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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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1689 records found
CE Marking Manufacturer Commercial Name Method Target Format Navigate
CE Marking: No Manufacturer: SYN LAB Commercial: Test detection Coronavirus (COVID-19) Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Swedicine AB Commercial: Covid-19 Antigen Rapid Test Cassette Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Suzhou Kangheshun Medical Technology Commercial: SARS-CoV-2 IgG/IgM Rapid Test Cassette Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Suzhou Hybiome Biomedical Engineering Co., Ltd. Commercial: SARS-CoV-2 IgM (Chemiluminescent Immunoassay) Method: CLIA Target: Antibody, IgM Format: Automated, Lab-based Go to details
CE Marking: Yes Manufacturer: Suzhou Hybiome Biomedical Engineering Co., Ltd. Commercial: SARS-CoV-2 IgG (Chemiluminescent Immunoassay) Method: CLIA Target: Antibody, IgG Format: Automated, Lab-based Go to details
CE Marking: No Manufacturer: Suzhou BTA Biotech Co. Ltd Commercial: Real time RT-PCR Kit for the detection of SARS-CoV-2 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Surge Medical Inc. Commercial: COVID-19/Influenza A+ B Antigen Test Kit 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) Method: Immunoassay Target: Antibody, IgG, IgM Format: Go to details
CE Marking: Yes Manufacturer: Surge Medical Inc. Commercial: COVID-19 Antigen Test Kit Method: Immunoassay Target: Format: Go to details
CE Marking: Yes Manufacturer: SureScreen Diagnostics Commercial: SureScreen COVID19 IgM/IgG Rapid Test Cassette Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SureScreen Diagnostics Commercial: SureScreen COVID-19 Antigen Rapid Test Cassette Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SureScreen Diagnostics Commercial: Rapid Immunoassay Test Cassette Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Sure Bio-Tech (USA) Co., Ltd Commercial: SARS-CoV-2 IgM/IgG Ab Rapid Test Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Sure Bio-Tech (USA) Co., Ltd Commercial: SARS-CoV-2 IgM Ab Rapid Test Method: Immunoassay Target: Antibody, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Sure Bio-Tech (USA) Co., Ltd Commercial: SARS-CoV-2 IgG Ab Rapid Test Method: Immunoassay Target: Antibody, IgG Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Sure Bio-Tech (USA) Co., Ltd Commercial: Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Sure Bio-Tech (USA) Co., Ltd Commercial: 2019-nCoV Antigen Rapid Test (Colloidal Gold) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Sugentech, Inc Commercial: SGTi-flex COVID-19 IgM/IgG (RDT) Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Sugentech, Inc Commercial: SGTi-flex COVID-19 Ag Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Sugentech, Inc Commercial: SGT anti-SARS-CoV-2 total Ab ELISA Method: ELISA Target: Antibody Format: Automated, Manual Go to details
CE Marking: No Manufacturer: STILLA Commercial: COVID-19 Multiplex Crystal Digital PCR detection kit Method: Digital-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Star Array Ptd. Ltd Commercial: 8-minute RT-qPCR direct PCR testing system for SARS-CoV-2 detection Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Stanford Clinical Virology Laboratory Commercial: SARS-CoV-2 RT-PCR test Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: STAB VIDA Commercial: Dr Vida pocket for COVID-19 Method: LAMP Target: Format: Automated, Near POC / POC Go to details
CE Marking: No Manufacturer: St. Petersburg Research Institute of Vaccines and Sera (FSUE SPbSRIVS FMBA) Commercial: SARS-CoV-2 Tru-EIA Method: Immunoassay Target: Antibody Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Spring Healthcare Services AG Commercial: SARS-Cov-2 Antigen Rapid Test Cassette (swab) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Spring Healthcare Services AG Commercial: SARS-Cov-2 Antigen Rapid Test Cassette (Saliva) Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Spring Healthcare Services AG Commercial: COVID-19 IgG/IgM Rapid Test (colloidal gold-based) Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Spindiag GmbH Commercial: Rhonda Corona test Method: Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Spectrum for Diagnostic Industries Commercial: (SDI) SARS-CoV-2 Qualitative Real Time PCR Kit Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Specialty Diagnostic (SDI) Laboratories Commercial: SDI SARS-CoV-2 Assay Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Spark Diagnostics LLC Commercial: CoV-Check DIRECT Covid-19 Antigen Test Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Spark Diagnostics LLC Commercial: CoV-Check - COVID-19 IgG/IgM Test Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Sophonix Co., Ltd Commercial: SARS-CoV-2 IgG antibody test kit SARS-CoV-2 IgM antibody test (automated) Method: Immunoassay Target: Antibody Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Sona Nanotech Commercial: Sona Nanotech COVID-19 Lateral Flow Assay Lateral flow screening test for S1 domain of SARS-CoV-2 S1 protein Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Solis Biodyne Commercial: SOLIScript 1-step CoV Kit Method: RT-PCR Target: Nucleic acid Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Solgent Co., Ltd Commercial: DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: SNP Biotechnology R&D Ltd Co. Commercial: COVID-19 Real Time PCR Kit Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Snibe Co., Ltd Commercial: Molecision SARS-CoV-2 RT-PCR Assay Method: RT-PCR Target: Nucleic acid Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Snibe Co., Ltd Commercial: Molecision SARS-CoV-2 & Flu A/B RT-PCR Assay Method: RT-PCR Target: Nucleic acid Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Snibe Co., Ltd Commercial: MAGLUMI SARS-CoV-2 S-RBD IgG (CLIA) Method: CLIA Target: Antibody, IgG Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Snibe Co., Ltd Commercial: MAGLUMI SARS-CoV-2 Neutralizing Antibody (CLIA) Method: CLIA Target: Antibody Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Snibe Co., Ltd Commercial: MAGLUMI 2019-nCoV IgM (CLIA) Method: Immunoassay Target: Antibody, IgM Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Snibe Co., Ltd Commercial: MAGLUMI 2019-nCoV IgG (CLIA) Method: Immunoassay Target: Antibody, IgG Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Sinocare Commercial: SARS-CoV-2 Antibody Test strip (colloidal Gold Method) Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Sino Biological Commercial: SARS-CoV-2 (2019-nCoV) Spike RBD ELISA Kit Method: ELISA Target: Antigen Format: Automated, Manual Go to details
CE Marking: No Manufacturer: Sino Biological Commercial: SARS-CoV-2 (2019-nCoV) Spike Detection ELISA Kit Method: ELISA Target: Antigen Format: Automated, Manual Go to details
CE Marking: No Manufacturer: Sino Biological Commercial: SARS-CoV-2 (2019-nCoV) Nucleocapsid Detection ELISA Kit Method: ELISA Target: Antigen Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: SINGUWAY BIOTECH Inc Commercial: SINGUWAY COVID-19 Ag Test Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SINGUWAY BIOTECH Inc Commercial: Nucleic Acid Detection Kit For COVID-19 (PCR Fluorescence Probe) Method: RT-PCR Target: Nucleic acid Format: Automated, Manual 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