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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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1176 records found
CE Marking Manufacturer Commercial Name Method Target Format Navigate
CE Marking: Yes Manufacturer: Lifotronic Technology Co, Ltd Commercial: Antigen Rapid Test Ag SARS-CoV-2 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Liming Bio Commercial: Rapid Test Antigen SARS- CoV-2 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Liming Bio-Products Co., Ltd Commercial: COVID-19 Antigen Rapid Test Device 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 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Liming Bio-Products Co., Ltd Commercial: SrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit 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 Method: Immunochromatography Target: Antigen Format: Near POC / POC 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) 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 Method: Immunoassay Target: Antibody Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Luminex Corp. Commercial: NxTAG CoV Extended Panel Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: LumiQuick Diagnostics Inc Commercial: QuickProfile 2019-nCoV IgG/IgM Combo Test Card Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: LumiQuick Diagnostics Inc Commercial: QuickProfile COVID-19 Antigen Test Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: LumiraDX Commercial: SARS-CoV-2 Antibody Test Method: Immunoassay Target: Antibody, IgA Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: LumiraDX Commercial: SARS-CoV-2 Antigen Test Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: LumiraDX UK Ltd Commercial: LumiraDx SARS-CoV-2 Ag Test Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Lungene Commercial: COVID-19 Antigen Rapid Test Cassette Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Luxus Lebenswelt GMBH (Beijing NaGene Diagnosis Reagent Co., Ltd) Commercial: COVID-19 mouth and throat Swab Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: M monitor Inc Commercial: Isopollo COVID-19 detection Kit (real-time) Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Mabsky Bio-Tech Co., Ltd Commercial: COVID-19 virus (2019-nCoV) Dual-Detection Kit Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Mabsky Bio-Tech Co., Ltd Commercial: COVID-19 virus (2019-nCOV) Triple-Detection Kit (Real-Time PCR Method) Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Mabsky Bio-Tech Co., Ltd Commercial: Influenza A virus, Influenza B virus & COVID-19 virus (2019-nCoV) Triple-Detection Kit Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Maccura Biotechnology Co., Ltd Commercial: Maccura SARS-CoV-2 IgG Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Maccura Biotechnology Co., Ltd Commercial: Maccura SARS-CoV-2 IgM Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Maccura Biotechnology Co., Ltd Commercial: SARS-CoV-2 Fluorescent PCR Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Maccura Biotechnology Co., Ltd Commercial: SARS-CoV-2 IgG (CLIA) Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Maccura Biotechnology Co., Ltd Commercial: SARS-CoV-2 IgM (CLIA) Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Maccura Biotechnology Co., Ltd. Commercial: SARS-CoV-2 Fluorescent PCR Kit Method: RT-PCR Target: Format: Automated Go to details
CE Marking: Yes Manufacturer: Maccura Biotechnology Co., Ltd. Commercial: Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) Antigen Assay Kit by Colloidal Gold Method Method: Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Maccura Biotechnology Co., Ltd. Commercial: Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method Method: Immunochromatography Target: Antibody, IgG, IgM Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Medakit Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Medakit Ltd Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) Method: Immunoassay Target: IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. Commercial: Flu A/Flu B/SARS-CoV-2 Antigen (GICA) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. Commercial: SARS-CoV-2 Antigen (GICA) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. Commercial: SARS-CoV-2 IgG (CLIA) Method: CLIA Target: Antibody, IgG Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. Commercial: SARS-CoV-2 IgG/IgM (GICA) Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. Commercial: SARS-CoV-2 IgM (CLIA) Method: CLIA Target: Antibody, IgM Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. Commercial: SARS-CoV-2 NAbs (CLIA) Method: CLIA Target: Antibody Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Mediagnost Commercial: Anti-SARS-CoV-2 IgG ELISA Method: ELISA Target: Antibody, IgG Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Medical Innovation Ventures Sdn Bhd. Commercial: GenoAmp Real-Time RT-PCR SARS-CoV-2 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: MedicalSystem Biotechnology Co., Ltd Commercial: COVID-19 IgM/IgG Rapid Test Cassette Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Medigen Vaccine Biologics Corp. Commercial: MVC SARS-CoV-2 Real-Time PCR Diagnostic Kit Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Medikit Commercial: MediKit Covid-19 Antibody Test (IgM/IgG Lateral flow Immunoassay) Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Medisys International SA Gmate Covid-19 Commercial: Gmate Covid-19 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: MEDsan GmbH Commercial: MEDsan COVID-19 IgM/IgG Rapid Test Hybrid Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: MEDsan GmbH Commercial: MEDsan SARS-CoV-2 Antigen Rapid Test Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Megna Health Inc Commercial: Rapid COVID-19 Antigen Qualitative Test Kit Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Megna Health Inc Commercial: Rapid COVID-19 IgM/IgG Combo Test Kit (Antibody) Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Meril Diagnostics Pvt Ltd Commercial: Meril COVID-19 One-step RT-PCR Kit Method: RT-PCR Target: Nucleic acid Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: MERIL DIAGNOSTICS PVT LTD. Commercial: COVID-19 Antigen Detection Test Method: Immunochromatography Target: Antigen Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Meslo Commercial: COVID-19 qPCR kit Method: RT-PCR Target: Nucleic acid Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Metas Biomedical Inc. Commercial: ImmTek COVID-19 Antigen Rapid Test Method: Immunochromatography 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