| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Anitoa | Commercial: 2019 New Coronavirus (2019-nCoV) Test Kit | Device ID: 895 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Anlong Gene | Commercial: 2019-nCov nucleic acid (Fluorescence PCR) | Device ID: 888 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Anlong Gene | Commercial: Detection Kit for 2019-nCov nucleic acid (Fluorescence PCR) | Device ID: 33 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Anlong Gene | Commercial: nConV-19 Nucleic Acid qPCR Kit | Device ID: 35 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ant Medical Limited Company | Commercial: Laborant SARS CoV-2 RT-qPCR Kit | Device ID: 3117 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| 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: Yes | Manufacturer: ArtBioTech LLC | Commercial: ArtTest™ COVID-19 Express Kit | Device ID: 2957 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual, Other | 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: Asterion Otel Ä°nÅŸaat BiliÅŸim Medikal Maden Tic. Ltd. Åžti. | Commercial: Genenzyme SARS-CoV-2 RT-PCR Kit | Device ID: 2961 | Method: RT-PCR | Target: | Format: Lab-based, Manual | 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-2019 Detection Kit | Device ID: 43 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Medical GmbH | 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: Ä°DÄ°L BÄ°OTECH ARAÅžTIRMA SAN. VE TÄ°C. Ltd. ÅžTÄ°. | Commercial: RevoDx SARS-CoV-2 qPCR Kit | Device ID: 2877 | 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: ARMS -PCR Detection Kit for SARS-CoV-2 L452R and E484Q mutations | Device ID: 3050 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: ARMS-PCR Detection Kit for 2019-nCoV HV69-70del and N501Y mutation | Device ID: 3049 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: Duplex Real-Time PCR Detection Kit for 2019-nCoV ORF1ab/N Gene | Device ID: 3052 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: Duplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N | Device ID: 3053 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: Multiple Real-Time PCR Kit for Detection of 2019-nCoV | Device ID: 3054 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | 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: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: Multiplex Real-Time PCR Detection Kit for 17 Species of Respiratory Pathogens | Device ID: 3055 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: Multiplex Real-Time PCR Detection Kit for 27 Species of Respiratory Pathogens | Device ID: 3056 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: Quadruplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N and Influenza Viruses A/B | Device ID: 3057 | 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 Co. Ltd. | 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 Co. Ltd. | 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 |
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