALS S.L.U. | Commercial: Cromatest COVID-19 Antigen Cassette | Device ID: 1867 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Linkcare Health Services (Diagnos BT) | Commercial: Covid-19 Antigen Test Kit (Colloidal Gold) | Device ID: 1353 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Lionrun | Commercial: Diagnostic kit for antibody IgM/IgG of Novel Coronavirus COVID-19 | Device ID: 1633 | Method: Immunoassay | Target: Antibody | 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: Yes | Manufacturer: LOMINA AG | Commercial: COVID-19 Antigen Rapid Test Device; SARS-CoV-2 (N)protein Antigen rapid test (Fluorescence Immunochromatics assay) | Device ID: 678 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LOMINA AG | Commercial: SARS-CoV-2(COVID19)IgM/IgG Antibody Fast Detection Kit | Device ID: 265 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Lomina Sperbio a.s. | Commercial: Lomina SARS-CoV-2 Antigen LTX Selftest | Device ID: 3678 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lomina Superbio a.s. | Commercial: Lomina SARS-CoV-2 Antigen LTX Selftest | Device ID: 4070 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lomina Superbio a.s. | Commercial: Lomina SARS-CoV-2 Antigen LTX test | Device ID: 2560 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: Lomina Superbio a.s. | Commercial: LOMINA SARS-CoV-2 N-Protein Antigen Rapid Test | Device ID: 2158 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: Lomina Superbio a.s. | Commercial: Lomina SARS-CoV-2+ Influenza A/B Antigen LTX Test | Device ID: 4147 | 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: LT Biotech JSC | Commercial: COVID19AgLTFLOW | Device ID: 2094 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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: LUCA AICELL Inc. | Commercial: LUCA NK COVID-19 Ag Nasal LLB | Device ID: 2668 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LUCA AICELL Inc. | Commercial: LUCA NK COVID-19 Ag NP LLB | Device ID: 2670 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LUCA AICELL Inc. | Commercial: LUCA NK COVID-19 Ag Saliva LLB | Device ID: 2669 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Lucira Health | Commercial: Lucira COVID-19 All-In-One Test Kit | Device ID: 1374 | Method: LAMP | Target: Nucleic acid | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Lumex Instruments | Commercial: Microchip RT-PCR COVID-19 detection system | Device ID: 580 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Lumigenex (Suzhou) Co. Ltd. | Commercial: PocRoc®SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 2128 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Luminex Corp. | Commercial: ARIES SARS-CoV-2 Assay | Device ID: 481 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Luminex Corp. | Commercial: NxTAG CoV Extended Panel | Device ID: 266 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Luminex Molecular Diagnostics Inc. | Commercial: NxTAG® Respiratory Pathogen Panel + SARS-CoV-2 | Device ID: 2518 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
CE Marking: No | Manufacturer: Luminostics Inc. | Commercial: CLIP-COVID19 (smartphone-read out high sensivity antigen detection test) | Device ID: 267 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LumiQuick Diagnostics Inc. | Commercial: QuickProfile 2019-nCoV IgG/IgM Combo Test Card | Device ID: 268 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LumiQuick Diagnostics Inc. | Commercial: QuickProfile COVID-19 Antigen Test | Device ID: 1267 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LumiraDx UK Ltd. | Commercial: Dual-Target SARS-CoV-2 STAR Complete | Device ID: 3924 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: LumiraDx UK Ltd. | Commercial: LumiraDx SARS-CoV-2 Ag Test | Device ID: 1268 | Method: Immunoassay | 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