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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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163 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: 1drop Inc. Commercial: 1copy™ COVID-19 qPCR Triplex Kit Device ID: 2918 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: A PLUS DIAGNOSTICS LAB.SAN.TIC.A.S. Commercial: SMARTTEST SARS-COV-2 NASOPHARYNGEAL ANTIGEN RAPID TEST Device ID: 2985 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Abbott Rapid Diagnostics Commercial: Panbio Covid-19 Ag Rapid Test Device ID: 1232 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: abCyclerQd Real‐time PCR System Commercial: abCyclerQd Real‐time PCR System Device ID: 3132 Method: RT-PCR Target: Nucleic acid Format: Automated Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test Slim(Self-Testing) Device ID: 4052 Method: Immunochromatography Target: Antigen Format: Other Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex SARS-CoV-2 Antigen Saliva Rapid Test Lollipop (Self-Testing) Device ID: 4051 Method: Immunochromatography Target: Antigen Format: Other Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test (Self-Testing) Device ID: 2451 Method: Immunochromatography Target: Antigen Format: Go to details
CE Marking: Yes Manufacturer: ACON Laboratories Inc. Commercial: SARS-CoV-2 Antigen Rapid Test (Self-Testing) Device ID: 2452 Method: Immunochromatography Target: Antigen Format: Go to details
CE Marking: Yes Manufacturer: AMPER Inc. Commercial: Quadruple Fast Test Pen (Latex) For SARS-CoV-2 & influenza A/B antigens and COVID-19 Neutralizing antibody Device ID: 3579 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: AMPER Inc. Commercial: RSV-SC2-Flu Quadruplex Fast Test (Colloidal Gold) For RSV SARS-CoV-2 & Influenza A/B antigens Device ID: 5799 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Anhui Deep Blue Medical Technology Co. Ltd. Commercial: COVID-19 (SARS-CoV-2) Antigen Test Kit (self-testing) Device ID: 2750 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Aripa Biotec GmbH Commercial: COVID-19-N-Antigen Schnelltest SARS-CoV-2 Device ID: 2169 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Artron Laboratories Inc. Commercial: Artron COVID-19 Antigen Self Test Device ID: 5779 Method: Immunochromatography Target: Antigen Format: Other Go to details
CE Marking: Yes Manufacturer: Assure Tech (Hangzhou) Co. Ltd. Commercial: COVID-19 & Influenza A/B Antigen Nasal Test Kit Device ID: 3106 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech (Hangzhou) Co. Ltd. Commercial: COVID-19 Antigen Nasal Test Kit Device ID: 2933 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech (Hangzhou) Co. Ltd. Commercial: COVID-19 Antigen Saliva Test Kit Device ID: 2037 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech (Hangzhou) Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Tests for Self-Testing Device ID: 2932 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Atlas Link Technology Co. Ltd. Commercial: NOVA Test® SARS-CoV-2 Antigen Home Test Kit Device ID: 2956 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. Commercial: SARS-CoV-2 Ag Rapid Test (self-test) Device ID: 3082 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Beijing Applied Biological Technologies Co. Ltd. Commercial: 2019-nCoV Antigen Rapid Test Cassette Device ID: 3068 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Applied Biological Technologies Co. Ltd. Commercial: 2019-nCoV Antigen Rapid Test Cassette Anterior Nasal Swab Device ID: 3058 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Applied Biological Technologies Co. Ltd. Commercial: SARS-CoV-2 and Influenza Viruses A/B Rapid Test Cassette For self-testing use only Device ID: 3167 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Beijing Applied Biological Technologies Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test Cassette Device ID: 3044 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Applied Biological Technologies Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test Cassette Anterior Nasal Swab Device ID: 3059 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) Device ID: 3622 Method: Immunoassay Target: Antigen Format: Manual 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: Biobase Diagnostic Technology (Shandong) Co. Ltd. Commercial: BIOBASE COVID-19 Antigen Rapid Test (Self-testing) Device ID: 3112 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Biobase Diagnostic Technology (Shandong) Co. Ltd. Commercial: BIOBASE COVID-19 Antigen Rapid Test(Self-Test) Device ID: 3071 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: BioDetect (Xiamen) Biotechnology Co. Ltd. Commercial: RAPID SARS-COV-2 ANTIGEN TEST CARD (self test) Device ID: 2902 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BIOSYNEX S.A. Commercial: BIOSYNEX AUTOTEST ANTIGENIQUE COVID-19 Ag+ Device ID: 2964 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. Commercial: SARS-CoV-2 Antigen Test Kit Device ID: 3487 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Birmingham Biotech Ltd. Commercial: BHM COVID-19 Antigen Rapid Test Device ID: 3008 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: CAMP MEDICA DISTRIBUTION Commercial: See Now Coronavirus nCoV antigen test Device ID: 1999 Method: Immunochromatography Target: Antigen Format: Lab-based, Manual Go to details
CE Marking: Yes Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. Commercial: CHECK UP COVID19-INF A/B-RSV MULTI RAPID TEST KIT Device ID: 5817 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. Commercial: CheckUp COVID-INF A/B-RSV COMBO RAPID NASAL TEST KIT Device ID: 5820 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. Commercial: CHECKUP COVID-INF A/B-RSV-ADENO RAPID TEST KIT Device ID: 5832 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Changchun WanCheng Bio Electron Co. Ltd. Commercial: COVID-19 Antigen Rapid Test Device ID: 2934 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Changsha Sanji Bio-technology Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test (Lateral Flow Method) Device ID: 2990 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Changzhou Biowin Pharmaceutical Co. Ltd. Commercial: Biowin COVID-19 Antigen Nasal Test (Self-test) Device ID: 3148 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Chil Tıbbi Malzeme Sanayi ve Ticaret Limited Şirketi Commercial: CHIL COVID-19 Antigen Rapid Test Device ID: 3864 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: CITEST DIAGNOSTICS Inc. Commercial: COVID-19 and Flu A/B Multiplex Panel for Home Use (Nasal Swab) Device ID: 3142 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: CITEST DIAGNOSTICS Inc. Commercial: COVID-19 Antigen Test for Self Testing Device ID: 1476 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: CMANU Commercial: CNAME Device ID: 3922 Method: Immunoassay Target: Antibody Format: Fully automated (robot) Go to details
CE Marking: Yes Manufacturer: Diacarta Inc. Commercial: QuantiVirus SARS-CoV-2 Antigen Rapid Test Device ID: 3001 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: DN Laboratory Co. Ltd. Commercial: COVID-19 Neutralizing Antibody Testing Cassette(GICA)/COVID-19 Antigen Testing Cassette(GICA) Device ID: 2955 Method: Immunochromatography Target: Antibody, Antigen, IgA, IgG, IgM Format: Lab-based, Manual, Semi-automated Go to details
CE Marking: Yes Manufacturer: DNA Diagnostic Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) For Self-testing Device ID: 2814 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Dräger Safety AG & Co. KGaA Commercial: Dräger COVID-19 Home Test Device ID: 2647 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Dynamiker Biotechnology(Tianjin) Co. Ltd. Commercial: Dynamiker SARS-CoV-2 Ag Rapid Test Device ID: 3995 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: EON Biotechnology Limited Commercial: EONBT COVID-19 Antigen Device ID: 2032 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Eternal Material Co.,Ltd. Commercial: COVID-19 Antigen Rapid Test For Self Test Device ID: 3453 Method: Immunochromatography Target: Antigen Format: Manual, 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