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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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2291 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: Beijing Bohui Innovative Biotechnology Co., Ltd. Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Quantum Dots Fluorescence Immunoassay) Device ID: 2047 Method: Immunochromatography Target: Antibody Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Beijing Bohui Innovative Biotechnology Co., Ltd. Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody Detection Kit (Competitive ELISA) Device ID: 2045 Method: ELISA Target: Antibody Format: Automated, Manual Go to details
CE Marking: No Manufacturer: Beijing Decombio Biotechnology Commercial: Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette Device ID: 666 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd Commercial: 2019-nCoV Antigen Rapid Test Kit (colloidal gold assay) Device ID: 1283 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd Commercial: 2019-nCoV IgG Antibody Determination Kit Device ID: 63 Method: Immunoassay Target: Antibody, IgG Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd Commercial: 2019-nCoV IgG/IgM Antibody Rapid Test Kit Device ID: 960 Method: Immunoassay Target: Antibody, IgG, IgM Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd Commercial: 2019-nCoV IgM Antibody Determination Kit Device ID: 62 Method: Immunoassay Target: Antibody, IgM Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Beijing Genskey Medical Technology Co., Ltd Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (RT-qPCR with Taqman-Probe) Device ID: 64 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Beijing Hotgen Biotech Co., Ltd Commercial: Coronavirus disease (COVID-19) Antibody Test (Colloidal Gold) Device ID: 519 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Hotgen Biotech Co., Ltd Commercial: Coronavirus disease (COVID-19) Antibody Test (Up-converting Phosphor Technology) Device ID: 521 Method: Immunoassay 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: 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: No Manufacturer: Beijing Hotgen Biotech Co., Ltd. Commercial: Coronavirus (2019-nCoV) -Antigentest Device ID: 2292 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Beijing Hotgen Biotech Co., Ltd. Commercial: Coronavirus (2019-nCoV) -Antigentest-Speichel Device ID: 2293 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: 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 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 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: 1997 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Beijing O&D Biotech 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: 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 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 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: 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: Immunoassay Target: Antigen Format: Near POC / POC 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

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