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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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2883 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: Beijing Hotgen Biotech Co. Ltd. Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold) Device ID: 2808 Method: Immunochromatography Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Hotgen Biotech Co. Ltd. Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) Device ID: 2841 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Hotgen Biotech Co. Ltd. Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) Device ID: 1870 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Hotgen Biotech Co. Ltd. Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) - Saliva Device ID: 1798 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Hotgen Biotech Co. Ltd. Commercial: Novel Coronavirus(SARS-CoV-2) Neutralizing AntibodiesTest (Up-converting Phosphor Immunochromatographic Technology) Device ID: 2809 Method: Immunochromatography Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Hotgen Biotech Co. Ltd. Commercial: SARS-CoV-2 (S-RBD & NP) Antibody Test (Colloidal Gold) Device ID: 2811 Method: Immunochromatography Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Hotgen Biotech Co. Ltd. Commercial: SARS-CoV-2 and Flu A/B Antigen Combo Rapid Test (Colloidal Gold) Device ID: 2810 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Beijing Infervision Technology Co. Ltd. Commercial: InferRead CT Pneumonia Device ID: 65 Method: Other Target: Other Format: Other Go to details
CE Marking: Yes Manufacturer: Beijing Jinwofu Bioengineering Technology Co. Ltd. Commercial: Jinwofu® Novel Coronavirus (SARS-CoV-2) Antigen-Rapid-Test Device ID: 1725 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Jinwofu Bioengineering Technology Co. Ltd. Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit Device ID: 2072 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. Commercial: COVID19 Antigen Rapid Test Kit Device ID: 1778 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. Commercial: Genonto RapidTest10 COVID-19 IgG/IgM Antibody Rapid Test Kit Device ID: 707 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold) Device ID: 1284 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. Commercial: Kewei COVID-19 Antigen Rapid Test Kit (FIA) Device ID: 70 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence) Device ID: 1285 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. Commercial: Kewei COVID-19 IgG antibody ELISA Test Kit Device ID: 69 Method: ELISA Target: Antibody, IgG Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. Commercial: Kewei COVID-19 IgG/IgM antibody Rapid Test Kit (Colloidal Gold) Device ID: 71 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. Commercial: Kewei COVID-19 IgM antibody ELISA Test Kit Device ID: 67 Method: ELISA Target: Antibody, IgM Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. Commercial: Kewei COVID-19 RT-PCR Test Kit Device ID: 832 Method: RT-PCR Target: Nucleic acid Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. Commercial: Kewei COVID-19 total antibody ELISA Test Kit Device ID: 1111 Method: ELISA Target: Antibody Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. Commercial: Kewei COVID-19 total antibody rapid test Device ID: 1112 Method: Immunoassay Target: Antibody Format: Automated, Manual Go to details
CE Marking: No Manufacturer: Beijing Kinhawk Pharmaceutical Co. Ltd. Commercial: 2019-nCoV ORF1ab/N Gene Detection Kit (Fluorescence PCR Method) Device ID: 73 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Beijing Lepu Medical Technology Co. Ltd. Commercial: 2019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) Device ID: 1790 Method: Immunochromatography Target: Antigen Format: Other Go to details
CE Marking: Yes Manufacturer: Beijing Lepu Medical Technology Co. Ltd. Commercial: 2019-nCoV antigen, Influenza A virus antigen, Influenza B virus antigen detection kit (colloidal gold immunochromatography) Device ID: 3078 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Beijing Lepu Medical Technology Co. Ltd. Commercial: Nucleic Acid Extraction or Purification Kit Device ID: 1857 Method: Other Target: Nucleic acid Format: Automated Go to details
CE Marking: Yes Manufacturer: Beijing Lepu Medical Technology Co. Ltd. Commercial: Nucleic Acid Extraction or Purification Kit (Manual method) Device ID: 1858 Method: N.A. Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Beijing Lepu Medical Technology Co. Ltd. Commercial: SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) Device ID: 523 Method: Immunochromatography Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Lepu Medical Technology Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) Device ID: 1331 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Lepu Medical Technology Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test Kits for Self-testing (Colloidal Gold Immunochromatography) Device ID: 2881 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Beijing Lepu Medical Technology Co. Ltd. Commercial: SARS-CoV-2 Nucleic Acid Test Kit (PCR-Fluorescence Probe Method) Device ID: 1859 Method: Other Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Beijing NaGene Diagnosis Reagent Co. Ltd. Commercial: Multiple Real-Time PCR kit for Detection of 2019-nCoV Device ID: 75 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Beijing North Institute of Biotechnology Co. Ltd. Commercial: COVID-19 Antigen Rapid Test Device ID: 3009 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing North Institute of Biotechnology Co. Ltd. Commercial: COVID-19 TEST RAPIDO ANTIGENE RICOV4 Device ID: 2733 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Beijing O&D Biotech Co. Ltd. Commercial: Coronavirus disease (COVID-19) Total Antibody Rapid Test (Colloidal Gold) Device ID: 667 Method: Immunoassay Target: Antibody Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Beijing O&D Biotech Co. Ltd. Commercial: COVID-19 Antigen Rapid Test Device ID: 2494 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Beijing Savant Biotechnology Co. Ltd. Commercial: Coronavirus (SARS-Cov-2) N protein Detection Kit (Fluorescence immunochromatography) Device ID: 76 Method: Immunochromatography Target: Antigen Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Beijing Savant Biotechnology Co. Ltd. Commercial: SARS-Cov-2 Antigen Fluorescence Rapid Detection Kit Device ID: 1235 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Beijing Shengkun Kangru Medical Equipment Co. Ltd. Commercial: 2019-nCoV Detection kit (quantum dot immunofluorescence method) Device ID: 78 Method: Other Target: Nucleic acid Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Beijing Strong Biotechnologies Inc. Commercial: SARS-CoV-2 Antigen Test Device ID: 3722 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Tigsun Diagnostics Co. Ltd. Commercial: Tigsun COVID-19 Antigen Rapid Test Device ID: 1292 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Tigsun Diagnostics Co. Ltd. Commercial: Tigsun COVID-19 Antigen Saliva Rapid Test Device ID: 1290 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Tigsun Diagnostics Co. Ltd. Commercial: Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method) Device ID: 77 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Unidiag Technology Inc. Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit (Colloidal Gold) Device ID: 3033 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. Commercial: SARS-CoV-2 Total Ab ELISA Device ID: 833 Method: ELISA Target: Antibody Format: Automated, Manual Go to details
CE Marking: No Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. Commercial: Wantai SARS-CoV-2 Ab Rapid Test Device ID: 82 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. Commercial: WANTAI SARS-CoV-2 Ag Rapid Test (Colloidal Gold) Device ID: 1485 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. Commercial: WANTAI SARS-CoV-2 Ag Rapid Test (FIA) Device ID: 1484 Method: Other Target: Antigen Format: Lab-based, Manual, Near POC / POC, Semi-automated Go to details
CE Marking: Yes Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. Commercial: Wantai SARS-CoV-2 IgM ELISA Device ID: 834 Method: ELISA Target: Antibody, IgM Format: Automated, Manual Go to details
CE Marking: No Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. Commercial: Wantai SARS-CoV-2 RT-PCR Kit Device ID: 81 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Beijing WSWY Technology Co. Ltd. Commercial: Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Quantum Dot-Based Fluorescence Immunochromatography) Device ID: 1362 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