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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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606 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: No Manufacturer: AnyGenes Commercial: Efficient 2019-nCOV detection kit, one step RT-qPCR (N1 & N2) Device ID: 513 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Applied BioCode Commercial: BioCode SARS CoV-2 Assay kit Device ID: 1399 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Applied Biological Materials Inc Commercial: GenomeCoV9 Detection Kit Device ID: 916 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Appolon Bioteck Commercial: Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) Device ID: 514 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: ARUP Laboratories Commercial: COVID-19 Device ID: 702 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: AssayGenie Commercial: COVID-19 CE IVD qPCR assay Device ID: 891 Method: RT-PCR Target: Nucleic acid Format: Automated, Manual Go to details
CE Marking: No Manufacturer: Assurance Scientific Laboratories Commercial: SARS-COV-2 PANEL Device ID: 1400 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd Commercial: SARS-CoV-2 Nucleic Acid Test Kit Device ID: 1578 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Astra Biotech GmbH Commercial: SARS-CoV-2 Triplex PCR kit Device ID: 1132 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Atila BioSystems, Inc Commercial: Atila iAMP COVID-19 SANO Assay Device ID: 2184 Method: LAMP Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Atila BioSystems, Inc Commercial: Atila iAMP COVID-2019 Detection Kit Device ID: 43 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Atlas Medical Commercial: Atlas COVID-19 Real Time RT-PCR Kit Device ID: 774 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Aura Biotechnologies Ltd Commercial: Quick COVID-19 Colorimetric LAMP PCR Device ID: 516 Method: LAMP Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Aura Biotechnologies Ltd Commercial: Quick COVID-19 Realtime Multiplex PCR Device ID: 517 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Aurora Biomed Inc Commercial: SARS-COV-2 Detection Kit for the VERSA Viral Detection workstation Device ID: 45 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: AusDiagnostics Commercial: SARS-CoV-2, Influenza and RSV 8-well Device ID: 46 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Avellino Lab Commercial: Avellino SARS-CoV-2/COVID-19 (AvellinoCoV2) Device ID: 48 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: BAG Diagnostics Commercial: Viro-Q SARS-CoV-2 kit Device ID: 703 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Baicare(Tianjin) Biotechnology Co,. Ltd. Commercial: SARS-CoV-2 Real Time RT-PCR Kit Device ID: 2738 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Bako Diagnostics Commercial: BakoDx SARS-CoV-2 RNA test Device ID: 704 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Bao Ruiyuan Biotech (Beijing) Co., Ltd Commercial: Novel Coronavivus(2019-nCov)Nucleic Acid Detection Kit-Multiple Fluorescence PCR Device ID: 51 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Becton Dickinson Commercial: BD SARS-CoV-2 Reagents for BD MAX System Device ID: 706 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Becton Dickinson Commercial: BD SARS-CoV-2/Flu for BD Max Systems Device ID: 2883 Method: RT-PCR Target: Nucleic acid Format: Automated Go to details
CE Marking: No Manufacturer: Becton Dickinson Commercial: BioGX SARS-CoV-2 Reagents for BD MAX System Device ID: 518 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Beijing Applied Biological Technologies Co., Ltd Commercial: Multiple Real-Time PCR Kit for Detection of 2019-nCoV (manual & automated lab-based) Device ID: 57 Method: RT-PCR Target: Nucleic acid Format: Automated, Lab-based, Manual Go to details
CE Marking: No Manufacturer: Beijing Beier Bioengineering Co., Ltd Commercial: Multiple Real-Time PCR Kit for Detection of 2019-nCoV Device ID: 58 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Beijing Biochem Hengye Science & Technology Development Co., Ltd Commercial: SARS-CoV-2 Real-Time RT-PCR Kit Device ID: 59 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Beijing Bohui Innovation Biotechnology Commercial: Fully Automated 26 Plex RES Panel Assay Device ID: 60 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Beijing Bohui Innovation Biotechnology Commercial: Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Microfluidic Chip) Device ID: 61 Method: RT-PCR Target: Nucleic acid Format: Lab-based 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 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: 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: 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: 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: 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: 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: No Manufacturer: BGI Commercial: 2019-nCoV nucleic acid detection kit using combinatorial probe-anchor synthesis method Device ID: 83 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: BGI Commercial: Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 Device ID: 920 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: BillionToOne, Inc Commercial: qSanger-COVID-19 Assay Device ID: 1401 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Bio Basic Inc Commercial: SARS-CoV- RT-PCR Detection Kit Device ID: 921 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Bio-Rad Laboratories, Inc Commercial: Bio-Rad SARS CoV-2 ddPCR Assay Device ID: 541 Method: Digital-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Biobase Biodustry(Shandong)Co., Ltd. Commercial: 2019-Novel Coronavirus (2019-nCoV) RT-qPCR Detection Kit Device ID: 2900 Method: RT-PCR Target: Nucleic acid Format: Lab-based, Manual Go to details
CE Marking: Yes Manufacturer: Biocartis Commercial: IdyllaTM SARS-COV-2 Test Device ID: 2662 Method: RT-PCR Target: Nucleic acid Format: Fully automated (robot) Go to details
CE Marking: No Manufacturer: Biocerna Commercial: SARS-CoV-2 Test Device ID: 708 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: BioCore Commercial: BioCore 2019-nCoV Real Time PCR Kit Device ID: 1402 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Biodesix Commercial: Biodesix SARS-CoV-2 Droplet Digital PCR (ddPCR ) Test Device ID: 758 Method: Digital-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Biodesix Commercial: SARS-CoV-2 Droplet Digital PCR (ddPCR) test Device ID: 709 Method: Digital-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Bioeksen R&D Technologies Ltd Commercial: Bio-Speedy Direct RT-qPCR SARS-CoV-2 Device ID: 1060 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Bioeksen R&D Technologies Ltd Commercial: Bio-Speedy SARS-CoV-2 (2019-nCoV) qPCR Detection Kit Device ID: 525 Method: RT-PCR Target: Nucleic acid Format: Lab-based 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