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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Devices

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2888 records found
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