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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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2816 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: Aikang Diagnostics Co.,Ltd Commercial: COVID-19 Antigen Test Kit (Saliva) Device ID: 3023 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Aikang Diagnostics Co.,Ltd Commercial: COVID-19 Antigen Test Kit(Immunochromatography) Device ID: 3017 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Aikang Diagnostics Co.,Ltd Commercial: COVID-19 Antigen Test Kit(Nasal/Nasopharyngeal/Oropharyngeal/Saliva) Device ID: 3024 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: AITbiotech Commercial: abTES COVID-19 qPCR I Kit Device ID: 468 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: AITbiotech Commercial: abTES™ Qd COVID‐19 qPCR I Kit Device ID: 3131 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: AITBIOTECH PTE LTD Commercial: abTES COVID-19 Variant qPCR I Kit Device ID: 3119 Method: RT-PCR Target: Format: Automated, Lab-based, Semi-automated Go to details
CE Marking: Yes Manufacturer: AITBIOTECH PTE LTD Commercial: abTES Qd Sample Preparation Kit Device ID: 3130 Method: RT-PCR Target: Other Format: Manual Go to details
CE Marking: Yes Manufacturer: AITBIOTECH PTE LTD Commercial: abTES™ Flu/COVID-19 qPCR I Kit Device ID: 3129 Method: RT-PCR Target: Nucleic acid Format: Automated, Lab-based, Semi-automated Go to details
CE Marking: No Manufacturer: AIVD Biotech Inc Commercial: COVID-19 IgG/IgM Rapid Test (colloidal gold-based) Device ID: 18 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Akralab Commercial: 2019nCoV IgG/IgM Rapid test Device Device ID: 1002 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Aldatu Biosciences Commercial: PANDAA qDx SARS-CoV-2 Device ID: 20 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Alfa Scientific Designs Inc Commercial: DrivenFlow COVID-19 Device ID: 21 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Alfa Scientific Designs Inc Commercial: Instant-view PLUS COVID-19 Test Device ID: 958 Method: Immunoassay Target: Antibody 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: No Manufacturer: ALIMETRIX, INC. Commercial: SARS-CoV-2 (COVID-19) serological test Device ID: 1427 Method: Immunoassay Target: Antibody Format: Lab-based Go to details
CE Marking: Yes Manufacturer: ALLUM SRL Commercial: DAILY TAMPON Device ID: 1852 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: AlphaBiolabs Commercial: AlphaBiolabs IgM-IgG Combined Antibody Rapid Test Device ID: 900 Method: Immunoassay Target: Antibody, IgG, IgM Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Alphadia Commercial: Alphadia Device ID: 1803 Method: Immunoassay Target: IgG Format: Automated Go to details
CE Marking: Yes Manufacturer: Alphagen Bio-Technology Co.,Ltd Commercial: SARS-CoV-2 Antigen Test Kit Device ID: 3965 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Alphagen Bio-Technology Co.,Ltd Commercial: SARS-CoV-2 Antigen Test Kit(Colloidal Gold) Device ID: 3265 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Altona Diagnostics Commercial: RealStar SARS-CoV-2 RT-PCR Kit Device ID: 22 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Amazing Biotech (Shanghai) Co.,LTD Commercial: COVID-19 Antigen Sealing Tube Test Strip (Colloidal Gold) Device ID: 2075 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: AMEDA Labordiagnostik GmbH Commercial: AMP Rapid Test SARS-CoV-2 Ag Device ID: 1304 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: AMEDA Labordiagnostik GmbH Commercial: AMP Rapid Test SARS-CoV-2 IgG/IgM Device ID: 993 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: AMEDA Labordiagnostik GmbH Commercial: Rapid Test SARS-CoV-2 Ag Device ID: 1602 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Amedica SA Commercial: Amela Covid-19 Antigen test Device ID: 829 Method: Immunoassay Target: Antigen Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Amedica SA Commercial: Amela Covid-19 IgM IgG Combo test kit Device ID: 830 Method: Immunoassay Target: Antibody, IgG, IgM Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Amedica SA Commercial: Amela SARS CoV-2 Real time PCR Detection kit Device ID: 831 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Amoy Diagnostics Co., Ltd Commercial: AmoyDx Novel Coronavirus (2019 nCoV) Detection Kit Device ID: 29 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: AMPER INC Commercial: AMPER COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) Device ID: 2936 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: AMPER INC Commercial: AMPER COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) (at-home) Device ID: 2874 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: AMPER INC Commercial: AMPER COVID-19 Neutralizing Antibody Rapid Testing kit (Colloidal Gold) Device ID: 2873 Method: Immunochromatography Target: Antibody Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: AMPER INC Commercial: AMPER RSV Antigen Rapid Test (Colloidal Gold) Device ID: 2870 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: AMPER INC Commercial: Quadruple Fast Test Pen Device ID: 3580 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC 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: SC2Flu Triplex Fast Test (Colloidal Gold) For SARS-CoV-2 & influenza A/B antigens Device ID: 2872 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Amplicon Ltd Commercial: AmpliTest SARS-CoV-2 (Real Time PCR) Device ID: 509 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: AMS UK (NI) Ltd Commercial: 2019-nCoV Antigen Device Device ID: 1203 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: AMS UK (NI) Ltd Commercial: 2019-nCoV Antigen Device (Anterior Nasal Swab) Device ID: 2605 Method: Immunochromatography Target: Antigen Format: Lab-based, Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: AMS UK (NI) Ltd Commercial: 2019-nCoV IgG/IgM Device Device ID: 1048 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: AMS UK (NI) Ltd Commercial: 2019-nCoV Neutralising Antibody Device ID: 2225 Method: Immunochromatography Target: Antibody Format: Lab-based, Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: AMS UK (NI) Ltd Commercial: COVID-19 Antigen ELISA Device ID: 1280 Method: ELISA Target: Antigen Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: AMS UK (NI) Ltd Commercial: COVID-19 Lyophilised Nucleic Acid Kit Device ID: 1052 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Anatolia Geneworks Commercial: Bosphore Novel Coronavirus (2019-nCoV) Detection Kit Device ID: 31 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Anbio (Xiamen) Biotechnology Co., Ltd Commercial: COVID-19 Hybrid Capture Fluorescence Immunoassay Test Device ID: 32 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Anbio (Xiamen) Biotechnology Co., Ltd Commercial: Rapid COVID-19 Antigen Test (Colloidal Gold) Device ID: 1822 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Anbio (Xiamen) Biotechnology Co., Ltd. Commercial: Rapid COVID-19 Antigen Test (Colloidal Gold )/ Saliva Device ID: 2604 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Anbio (Xiamen) Biotechnology Co., Ltd. Commercial: Rapid COVID-19 Antigen Test(Colloidal Gold) Device ID: 2239 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Anhui Deep Blue Medical Technology Co., Ltd Commercial: Colloidal gold strip for SARS-CoV-2 IgG & IgM Device ID: 34 Method: Immunoassay Target: Antibody, IgG, IgM Format: 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 (Colloidal Gold) Device ID: 1736 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