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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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373 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: Getein Biotech, Inc. Commercial: One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) Device ID: 2183 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Bionote, Inc Commercial: NowCheck COVID-19 Ag Test Device ID: 1242 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Apollo Biomedical LLC Commercial: Novel SARS-CoV-2 Coronavirus Spike Glycoprotein Detection Kit (S Protein-ACE2 receptor) Device ID: 1289 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Deangel Biological Engineering Co., Ltd Commercial: Novel Coronavirus S Glycoprotein Detection Kit Device ID: 1259 Method: Immunoassay 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 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 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: Hangzhou Realy Tech Co., Ltd Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva) Device ID: 1796 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co., Ltd Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) Device ID: 1220 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co., Ltd Commercial: Novel Coronavirus (SARS-Cov-2) Antigen rapid test Device ID: 1743 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Avioq Bio-Tech Co., Ltd Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit(Colloidal Gold) Device ID: 1972 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Hangzhou Laihe Biotech Co., Ltd. Commercial: Novel Coronavirus (COVID-19) Antigen Testkit (Colloidal Gold Device ID: 2224 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: BN Santé Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) Device ID: 1828 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co., Ltd Commercial: Novel Coronavirus (2019-nCOV) Antigen Rapid Test Cassette (Quantum Dot-based Fluorescence Immunochromatography) Device ID: 1795 Method: Immunochromatography Target: Antigen Format: Near POC / POC 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
CE Marking: Yes Manufacturer: Chongqing Novegent Biotech Company Limited Commercial: Novegent COVID-19 Antigen Rapid Test Kit Device ID: 1189 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Atlas Link Technology Co., Ltd. Commercial: NOVA Test® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) Device ID: 2010 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: NG Biotech Commercial: Ninonasal-Autotest Device ID: 2281 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: NG Biotech Commercial: Ninonasal Device ID: 1880 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: NG Biotech Commercial: NG-Test SARS-CoV-2 Ag Device ID: 1646 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Nal von minden GmbH Commercial: NADAL COVID-19 Ag Test Device ID: 1162 Method: Chromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Safecare Biotech (Hangzhou) Co. Ltd Commercial: Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19) Device ID: 1490 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: möLab Commercial: mö-screen Corona Antigen Test Device ID: 1190 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: MEXACARE GmbH Commercial: MEXACARE COVID-19 Antigen Rapid Test Device ID: 1775 Method: Chromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: MEDsan GmbH Commercial: MEDsan SARS-CoV-2 Antigen Rapid Test Device ID: 1180 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Wuhan NanoDiagnosis for Health Biotechnology Co., Ltd Commercial: Mednano Device ID: 1749 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BBB INC; Obelis S.A.(BE) Commercial: MARK-B COVID-19 Ag S Device ID: 1234 Method: Immunoassay Target: Antigen Format: Other Go to details
CE Marking: Yes Manufacturer: ArcDia International Ltd Commercial: mariPOC SARS-CoV-2 Device ID: 768 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Laihe Biotech Co., Ltd Commercial: LYHER Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) Device ID: 1215 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: LumiraDX Commercial: LumiraDx SARS-CoV-2 Ag Test Device ID: 1268 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Laipac Technology Inc. Commercial: LooK SPOT Device ID: 1667 Method: Immunoassay Target: Antigen Format: Automated Go to details
CE Marking: Yes Manufacturer: Zhuhai Livzon Diagnostics Inc Commercial: Livzon Test for SARS-CoV-2 Antigen (Fluorescence Immunochromatographic Assay) Device ID: 1442 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Zhuhai Livzon Diagnostics Inc Commercial: Livzon Rapid Test for SARS-CoV-2 Antigen (Lateral Flow) Device ID: 1441 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BMT Diagnostics Commercial: Lab-On-Time COVID-19 Antigen Rapid Test Device (Integrated Throat Swab) Device ID: 1605 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Zhejiang Quark Biotechnology Co., Ltd Commercial: Kwork Covid-19 Ag Rapid Test Device(Saliva/Sputum/Feces) Device ID: 1322 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 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 (Colloidal Gold) Device ID: 1284 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou GENESIS Biodetection and Biocontrol CO.,LTD Commercial: KaiBiLi COVID-19 Antigen Device ID: 2085 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC 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: Alfa Scientific Designs Inc Commercial: Instant-view® PLUS COVID-19 Antigen Test Device ID: 1678 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Vitrosens Biotechnology Co., Ltd Commercial: Instant SARS-CoV-2 Rapid Ag Test Device ID: 1444 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Nantong Diagnos Biotechnology Co., Ltd Commercial: Influenza A+B Antigen Test Kit (Colloidal Gold) Device ID: 1301 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Immuno Biotech Co.,Ltd Commercial: Immunobio SARS-CoV-2 Antigen ANTERIOR NASAL Rapid Test Kit (minimal invasive) Device ID: 1844 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Metas Biomedical Inc. Commercial: ImmTek COVID-19 Antigen Rapid Test Device ID: 1928 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd Commercial: iFlash-2019-nCoV Antigen Device ID: 1169 Method: Immunoassay Target: Antigen Format: Automated Go to details
CE Marking: Yes Manufacturer: Innovative Diagnostics Commercial: iD Rapid® COVID-19 Antigen Device ID: 1728 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Boditech Med Inc Commercial: ichroma™ COVID-19 Ag Device ID: 1990 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Humasis Commercial: Humasis COVID-19/Flu Ag Combo Test Device ID: 1262 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Humasis Commercial: Humasis COVID-19 Ag Test Device ID: 1263 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